Acronyms of Clinical Trial Terms: Difference between revisions

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==A==
{{CMG}}
*AAAS American Association for the Advancement of Science
*AABB American Association of Blood Banks
*AADA Abbreviated Antibiotic Drug Application (FDA) (used primarily for generics)
*AAMC Association of American Medical Colleges
*AAPP American Academy of Pharmaceutical Physicians
*AAPS American Association of Pharmaceutical Scientists
*ABPI Association of the British Pharmaceutical Industry
*ACC American College of Clinical Pharmacology
*ACDM Association of Clinical Data Management (UK)
*ACIL A national trade association representing independent, commercial scientific, and engineering firms (formerly the American Council of Independent Laboratories)
*ACPU Association of Clinical Pharmacology Units
*ACRA Associate Commissioner for Regulatory Affairs (FDA)
*ACRP Association of Clinical Research Professionals, formerly Associates in Clinical Pharmacology (ACP)
*ACRPI Changed its name to Institute of Clinical Research (UK)
*ACT Applied Clinical Trials magazine
*ACTG AIDS Clinical Trials Group (NIAID)
*ACTU AIDS Clinical Trials Unit (NIH)
*ADaM Analysis Dataset Model (CDISC)
*ADAMHA Alcohol, Drug Abuse, and Mental Health Administration (no longer exists)
*ADE adverse drug event; adverse drug effect
*ADME absorption, distribution, metabolism, and excretion (used to describe pharmacokinetic processes)
*ADR adverse drug reaction
*AE adverse event; adverse experience
*AEGIS ADROIT Electronically Generated Information Service, a subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency’s ADROIT (Adverse Drug Reaction On-line Information Tracking) database.
*AERS Adverse Event Reporting System (FDA)
AFCR See AFMR.
*AFMR American Federation for Medical Research, formerly the American Federation
for Clinical Research (AFCR)
*AHA American Heart Association
*AHCPR Agency for Health Care Policy Research (NIH)
*AICRC Association of Independent Clinical Research Contractors (UK)
*AIDS Acquired immune deficiency syndrome. See also SIDA and HIV in acronym glossary.
*ALCOA attributable, legible, contemporaneous, original, accurate (dimensions of data
quality)
*AMA American Medical Association
*AMC Antibody-mediated cytotoxicity
*AmFAR American Foundation for AIDS Research
*AMG Arzneimittelgesetz (German Drug Law)
*AMWA American Medical Writers Association
*ANDA Abbreviated New Drug Application (for a generic drug)
*ANOVA analysis of variance (statistics)
*ANSI American National Standards Institute
*AOAC Association of Official Analytical Chemists
*APB Association Pharmaceutique Belge (Belgium)
*APhA American Pharmacists Association
*API active pharmaceutical ingredient
*ARCS Association of Regulatory & Clinical Scientists (Australia)
*ARENA Applied Research Ethics National Association
*ARO academic research organization
*ASAP administrative systems automation project (FDA)
*ASCII American Standard Code for Information Interchange (computer files)
*ASCPT American Society for Clinical Pharmacology and Therapeutics
*ASQ American Society for Quality, formerly American Society for Quality Control
*AUC area under the curve (statistics)
*AZT zidovudine (HIV treatment)


==B==
BARQA British Association of
Research Quality Assurance
BCE beneficial clinical event
Glossary
Acronyms, Abbreviations, and Initials
December 2003 actmagazine.com APPLIED CLINICAL TRIALS 25
BDPA Bureau of Drug Policy
and Administration (China)
BEUC European Bureau of
Consumer Unions
BfArM Bundesinstitut für
Arzneimittel und Medizinprodukte
(Federal Institute for
Drugs and Medical Devices,
Germany)
BGA Bundesgesundheitsamt
(Federal health office; former
German public health agency)
BGVV Bundesinstitut für
gesundheitlichen Verbraucherschutz
und Veterinärmedizin
(Federal Institute for Health
Protection of Consumers and
Veterinary Medicine,
Germany)
BIO Biotechnology Industry
Organization
BIRA British Institute of
Regulatory Affairs
BLA Biologics License Application
(FDA)
BPI Bundesverband der
Pharmazeutischen Industrie
EV (Germany)
BrAPP British Association of
Pharmaceutical Physicians
BSA body surface area


==C==
CA Competent Authority
(regulatory body charged with
monitoring compliance with
European Union member
state national statutes and
regulations)
CAPRA Canadian Association
of Pharmaceutical Regulatory
Affairs
CAS Chemical Abstracts
Service
CBER Center for Biologics
Evaluation and Research
(FDA)
CCI Committee on Clinical
Investigations. See also Ethics
Committee box.
CCPPRB Comité Consultative
pour la Protection des Personnes
dans les Recherches
Biomédicales (France). See
also Ethics Committee box.
CCRA Certified Clinical
Research Associate.
Certification issued to monitors by
ACRP.
CCRC Certified Clinical
Research Coordinator.
Certification issued to clinical
coordinators by ACRP.
CCRP Certified Clinical
Research Professional. SOCRA
certification of coordinators,
monitors, and other research
professionals.
CDC Centers for Disease
Control and Prevention
CDER Center for Drug Evaluation
and Research (FDA)
CDISC Clinical Data Interchange
Standards Consortium
(formerly a DIA special
interest group called the
Clinical Data Interchange
Standards Committee)
CDM clinical data
management
CDRH Center for Devices and
Radiological Health (FDA)
CEN Comité Européen de Normalisation
(European Committee
for Standardization)
CEU continuing education unit
CF consent form
CFH Connecting for Health
CFR Code of Federal Regulations
(usually cited by title and
part; for example, Title 21,
Part 211 is shown as 21 CFR
211)
26 APPLIED CLINICAL TRIALS actmagazine.com December 2003
cGMP current good
manufacturing practices
CHI Consolidated Health Initiative (eGov)
CHR Committee on Human Research. See also Ethics Committee box.
CIOMS Council for International Organisations of Medical Sciences (postapproval international
ADR reporting, UK)
CIP Certified IRB Professional
CIS Commonwealth of
Independent States
CLIA Clinical Laboratory
Improvements Amendments
Cmax concentration maximum;
used in pharmacokinetics
and bioequivalence to
indicate maximum plasma
concentration for a drug
CMC chemistry, manufacturing,
and control
CME continuing medical
education
CNS central nervous system
COP CDISC operating
process/procedure
COSTART Coding Symbols for
a Thesaurus of Adverse Reaction
Terms. See also MedDRA.
CPHS Committee for the protection
of human subjects
CPMP Committee for Proprietary
Medicinal Products (EU)
CPSC Consumer Product
Safety Commission (U.S.)
CRA clinical research
associate. See also CCRA
CRADA cooperative research
and development agreement
(with NIH)
CRB case record book
CRB central review board
CRC clinical research coordinator.
See also CCRC, SC, SSC
CRF case report form (sometimes
case record form)
CRO contract research organization.
See also IPRO.
CSDD Center for the Study of
Drug Development
CSF Collaborative Standards
Forum (CDISC)
CSM Committee on Safety of
Medicines (UK)
CSO Consumer Safety Officer
(FDA)
CSR clinical study report
CSU clinical supply unit
CT clinical trial
CTC clinical trial certificate
(UK)
CTD common technical
document
1. The voluntary consent of the human subject is absolutely
essential. This means that the person involved should
have legal capacity to give consent; should be so situated as
to be able to exercise free power of choice, without the intervention
of any element of force, fraud, deceit, duress, overreaching,
or other ulterior form of constraint or coercion; and
should have sufficient knowledge and comprehension of the
elements of the subject matter involved as to enable him to
make an understanding and enlightened decision. This latter
element requires that before the acceptance of an affirmative
decision by the experimental subject there should be
made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted;
all inconveniences and hazards reasonable to be
expected; and the effects upon his health or person which
may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the
consent rests upon each individual who initiates, directs or
engages in the experiment. It is a personal duty and responsibility
which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful
results for the good of society, unprocurable by other methods
or means of study, and not random and unnecessary in
nature.
3. The experiment should be so designed and based on
the results of animal experimentation and a knowledge of the
natural history of the disease or other problem under study
that the anticipated results will justify the performance of the
experiment.
4. The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an
a priori reason to believe that death or disabling injury will
occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that
determined by the humanitarian importance of the problem to
be solved by the experiment.
7. Proper preparations should be made and adequate facilities
provided to protect the experimental subject against even
remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically
qualified persons. The highest degree of skill and care
should be required through all stages of the experiment of
those who conduct or engage in the experiment.
9. During the course of the experiment the human subject
should be at liberty to bring the experiment to an end if he
has reached the physical or mental state where continuation
of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in
charge must be prepared to terminate the experiment at any
stage, if he has probable cause to believe, in the exercise of
the good faith, superior skill and careful judgment required of
him that a continuation of the experiment is likely to result in
injury, disability, or death to the experimental subject.
Reprinted from Trials of War Criminals before the Nuremberg
Military Tribunals under Control Council Law No. 10, Vol. 2, pp.
181–182. Washington, D.C.: U.S. Government Printing Office,
1949.
Nuremberg Code—Directives for Human Experimentation
December 2003 actmagazine.com APPLIED CLINICAL TRIALS 27
CTEP Clinical Therapeutics
Evaluation Program (NCI)
CTM clinical trials materials
CTX clinical trial exemption
(MCA)
CV curriculum vitae
CVM Center for Veterinary
Medicine (FDA)


==D==
''For acronyms of clinical trial names, click [[Clinical trial names|here]]''
DAWN Drug Abuse Warning
Network
DD Department of Drugs
(Swedish regulatory agency)
DEA Drug Enforcement
Administration (U.S.)
DEN Drug Experience Network
DES Data Encryption
Standard
DESI Drug Efficacy Study
Implementation notice (FDA,
to evaluate drugs in use
before 1962)
DGPharMed Deutsche
Gesellschaft für Pharmazeutische
Medizin (German
Society of Pharmaceutical
Medicine), formerly FÄPI
DHEW Department of Health,
Education and Welfare (U.S.,
now split into DHHS and
Department of Education)
DHHS Department of Health
and Human Services (U.S.)
DHTML dynamic HTML (IT)
DIA Drug Information Association
DICOM Digital Imaging and
Communications in Medicine
DLT dose-limiting toxicity
DMB Data Management
Biomedical (France)
DoD Department of Defense
(U.S.)
DPC-PTR Act Drug Price
Competition and Patent Term
Restoration Act of 1984 (also
Waxman-Hatch or Hatch-Waxman
bill)
DSI Division of Scientific
Investigations (FDA)
DSM Diagnostic and Statistical
Manual (of the American
Psychiatric Association)
DSMB Data and Safety Monitoring
Board
DSNP development of
standardized nomenclature
project (FDA)
DTC direct-to-consumer (drug
advertising)
DTD document type definition
(XML)


==E==
; AA: Anaplastic Anaemia
E3C European CDISC
; AAALAC: Association for Assessment and Accreditation of Laboratory Animal Care
Coordinating Committee
; AAALAC: Assoc. for Assessment and Accreditation of Laboratory Animal Care International
EAB Editorial Advisory Board
; AAAS: American Association for the Advancement of Science
(Applied Clinical Trials)
; AABB: American Association of Blood Banks
EAB Ethical advisory board.
; AACR: [http://www.aacr.org/ American Association for Cancer Research]
See also Ethics Committee box.
; AACR: American Association for Cancer Research
EC ethics committee. See also
; AADA: Abbreviated Antibiotic Drug Application
Ethics Committee box.
; AAFP: American Academy of Family Physicians
EC European Commission (in
; AAHRPP: .
documents older than the
; AAI: American Academy of Immunologists
mid-1980s, EC may mean
; AALAS: American Assoc. for Laboratory Animal Science
European Community)
; AAMC: Association of American Medical Colleges
ECG electrocardiogram
; AAP: American Association of Pathologists
ECG European CDISC Group
; AAPS: American Association of Pharmaceutical Scientists
ECJ European Court of
; ABC: Advanced Breast Cancer
Justice
; ABMT: Autologous bone marrow transplant
ECOG Eastern Cooperative
; ABPI: Association of the British Pharmaceutical Industry
Oncology Group (U.S.)
; ABSL: Animal Biosafety Level
ECPHIN European Community
; ABTA: [http://www.abta.org/ American Brain Tumour Association]
Pharmaceutical Products
; ACCP<font> </font>: American College of Clinical Pharmacology
Information Network
; Accrual: the enrollment of qualified patients into clinical trials.
eCRF electronic case report
; Accrue: to enroll qualified patients into clinical trials.
form
; ACDM: Association for Clinical Data Management
EDC electronic data
; ACE: Adverse Clinical Event
capture/collection
; ACIL: American Council of Independent Laboratories
EDI electronic data
; ACIL<font> </font>: A national trade association representing independent, commercial scientific, and engineering firms
interchange
; ACLAM: American College of Laboratory Animal Medicine
EEC European Economic
; ACNP: American College of Nuclear Physicians
Community, now EU; some
; ACOR: Association of Cancer Online Resources
regulatory documents still
; ACOSOG: American College of Surgeons Oncology Group
have EEC document numbers
; ACP: Associates of Clinical Pharmacology
EFGCP European Forum for
; ACPU: Association of Clinical Pharmacology Units
Good Clinical Practice
; ACR: American College of Radiology
EFPIA European Federation of
; ACRA: Associate Commissioner of Regulatory Affairs
Pharmaceutical Industries
; ACRP: Association of Clinical Research Professionals
and Associations
; ACRPI: Association of Clinical Research for the Pharmaceutical Industry
EFTA European Free Trade
; ACRPI: Changed its name to Institute of Clinical Research (UK)
Association
; ACS: [http://www.cancer.org/ American Cancer Society]
EIR Establishment Inspection
; ACS: American Chemical Society
Report (FDA)
; ACT: Applied Clinical Trials
ELA Establishment License
; ACTG: AIDS Clinical Trials Group (DAIDS)
Application (FDA)
; ACTG: AIDS Clinical Trials Group (NIAID)
EMEA European Agency for
; ACTU<font> </font>: AIDS Clinical Trials Unit (NIH)
the Evaluation of Medicinal
; ACT UP: AIDS Coalition to Unleash Power
Products
; ACUC: Animal Care and Use Committee
EMS electronic mail service
; ADaM<font> </font>: Analysis Data Model (a CDISC standard)
EMWA European Medical
; ADaM: Analysis Dataset Model (CDISC)
Writers Association
; ADAMHA: Alcohol, Drug Abuse and Mental Health Administration
EORTC European Organization
; ADE: Adverse Drug Event
for the Research and Treatment
; ADI: Acceptable Daily Intake
of Cancer
; Adjuvant therapy: medical treatment given in addition to a primary treatment. In the case of cancer, this can be chemotherapy, radiation, or hormone therapy given in addition to surgical removal of a tumor, for example. Adjuvant therapies are used to enhance the effect of primary treatment, and would not necessarily be expected to have therapeutic effect in the absence of the primary treatment.
EP European Parliament
; ADME: Absorption, Distribution, Metabolism and Excretion
EPAR European Public
; ADP: Automated Data Processing
Assessment Report
; ADR: Adverse Drug Reaction
EPO European Patent Office
; ADRS: Adverse Drug Reporting System
EPRG European Pharmacovigilance
; AE: Adverse Event (any negative or unwanted effect from a drug, device, or medical test).
Research Group
; AEGIS: ADROIT Electronically Generated Information Service, a subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency’s ADROIT (Adverse Drug Reaction On line Information Tracking) database.
ER Essential Requirements
; AERS: Adverse Event Reporting System (FDA)
(EMEA)
; AFCR: American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)
ESRA European Society of
; AFDO: Association of Food and Drug Officials
Regulatory Affairs
; AFMR: American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)
ESTRI Electronic Standards
; AFP: Alphafetoprotein  eg. expressed by germ cell tumours and other cancers
for the Transfor of Regulatory
; AHA: American Heart Association
Information (ICH)
; AHCPR: Agency for Health Care Policy and Research
EU European Union
; AHCPR: Agency for Health Care Policy Research (NIH)
EUDRA European Union Drug
; AHRQ: Agency for Healthcare Research and Quality
Regulatory Authorities
; AICRC: Association of Independent Clinical Research Contractors (UK)
EUDRACT European Union
; AIDS: Acquired immune deficiency syndrome
clinical trials database
; AIG: Active Ingredient Group
EWG expert working group
; AIM: Active Ingredient Manufacturer
; AIOM: Italian Association for Medical Oncology
; AIP: Abbreviated Inspection Program
; AIRO: Associazione Italiana di Radioterapia Oncologica
; AIUM: American Institute of Ultrasound in Medicine
; AJCC: American Joint Committee on Cancer
; ALARA: As Low As Reasonably Achieved
; ALAT: Alanine aminotransferase / alinine transaminase
; ALCL: Anaplastic Large cell Lymphoma
; ALCOA: attributable, legible, contemporaneous, original, accurate (dimensions of data quality)
; ALL: Acute lymphoblastic leukaemia
; ALT: Alanine Aminotransferase
; am: ante meridian, morning (12:00 midnight thru 11:59:59)
; AMA: American Medical Association
; AMA DE: AMA Drug Evaluations
; AMC: Antibody mediated cytotoxicity
; AMF: Administrative Management of the Files
; AmFAR: American Foundation for AIDS Research
; AMG: West Germany Drug Law
; AMKL: acute megakaryocytic leukemia
; AML: Acute Myeloid leukemia
; AMWA: American Medical Writers Association
; ANADA: Abbreviated New Animal Drug Application
; ANC: Absolute neutrophil count
; ANDA: Abbreviated New Drug Application (for a generic drug)
; ANED: Alive no evidence of disease
; ANLL: Acute non lymphatic leukaemia
; ANOVA: Analysis of variance
; ANSI: American National Standards Institute
; AO: Administrative Official
; AOAC: Association of Official Analytical Chemists
; AOAC: Association of Official Analytical Chemists
; APB: Association Pharmaceutique Belge (Belgium)
; APhA: American Pharmaceutical Association
; APHIS: Animal and Plant Health Inspection Service
; APHIS: Animal and Plant Health Inspection Service (USDA)
; API: active pharmaceutical ingredient
; APPI<font> </font>: Academy of Pharmaceutical Physicians and Investigators
; AQL: Acceptable Quality Level
; ARCS: Association of Regulatory & Clinical Scientists (Australia)
; ARENA: Applied Research Ethics National Association
; ARMS: Alveolar rhabdomyosarcoma
; ARO: academic research organization
; ART: Antiretroviral Therapy
; ASA: American Statistical Association
; ASAP: administrative systems automation project (FDA)
; ASCII<font> </font>: American Standard Code for Information Interchange (computer files)
; ASCO: American Society of Clinical Oncology
; ASCPT: American Society for Clinical Pharmacology and Therapeutics
; ASCPT: American Society for Clinical Pharmacology and Therapeutics
; ASH: American Society for Hematology
; ASM: American Society for Microbiology
; ASO: AIDS Service Organization
; ASQ: American Society for Quality, formerly American Society for Quality Control
; ASR: Age Standardised Rate (Incidence)
; ASTRO: [http://www.astro.org/ American Society for Therapeutic Radiology and Oncology]
; AT: Active (COMIS term)
; ATC: Anatomic Therapeutic Chemical Coding dictionary
; ATF: Bureau of Alcohol, Tobacco, and Firearms
; AU: Authorized User
; AUC: Area Under the Curve (an expression of exposure)
; AV: Attending Veterinarian
; AVAC: AIDS Vaccine Advocacy Coalition
; AVEG: AIDS Vaccine Evaluation Group
; AVMA: American Veterinary Medical Association
; AVRC: AIDS Vaccine Research Committee (also known as Baltimore Committee)
; AWA: Animal Welfare Act (1966)
; AWAR: Animal Welfare Act Regulations
; AWIS: Animal Welfare Information Center
; AWRs: Animal Welfare Regulations (USDA)
; BAA: Broad Agency Announcement
; BACR: British Association for Cancer Research
; BAER: Brainstem Auditory Evoked Responce
; B ALL: B cell Acute Lymphoblastic Leukaemia
; BARQA: British Association of Research Quality Assurance
; BARQA<font> </font>: British Association of Research Quality Assurance
; BASO: British Association of Surgical Oncologists
; BCC: Basal Cell Carcinoma
; BCE: Beneficial Clinical Event
; BCE: beneficial clinical event
; BCHD: Baltimore City Health Department
; BDMC: Biostatistics and Data Monitoring Center
; BDPA: Bureau of Drug Policy and Administration (China)
; BEUC<font> </font>: European Bureau of Consumer Unions
; BfArM<font> </font>: Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)
; BGA<font> </font>: Bundesgesundheitsamt (Federal health office; former German public health agency)
; BGVV<font> </font>: Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany)
; BID: Two Times per Day
; BID / BD: Twice a day (bis in die)
; BIND: Biological Investigational New Drug
; BIO: Biotechnology Industry Organization
; Biospecimen bank: a facility that collects, catalogs, and stores samples of biological materials (such as urine, blood, tissue, cells, DNA, RNA, and protein) used for laboratory research.
; Biostatistics: the use of statistics to analyze biological or health science data.
; BIP: Biomedical Imaging Program
; BIRA: British Institute of Regulatory Affairs
; BLA: Biologics License Application (FDA)
; BM: Bone Marrow
; BMA: British Medical Association
; BMB: Bioresearch Monitoring Branch
; BMI: Body Mass Index
; BMJ: British Medical Journal
; BMR: Basal Metabolic Rate
; BMT: Bone Marrow Transplant
; BNF: British National Formulary
; BNLI: British National Lymphoma Investigation
; BOA: British Oncology Association
; BODMA: British Oncology Data Managers Association (UK)
; BOV: Board of Visitors
; BP: Blood pressure
; BPI: Bundesverband der Pharmazeutischen Industrie EV (Germany)
; BPM: Beats Per Minute
; BrAPP: British Association of Pharmaceutical Physicians
; BrAPP<font> </font>: British Association of Pharmaceutical Physicians
; BRB: Biomedical Research Branch
; BREF: Baltimore Research and Education Foundation (at Baltimore VA)
; BRIDG<font> </font>: Biomedical Research Integrated Domain Group
; BRM: Biological Response Modifier
; BSA: Body Surface Area
; BSE: Breast Self Examination
; BSL: Biosafety Level
; BVC: British Veterinary Codex
; Bx: Biopsy
; C & S: Culture and Sensitivity
; C/O: Complaining of
; C/W: Continue With
; C1  C7: Cervical vertebrae (spine eg. C7 = seventh cervical vertebra)
; Ca: Cancer; carcinoma
; CA: Chemical Abstracts
; CA: Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations)
; CAAT: Center for Alternatives to Animal Testing
; CAB: Community Advisory Board
; CaBig<font> </font>: Cancer Biomedical Informatics Grid
; CAC: Carcinogenicity Assessment Committee
; CACE: Committee for Advancement of Chemistry Education
; caDSR<font> </font>: Cancer Data Standards Repository and toolset maintained by NCI
; CALGB: [http://www-calgb.uchicago.edu/ Cancer and Leukemia Group B (USA)]
; cALL: Common ALL
; CANDA: Computer Assisted New Drug Application
; CAP: College of American Pathologists
; CAPLA: Computer Assisted Product License Application
; CAPRA: Canadian Association of Pharmaceutical Regulatory Affairs
; CAPRA<font> </font>: Canadian Association of Professional Pharmaceutical Regulatory Affairs (also ACPR Association canadienne des professionnels en réglementation)
; CAQ: Certificate of Added Qualifications
; CAS: Chemical Abstracts Service
; CAS: Chemical Abstracts Service
; CASB: Cost Accounting Standards Board
; CAT: Computerised axial tomography (scan)
; CBC: Complete Blood Count
; CBCTN: Community Based Clinical Trials Network
; CBER: Center for Biologics Evaluation and Research
; CBO: Community Based Organization
; cc: Cubic centimeter
; CCASE: Coordinating Committee for Advancement of Scientific Education
; CCC: Compliance Coordinating Committee (CDER)
; CCF: Congestive Cardiac Failure
; CCG: [http://www.nccf.org/nccf/ccg_who.htm Children's Cancer Group (USA)]
; CCI: Committee on Clinical Investigations. See also Ethics Committee box.
; CCM: Center for Comparative Medicine
; CCOP: Community Clinical Oncology Program
; CCPPRB<font> </font>: Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also Ethics Committee box in the Glossary.
; CCR: Continuous complete remission
; CCRA: Certified Clinical Research Associate. Certification issued to monitors by ACRP.
; CCRC: Certified Clinical Research Coordinator
; CCRC: CTSC Clinical Research Center
; CCRG: Children's Cancer Research Group (Oxford, UK)
; CCRP: Certified Clinical Research Professional (SoCRA)
; CCS: Canadian Cancer Society
; CCSI: Company Core Safety Information
; CCT: Center for Clinical Trials, School of Medicine (UMB)
; CDA: Confidential Disclosure Agreement
; CDA: Clinical Document Architecture (HL7)
; CDASH<font> </font>: Clinical Data Acquisition Standards Harmonization (a 2006 CDISC initiative)
; CDC: Centers for Disease Control and Prevention
; CDE<font> </font>: common data element
; CDER: Center for Drug Evaluation and Research
; CDISC: Clinical Data Interchange Standards Consortium(formerly a DIA special interest group called the Clinical Data Interchange Standards Committee)
; CDM<font> </font>: clinical data management
; CDMS<font> </font>: clinical data management system
; CDRH: Center for Devices and Radiological Health
; CDUS: Clinical Data Update System
; CEA: Carcinoembryonic Antigen (tumour marker)
; CEN: Comité Européen de Normalisation(European Committee for Standardization)
; CESS: CDER Executive Secretariat Staff
; CEU: continuing education unit
; CF: Consent Form
; CFDA: Catalog of Federal Domestic Assistance
; CFH: Connecting for Health
; CFR: Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211)
; CFSAN: Center of Food Safety and Applied Nutrition
; CGH: Comparative Genomic Hybridisation  cytogenetics method
; CGMP: Current Good Manufacturing Practice
; cGy: Centi Gray (unit of radiation)
; CH: Clinical Hold
; CHAVI: Center for HIV/AIDS Vaccine Immunology
; CHF: Congestive heart failure
; CHI<font> </font>: Consolidated Health Initiative (eGov)
; CHR: Committee on Human Research. See also Ethics Committee box.
; CIB: Clinical Investigator's Brochure
; CIC<font> </font>: clinical imaging center
; CID: CTFA Cosmetic Ingredient Dictionary
; CIOMS: Council for International Organizations of Medical Sciences
; CIP: Cancer Imaging Program
; CIP: Certified IRB Professional
; CIR: Cosmetic Ingredient Review
; CIRA: Center for Information on Research with Animals
; CIS: Commonwealth of Independent States
; CITI: Collaborative Institutional Training Initiative
; CLIA: Clinical Laboratory Improvement Amendments
; CLL: Chronic lymphocytic Leukaemia
; cm: centimeter  0.01 meters
; Cmax: concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug
; CMC: Chemistry and Manufacturing Controls
; CMC: Contaminated Materials Container
; CMCCC: Chemistry and Manufacturing Controls Coordinating Committee (CDER)
; CME: Continuing Medical Education
; CMMS: Centers for Medicare and Medicaid Services
; CMS<font> </font>: Centers for Medicare & Medicaid Services
; CNS: Central nervous system  the brain and spine
; COE: Code of Ethics
; COG: Cooperative Oncology Group (USA)
; COI: Conflict of Interest
; COLA: Cost of Living Adjustment
; COMIS: Center Office Management Information System
; CONSORT<font> </font>: Consolidated Standards of Reporting Trials
; COP<font> </font>: CDISC Operating Process/Procedure
; CORE<font> </font>: CDISC Operational Roadmap Environment (CDISC)
; COS: [http://www.cos.ca/ Canadian Oncology Society]
; COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms
; COSTART: Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA.
; CP: Compliance Program
; CP: Community Partners
; CPCRA: The Terry Beirn Community Programs for Clinical Research on AIDS (DAIDS)
; CPHS: Committee for the protection of human subjects
; CPMP: Committee for Proprietary Medicinal Products
; CPMP: Committee for Proprietary Medicinal Products (EU)
; CPR: Cardio pulmonary resuscitation
; CPSC: Consumer Product Safety Commission
; CR: Complete remission / complete response
; CR: Cross Reference (COMIS term)
; CRA: Clinical Research Associate
; CRADA: Cooperative Research and Development Agreement
; CRB<font>  </font>: case record book
; CRB: central review board
; CRC: [http://www.crc.org.uk/ Cancer Research Campaign (UK)]
; CRC: Clinical Research Coordinator
; CRF: Case Report Form
; CRIS: Current Research Information Service
; CRISP: Computer Retrieval of Information on Scientific Programs (NIH)
; CRIX<font> </font>: Clinical Research Information Exchange
; CRO: Contract Research Organisation
; CRS: Clinical Research Site
; CS: Clinically Significant
; CSA or CTA: Clinical Study Agreement or Clinical Trial Agreement
; CSDD: Center for the Study of Drug Development
; CSF: Cerebro spinal fluid
; CSF: Collaborative Standards Forum (CDISC)
; CSF<font> </font>: colony stimulating factor
; CSI: Consumer Safety Inspector
; CSM: Committee on Safety of Medicines (UK)
; CSO: Consumer Safety Officer (FDA)
; CSR: clinical study report
; CSU: clinical supply unit
; CSUICI<font> </font>: (replaces CSUCT) Computerized Systems Used In Clinical Investigations. NOTE: usually pronounced "seesweecy."
; CT: Computed tomography
; CT<font> </font>: clinical trial
; CT(X): Clinical Trial Exemption
; CTA: Clinical Trial Agreement
; CTC: Computerized tomographic colonography
; CTC: Clinical Trial Certificate
; CTC: Clinical Trials Coordinator
; CTEP: Clinical Therapeutics Evaluation Program (NCI)
; CTM: Clinical Trials Manager
; CTM<font> </font>: clinical trials materials
; CTO: Clinical Trials Office
; CTP: Clinical Trials Physician
; CTSC: Clinical and Translational Science Center
; CTSC: Clinical Research Training Program
; CTSU: Clinical Trials Support Unit
; CTU: Clinical Trials Unit
; CTWG: Community Training Working Group
; CTX: Clinical Trials Exemption
; CTX: Clinical Trial Exemption Certification
; CUI: common unique identifier. A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.
; CV: Curriculum Vitae
; CVA: Cardiovascular Accident (stroke)
; CVC: Central venous catheters
; CVM: Center for Veterinary Medicine
; CVM: Center for Veterinary Medicine (FDA)
; CVP: Central Venous Pressure
; CXR: Chest X Ray
; D/C: Discharge
; D/H: Drug History
; D/W: Discussed With
; DAIDS: Division of AIDS (NIAID)
; DAS: Drug Abuse Staff
; DAWN: Drug Abuse Warning Network
; DB: Double Blind
; DC: Direct Costs
; DCE MRI: Dynamic contrast enhanced MRI
; DCF: Data Correction Form / Data Clarification Form
; DCIS: Ductal Carcinoma In Situ  type of breast cancer
; DCTD: Division of Cancer Treatment and Diagnosis at the NCI
; DD: Department of Drugs(Swedish regulatory agency)
; DDF<font> </font>: Data Definition File
; DDI: drug–drug interaction
; DDIR: Division of Drug Information Resources
; DDMAC: Division of Drug Marketing, Advertising, and Communications
; DDx: Differential diagnosis
; DEA: Drug Enforcement Administration
; DEN: Drug Experience Network
; DEN<font> </font>: Drug Experience Network
; DEQ: Department of Environmental Quality
; DES: Division of Epidemiology and Surveillance
; DES: Data Encryption Standard
; DESI<font> </font>: Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962)
; DFI: Disease Free Interval
; DFS: Disease Free Survival  time without disease prior to relapse or last follow up
; DGPharMed<font> </font>: Deutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly ÄPI
; DHEW: Department of Health,Education and Welfare (U.S.,now split into DHHS and Department of Education)
; DHHS: Department of Health and Human Services
; DHR: Maryland Department of Human Resources
; DHTML: dynamic HTML (IT)
; DI: Diabetes Incipidus
; DIA: Drug Information Association
; DICOM: Digital imaging and communication in medicine
; DIS: Decay in Storage
; DISD: Division of Information Systems Design
; dl: deciletre  0.01 litres
; DLBCL: Diffuse Large B cell Lymphoma
; DLCL: Diffuse large cell lymphoma
; DLT: Dose limiting toxicity  determined by phase 1 studies
; DLT: dose limiting toxicity
; DM: Data management
; DMB: Data Management Biomedical (France)
; DMC: Data Monitoring Committee
; DMF: Drug Master File
; DMIST: Digital Mammographic Imaging Screening Trial
; DNR: Do Not Resusitate
; DOA: Dead on Arrival
; DOD: Department of Defense
; DOS: Description of Study
; DPC PTR Act: Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman Hatch or Hatch Waxman bill)
; DRG: Diagnosis Related Groups
; DSI: Division of Scientific Investigations
; DSM: Diagnostic and Statistical Manual (of the American Psychiatric Association)
; DSMB: Data and Safety Monitoring Board
; DSMC: Data and Safety Monitoring Committee
; DSNP: development of standardized nomenclature project (FDA)
; DSTU<font> </font>: Draft Standard for Trial Use. See HL7 definition .
; DSUR<font> </font>: Development Safety Update Report (ICH)
; DTC: direct to consumer (drug advertising)
; DTD<font> </font>: Document Type Definition (XML)
; DUR: Drug Utilization Review
; DWI: Diffusion weighted imaging
; Dx: Diagnosis
; E3C<font> </font>: European CDISC Coordinating Committee
; EA: Environmental Assessment
; EAB: Ethical Advisory Board
; EAB<font> </font>: Editorial Advisory Board (Applied Clinical Trials )
; EACR: [http://www.oncoweb.com/EACR/ European Association for Cancer Research]
; EANO: European Association for NeuroOncology
; EBM: Evidence Based Medicine
; EBMT: European Group for Blood and Marrow Transplantation
; EC: European Commission
; EC: Ethics Committee
; ECG: Electrocardiogram
; ECG<font> </font>: European CDISC Group
; ECOG<font> </font>: Eastern Cooperative Oncology Group
; ECPHIN<font> </font>: European Community Pharmaceutical Information Network
; eCRF<font> </font>: electronic case report form
; ECRIN<font> </font>: European Clinical Research Infrastructures Network
; eCTD<font> </font>: electronic common technical document
; ED: Effective Dose
; EDC: Electronic Data Capture
; EDC<font> </font>: electronic data capture/collection
; EDI<font> </font>: electronic data interchange
; eDMS<font> </font>: electronic data management system
; EDR: electronic document room. NOTE: The EDR is an extension of the e Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links.
; EEG: Electroencephalogram
; EER: Establishment Evaluation Request
; EFGCP<font> </font>: European Forum for Good Clinical Practice
; EFPIA: European Federal of Pharmaceutical Industries Associations
; EFS: Event Free Survival  time from diagnosis to defined events (eg relapse or deat
; eHR<font> </font>: electronic health record
; EHS: Environmental Health and Safety
; EIA: Establishment Inspection Reports
; EICESS: [http://www.staff.ncl.ac.uk/s.j.cotterill/eicess.htm European Intergroup Ewing's Sarcoma Study]
; EIN: Entity Identification Number
; EIR: Establishment Inspection Report
; EJC: European Journal of Cancer
; ELA: Establishment License Application
; ELISA: Enzyme Linked Immunosorbent Assay (test)
; ELISpot: Enzyme Linked Immunospot (assay)
; EMEA<font> </font>: European Medicines Agency
; EMERSE: Electronic Medical Record Search Engine
; EMUO: Early Morning Urine Osmolality (evaluating urine concentration)
; EMWA<font>  </font>: European Medical Writers Association
; ENSG: European Neuroblastoma Study Group
; ENT: Ear nose throat
; EO: Executive Order
; EOI: European Osteosarcoma Intergroup
; EOP1: End of phase 1
; EOP2: End of phase 2
; EORTC: [http://www.eortc.be/ European Organisation for Research and Treatment of Cancer]
; EOS: End of Study
; EPA: Environmental Protection Agency
; EPAR<font> </font>: European Public Assessment Report
; EPL: Effective Patent Life
; EPMS: Employee Performance Management System
; EPO: European Patent Office; erythropoietin
; EPRG<font> </font>: European Pharmacovigilance Research Group
; ER<font> </font>: Essential Requirements (EMEA)
; ERA: Electronic Research Administration
; ERISA: Employee Retirement Insurance Security Act
; Erlotinib (Tarceva): (Tarceva) a drug used to treat locally advanced or metastatic non small cell lung cancer and other cancers. Like gefitinib, it targets epidermal growth factor receptor tyrosine kinase, and specific genetic mutations correlate to patients’ response to the drug.
; ERSR: electronic regulatory submissions and review (FDA's e Submissions processing group)
; eRX<font>  </font>: electronic prescribing
; eSDI<font>  </font>: electronic Source Data Interchange
; ESO: [http://telescan.nki.nl/eso/ European School of Oncology]
; ESR: Erythrocyte Sedimentation rate
; ESRA<font> </font>: European Society of Regulatory Affairs
; ESS: Executive Secretary and Staff
; ESTRI<font> </font>: Electronic Standards for the Transfer of Regulatory Information (ICH)
; ESTRO: European Society for Therapeutic Radiation and Oncology
; ETS: Environmental Tobacco Smoke
; ETT: Exercise Tolerance Test
; EUDRA<font> </font>: European Union Drug Regulatory Authorities
; EudraCT<font>  </font>: European Union clinical trials database
; EUP: Experimental Use Permit
; EUROVAC: European Vaccine Effort Against HIV/AIDS
; EVS<font> </font>: Enterprise Vocabulary Services (National Cancer Institute)
; EWG<font> </font>: expert working group
; F&A Costs: Facilities and Administrative Costs
; F/H: Family history
; FAB: French American and British classification scheme for leukaemia
; FACA: Federal Advisory Committee Act 1972
; FAR: Federal Acquisition Regulation
; FBC: Full Blood Count
; FCCSET: Federal Coordinating Council for Science, Engineering and Technology
; FD & C Act: Federal Food, Drug and Cosmetic Act
; FDA: Food and Drug Administration (USA)
; FDA 1572: FDA Form for Statement of Investigator
; FDA 482: Notice of Inspection
; FDA 483: Notice of Adverse Findings in an Inspection
; FDAAA: Food and Drug Administration Amendment Act (pronounced fedaahh or fedah ah)
; FDAMA<font>  </font>: FDA Modernization Act
; FDA SRS: Spontaneous Reporting System of the Food and Drug Administration
; FDCA: Food, Drug, and Cosmetic Act
; FDG PET: Fluorodeoxyglucose PET
; FDLI: Food and Drug Law Institute
; FDP: Federal Demonstration Partnership
; FECS: Federation of European Cancer Societies
; FEV: Forced expectorant volume (a lung test)
; FFA: For Further Appointment
; FFDCA: Federal Food, Drug, and Cosmetic Act
; FFPM<font> </font>: Fellow of the Faculty of Pharmaceutical Medicine (UK)
; FHCRC: Fred Hutchinson Cancer Research Center
; FHI: Family Health International
; FIC: Fogarty International Center, NIH
; FIGO: International Federation of Gynecology and Obstetrics
; FIPS<font> </font>: Federal Information Processing Standards
; FISH: Flourescence in situ Hybridisation
; FMD: Field Management Directives
; FMTC: Familial Medullary Thyroid Carcinoma
; FNA: Fine Needle Aspiration  a type of biposy using a thin needle (or FNAB)
; FOI: Freedom of Information
; FOIA: Freedom of Information Act
; FONSI: Finding of No Significant Impact
; FPL: Final Printed Labeling
; FPR: Final Proposal Revision
; FRC: Federal Records Center (Suitland)
; FRCP: Fellow of the Royal College of Physicians, sometimes followed by a place name for example, FRCP (Edin.) that indicates a university medical school
; FSIS: Food Safety and Inspection Service
; FTE: Full Time Equivalent
; FU: Follow up
; FUR: Follow up Request
; FVC: Forced Vital Capacity
; FWA<font> </font>: Federalwide Assurance
; g: gram  unit of weight
; GA: General Anaesthetic
; GAO: General Accounting Office
; GATT: General Agreement of Tariffs and Trade
; GBP<font> </font>: good business practice
; Gbps<font> </font>: gigabits, or billions of bits per second (data transmission)
; GC: General Counsel (FDA)
; GCAB: Global Community Advisory Board
; GCP: Good clinical practice
; GCRC: General Clinical Research Center
; GCRP: good clinical research practice
; GDA: Global Disclosure Agreement
; GFR: Gromerular filtration rate
; GI: Gastrointestinal
; GI: Gastrointestinal
; GLP: Good Laboratory Practice
; GMC: General Medical Council (UK)
; GMO: Grants Management Officer
; GMP: Good Manufacturing Practice
; GOG: Gynecology Oncology Group
; GP<font> </font>: general practitioner; general practice (UK)
; GPMS<font> </font>: good postmarketing surveillance practice (Japan)
; GPOH: Gesellschaft fur Padiatrische Onkologie und Hamatologie (German Paed. Onc Group)
; GPR: Good Partial Remission
; GPRA: Government Performance and Results Act
; GQA: General Qualifying Application
; Grade 1 toxicities: mild adverse events.
; Grade 3 toxicities: severe adverse events.
; Grade 4 toxicities: life threatening or disabling adverse events.
; GRAS: Generally Recognized as Safe
; GRASE: Generally Recognized as Safe and Effective
; GRP: Good Review Practice
; GU: Genito urinary
; GXP: good (pharmaceutical) practice
; Gy: Grays (units of radiation)
; H&E: Hematoxylin and Eosin (stain)
; H/O: History of
; HA: health authority (UK)
; HAACP: Hazard Analysis and Critical Control Point (inspection technique)
; HAART: Highly Active Antiretroviral Therapy
; HAI: Health Action International
; HANC: HIV/AIDS Network Coordination
; Hb: Haemoglobin
; HCFA<font> </font>: Health Care Financing Administration; now renamed The Centers for Medicare & Medicaid Services (CMS).
; HCPCS modifier: An HCPCS code descriptor utilized to provide additional information regarding the service or item identified by the HCPCS code, including specific circumstances that may apply to the service or item.
; HDC: High Dose Chemotherapy
; HEPA: High Efficiency Particulate Air Filter
; HEX: Human Experimentation Committee. See also Ethics Committee box in the Glossary.
; HF: Routing code for mail to the Office of the Commissioner of the FDA
; HFD: Routing code for mail to CDER
; HFM: Routing code for mail to CBER
; HFS: Routing code for mail to CFSAN
; HFT: Routing code for mail to NCTR
; HFV: Routing code for mail to CVM
; HFZ: Routing code for mail to CDRH
; HHS: Health and Human Services (Department of)
; HHS<font> </font>: Department of Health and Human Services (U.S., also called DHHS)
; HIC: Human Investigation Committee(former name of HSR)
; HIE<font> </font>: health information exchange
; HIMA<font>  </font>: Health Industry Manufacturers Association
; HIMSS<font> </font>: Healthcare Information and Management Systems Society (pronounced hymns)
; HIPAA: Health Insurance Portability and Accountability Act
; HIRE: Human Investigations Involving Radiation Exposure (subcommittee of RSC)
; HIT: health information technology
; HITSP: Health Information Technology Standards (pronounced hitspee)
; HIV: Human Immunodeficiency Virus
; HIVNET: HIV Network for Prevention Trials – United States (Closed October 1999)
; HL7: Health Level 7 (a not for profit ANSI accredited standards developing/development organization [SDO])
; HL A: Human Leukocyte Associated antigens (HL A matching for BMT)
; HLA: Human Leucocyte Antigen
; HMO: Health Maintenance Organization
; HNPCC: Hereditary NonPolyposis Colorectal Cancer
; HP: Health Physicist
; HPA: Human Protections Administration
; HPB<font> </font>: Health Protection Branch, Laboratory Centre for Disease Control (Canada); has been superseded by Health Canada
; HPLC<font> </font>: high performance liquid chromatography
; HPTN: HIV Prevention Trials Network
; HPTU: HIV Prevention Trials Unit
; HPV: Human Papilloma Virus  implicated in some gynacological cancers
; HR: High risk
; HRG: Health Research Group
; HRRC: Human Research Review Committee
; HRSA: Health Resources and Services Administration
; HRT: Hormone replacement therapy
; HRW: High Risk Women
; HSRC<font> </font>: Human Subjects Review Committee. See also Ethics Committee box in the Glossary .
; HTLV: Human T cell leukemia lymphoma virus
; HTML<font> </font>: Hypertext Markup Language
; HTTP<font> </font>: Hypertext Transfer Protocol
; HVTN: HIV Vaccine Trials Network
; HVTU: HIV Vaccine Trials Unit
; HX: History
; I3C<font> </font>: India CDISC Coordinating Committee
; IAB<font> </font>: Industry Advisory Board (for CDISC)
; IACR: International Association of Cancer Registries
; IACUC: Institutional Animal Care and Use Committee
; IARC: [http://www.iarc.fr/ International Agency for Research on Cancer]
; IASLC: [http://www.iaslc.org/ International Association for the Study of Lung Cancer]
; IAVI: International AIDS Vaccine Initiative
; IB: Investigator’s Brochure
; IBC: Institutional Biosafety Committee
; IC: Informed consent
; IC: Chemistry Information Amendment (COMIS term)
; IC<font> </font>: informed consent
; ICARE: International Cancer Alliance for Research and Education (ICARE)
; ICASO: International Council of AIDS Service Organizations
; ICCCPO: [http://icccpo.org/ International Confederation of Childhood Cancer Parent Organisations]
; ICCG: International Collaborative Cancer Group
; ICCPO: Icelandic Childhood Cancer Parent Organisation
; ICD: International Classification of Diseases (coding system)
; ICD: Informed Consent Document
; ICD9: International Classification of Diseases, 9th revision. See also MedDRA.
; ICD 9 CM: International Classification of Disease Codes, 9th revision Clinical Modification
; ICDO: International Classification of Diseases for Oncology (coding system)
; ICF: Intercellular fluid
; ICF: informed consent form
; ICG<font> </font>: India CDISC Group
; ICH: International Conference on Harmonization (GCP)
; ICH GCP: ICH Harmonised Tripartite Guideline for Good Clinical Practices
; ICLAS: International Council for Laboratory Animal Sciences
; ICMJE: International Committee of Medical Journal Editors
; ICPEMC: International Commission for Protection Against Mutagens and Carcinogens
; ICR<font> </font>: Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK)
; ICRF: [http://www.icnet.uk/ Imperial Cancer Research Fund (UK)]
; ICSR<font> </font>: individual case safety report
; ICTH: International Committee on Thrombosis and Hemostases
; ICTRP<font> </font>: International Clinical Trials Registry Platform (WHO)
; ICU: Intensive Care Unit
; IDB: Investigational Drug Brochure
; IDC: Indirect costs
; IDE<font> </font>: Investigational Device Exemption Application to CDRH to get permission for investigational device testing in clinical trials
; IDR: Idiosyncratic Drug Reaction
; IDS: Investigational Drug Service (pharmacy)
; IDSMB: Independent Data Safety Monitoring Board
; IDU: Injecting Drug User
; IEC: Independent Ethics Committee
; IEEE<font> </font>: Institute of Electrical and Electronic Engineers, Inc.
; IESS: Intergroup Ewing's Sarcoma Study (USA)
; IFAPP<font>  </font>: International Federation of Associations of Pharmaceutical Physicians
; IFN: Interferon
; IFPMA<font>  </font>: International Federation of Pharmaceutical Manufacturers and Associations
; IG: Inspector General
; IG: Immunoglobulin
; IHE<font> </font>: Integrating the Healthcare Enterprise (an international standards organization)
; IHI<font>  </font>: Institute for Healthcare Improvement
; IHS: Indian Health Service
; IKS<font> </font>: Interkantonale Kontrollstelle für Heilmittel (Switzerland)
; IL: Interleukin
; IL2: Interleukin2
; ILAR: Institute for Laboratory Animal Research
; IM: Intramuscular  into a muscle
; IM: Clinical Information Amendment (COMIS term)
; IMI<font>  </font>: Innovative Medicines Initiative (European Commission)
; IMP<font> </font>: investigational medicinal product; investigational materials plan
; IMPAACT: International Maternal Pediatric Adolescent AIDS Clinical Trial Group
; IMPD<font> </font>: Investigational Medicinal Product Dossier (EUDRA)
; IMRT: Intensity Modulated Radiotherapy
; INAD: Investigational New Animal Drug
; IND: Investigational new drug
; INDA: Investigational New Drug Application
; INDC: Investigational New Drug Committee
; INFA: [http://nf.org/Docs/infa.html International Neurofibromatosis Association]
; INN: International Nonproprietary Name
; INSS: International Neuroblastoma Staging System
; Investigational New Drug (IND): A new molecular, antibiotic, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
; IO: Institutional Official
; IOM<font> </font>: Institute of Medicine (National Academy of Science, U.S.)
; IOM: Institute of Medicine
; IPC: Institutional Participants Committee
; IPCS: International Program for Chemical Safety
; IPRA: International Product Registration Document
; IPRO: Independent Pharmaceutical Research Organization
; IPRO<font> </font>: independent pharmaceutical research organization. See also CRO.
; IPSO: International Society of Pediatric Surgical Oncology
; IRB: Institutional Review Board
; IRB HSR: Institutional Review Board Health Sciences Research
; IRC: Institutes Review Committee
; IRD<font> </font>: international registration document
; IRG: Integrated Review Group (NIH peer review)
; IRG: Initial Review Groups
; IRS: Identical, Related, or Similar
; IS: International System of Units (may also be referred to as SI Systéme Internationale)
; ISCB<font>  </font>: International Society for Clinical Biostatistics
; ISDN<font> </font>: Integrated Services Digital Network
; ISNCC: [http://www.isncc.org/ International Society of Nurses in Cancer Care]
; ISO<font> </font>: International Organization for Standardization
; ISOQOL<font> </font>: International Society for Quality of Life Research
; ISP<font> </font>: Internet service provider
; ISPE: International Society for Pharmacoepidemiology
; IT: Information Technology
; ITCC: Information Technology Coordinating Committee (CDER)
; ITU: Intensive Therapy Unit
; ITU T: International Telecommunication Union Telecommunication Standardization Sector
; IU: International units
; IUPAC<font> </font>: International Union of Pure and Applied Chemistry
; IV: Intravenous  into a vein
; IVD: In Vitro Diagnostics
; IVP: Intravenous Pyelogram  type of Xray after injection with iodine dye
; J3C<font> </font>: Japan CDISC Coordinating Committee
; JCAH: Joint Commission for the Accreditation of Hospitals
; JCAHO: Joint Commission on Accreditation of Health Care Organizations
; JCG<font> </font>: Japan CDISC Group
; JCO: Journal of Clinical Oncology
; J Code: An HCPCS code used to bill payors (such as CMS or insurance companies) for drugs. A J code, as opposed to another letter code (i.e., A code or B code), generally signifies an injectable drug that cannot be self administered.
; JCPT: Journal of Clinical Pharmacology and Therapeutics
; JCRDD: Journal of Clinical Research and Drug Development
; JCRP: Journal of Clinical Research and Pharmacoepidemiology
; JMA<font>  </font>: Japan Medical Association
; JPA: Joint Personnel Agreement
; JPMA: Japan Pharmaceutical Manufacturers Association
; K+: Potassium
; Kbps<font> </font>: kilobits, or thousands of bits per second (data transmission)
; kg: Kilogram  a thousand grams
; LAB<font> </font>: Laboratory Data Model (CDISC)
; LATA: Laboratory Animal Training Association
; LCH: Langerhans cell histiocytocis
; LCIS: Lobular Carcinoma In Situ  type of breast cancer
; LD: Lethal Dose
; LD50: Lethal Dose (50%)
; LDH: Lactic dehydrogenase  high levels correlate with tumour volume in some cancers
; LEAA: Law Enforcement Assistance Administration
; LERN: Library Electronic Reference Network
; LIF<font> </font>: Swedish Pharmaceutical Industry Association
; LKP<font> </font>: Leiter der Klinischen Prüfung
; LMP: Low Malignant Potential (context: ovarian tumours)
; LN: Lymph Node
; LNC: Labeling and Nomenclature Committee
; LOC: Level of Concern
; LOCF: Last Observation Carried Forward
; LOINC<font> </font>: logical observations, identifiers, names, and codes
; LP: Lumbar puncture
; LPP: Local Partnership Project
; LRC: Lipid Research Clinic
; LREC: Local Research Ethics Committee (UK)
; LRF: Leukaemia Research Fund (UK)
; LRFA: [http://www.lymphoma.org/lrfa.html Lymphoma Research Foundation of America]
; LRI: Lower Respiratory Infection
; LTE: Less Than Effective
; LVEF: Left Ventricular Fjection Fraction  a heart function test
; Lx: Lumpectomy
; m: meter (unit of length)
; M/H: Medical history
; MA<font> </font>: marketing authorization
; MAA<font> </font>: Marketing Authorisation Application (EMEA, EU)
; MAB  mAb: Monoclonal antibody
; MACS: Multi center AIDS Cohort Studies
; MAH<font> </font>: Marketing Authorisation Holder (EU)
; MAPP: Manual of Policy and Procedures
; MBC: Minimum Bactericidal Concentration
; MBE: Minority Business Enterprise
; Mbps<font> </font>: megabits, millions of bits per second (data transmission)
; MCA: Medicines Control Agency (UK)
; MDI: Metered Dose Inhaler
; MDR: Multi drug resistant
; MDR: Medical Device Reporting
; MDS: Myelo dysplastic syndrome
; MedDRA<font> M</font>: Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others)
; MedID<font>  </font>: Medicinal Product Identifier
; MEDLARS: Medical Literature Analysis and Retrieval System
; MEDWATCH:
; MEFA<font>  </font>: Association of the Danish Pharmaceutical Industry
; MEN: Multiple Endocrine Neoplasia  (familial) a.k.a. FMEN
; mEq/l: milliequivalent per liter
; MERIT: Method to Extend Research in Time award (NIH)
; mets: Metastases (where the tumour has spread to secondary sites)
; Mg: Magnesium
; MHC: Major Histocompatibility Complex
; MHLW: Ministry of Health, Labor and Welfare (Japan)
; MHRA<font>  </font>: Medicines and Healthcare products Regulatory Agency (UK)
; MHW: Ministry of Health and Welfare (Japan's equivalent to the FDA)
; MI: Miocardial Infarction
; MI: Myocardial Infarction
; MIAME<font> </font>: minimum information about a microarray experiment (standard for microarray data)
; mIBG: Radioactive Iodine Metaidobenzoguanidine (mIBG scans or mIBG therapy).
; MIC: Minimum Inhibitory Concentration
; ml: millilitre 0.001 liter
; MM: Malignant Melanoma
; MMR: Minor Modification Review
; MO: Medical Officer
; MOH<font> </font>: Ministry of Health (UK, Canada, others)
; MOP: Manual of Operations
; MOPH<font> </font>: Ministry of Public Health (Thailand, Yemen, others)
; mOsm: milliosmole
; MPCC: Medical Policy Coordinating Committee (CDER)
; MPNST: Malignant Peripheral Nerve Sheath Tumour
; MPR<font> </font>: Medical Products Agency (Swedish Regulatory Agency)
; MQSA: Mammography Quality Standards Act
; MR<font> </font>: Medical Representative (Japan)
; MRA: Magnetic resonance angiography
; MRA: Medical Research Associate
; MRC: [http://www.nimr.mrc.ac.uk/MRC/ Medical Research Council (UK)]
; MREC: Multi centre Research Ethics Committee (UK)
; MRgFUS: MR guided focused ultrasound
; MRI: Magnetic resonance imaging
; MRSI: Magnetic resonance spectroscopic imaging
; MRT: Malignant Rhabdoid Tumour
; MSM: Men who have Sex with Men
; MSSU: Mid stream specimen urine
; MTA: Material Transfer Agreement
; MTD: Maximum Tolerated Dose
; MTDC: Modified Total Direct Costs
; MTN: Microbicide Trials Network
; MTPCI: Multidisciplinary Training Program in Clinical Investigations
; MUD: Matched Urelated Donor  for bone marrow transplant
; MVP<font> </font>: master validation plan
; Mx: Mastectomy
; N/V: Nausea and vomiting
; NA: Not Approvable
; Na+: Sodium
; NAACCR: [http://www.naaccr.org/ North American Association of Central Cancer Registries]
; NABCO: [http://www.nabco.org/ National Alliance of Breast Cancer Organizations]
; NABR: National Association for Biomedical Research
; NABTT<font> </font>: New Approaches to Brain Tumor Therapy
; NAD: No Abnormality Detected
; NADA: New Animal Drug Application
; NAF: Notice of Adverse Findings
; NAHC: National Advisory Health Council
; NAI: No Action Indicated
; NAS: National Academy of Sciences
; NAS<font> </font>: new active substance (UK)
; NAS: National Academy of Sciences –National Research Council (U.S.)
; NBAC  NRC: National Bioethics Advisory Commission
; NBAC<font> </font>: National Bioethics Advisory Commission (U.S.)
; NBCCS: Nevoid basal cell carcinoma syndrome
; NBM: Nil by mouth
; NCA<font> </font>: national competent authority
; NCCAM: National Center for Complementary and Alternative Medicine, NIH
; NCCF: National Childhood Cancer Foundation (USA)
; NCCLS: National Committee for Clinical Laboratory Standards
; NCCTG: North Central Cancer Treatment Group
; NCE: No Cost Extension
; NCE: New Chemical Entity
; NCHS: National Center for Health Statistics
; NCI: National Cancer Institue (USA)
; NCI LSS<font> </font>: National Cancer Institute Lung Screening Study
; NCIA<font> </font>: National Cancer Imaging Archive
; NCIC: National Cancer Institute of Canada
; NCI CIRB: National Cancer Institute Central Institutional Review Board
; NCI: National Cancer Institute
; NCI PCIRB: Nat. Cancer Inst.. Pediatric Central Inst. Review Board
; NCMHD: National Center for Minority Health and Health Disparities, NIH
; NCPF: National Cancer Policy Forum
; NCRA: [http://www.ncra-usa.org/ National Cancer Registrars Association (USA)]
; NCRN: National Cancer Research Network
; NCRR: National Center for Research Resources, NIH
; NCS: Networking and Communications Subcommittee
; NCS: Not Clinically Significant
; NCTR: National Center for Toxicological Research
; NCVIA: National Childhood Vaccine Injury Act (1986)
; NDA: New Drug Application
; NDE: New Drug Evaluation
; NDS: New Drug Study
; NECCR: [http://www.ncl.ac.uk/child-health/neccr/neccr.html North of England Children's Cancer Research Unit]
; NED: No evidence of disease
; NEFARMA<font> </font>: Dutch Association of the Innovative Pharmaceutical Industry
; NEI: National Eye Institute, NIH
; NEJM: New England Journal of Medicine
; NF: National Formulary
; ng: nanogram  0.000000001 gram
; NGA: Notice of Grant Award
; NGO: Non Governmental Organization
; NHGRI: National Human Genome Research Institute, NIH
; NHI<font> </font>: National Health Insurance (Japan)
; NHIN: National Health Information Network
; NHL: Non Hodgkin's Lymphoma
; NHLBI: National Heart, Lung, and Blood Institute
; NHS<font> </font>: National Health Service (UK)
; NHVREI: NIAID HIV Vaccine Research Education Initiative
; NHW: National Health and Welfare Department (Canada's equivalent of DHHS)
; NIA: National Institute on Aging, NIH
; NIAAA: National Institute on Alcohol Abuse and Alcoholism, NIH
; NIAID: National Institute of Allergy and Infectious Diseases, NIH
; NIAID<font> </font>: National Institute of Allergies and Infectious Diseases (NIH)
; NIAMS<font> </font>: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)
; NIAMSD: National Institute of Arthritis and Musculoskeletal and Skin Diseases
; NIBIB: National Institute of Biomedical Imaging and Bioengineering, NIH
; NICHD: National Institute of Child Health and Human Development, NIH
; NICHD<font> </font>: National Institute of Child Health and Human Development (NIH)
; NIDA: National Institute of Drug Abuse, NIH
; NIDCD: National Institute on Deafness and Other Communication Disorders, NIH
; NIDCD: National Institute of Deafness and other Communication Disorders
; NIDCD<font> </font>: National Institute on Deafness and Other Communication Disorders (NIH)
; NIDCR: National Institute of Dental and Craniofacial Research, NIH
; NIDCR<font> </font>: National Institute of Dental and Craniofacial Research (NIH)
; NIDDK: National Institute of Diabetes and Digestive and Kidney Diseases, NIH
; NIDDK<font> </font>: National Institute of Diabetes and Digestive and Kidney Diseases (NIH)
; NIDDKD: National Institute of Diabetes And Digestive And Kidney Diseases
; NIDR: National Institute of Dental Research
; NIEHS: National Institute of Environmental Health Services, NIH
; NIGMS: National Institute of General Medical Sciences, NIH
; NIH: National Institutes of Health
; NIH NRSA: National Research Service Award
; NIMH: National Institute of Mental Health, NIH
; NINDS: National Institute of Neurological Disorders and Stroke, NIH
; NINR<font> </font>: National Institute of Nursing Research (NIH)
; NIOSH: National Institute for Occupational Safety and Health, CDC
; NIRB<font> </font>: noninstitutional review board, also known as an independent review board. See also Ethics Committee in the Glossary, NIRB.
; NK: Natural Killer cells (large lymphocytes, part of the immune system)
; NKA: No Known Allergies
; NKCA: [http://www.nkca.org/ National Kidney Cancer Association (USA)]
; NLEA: Nutrition Labeling and Education Act (1990)
; NLM: National Library of Medicine, NIH
; NLST: National Lung Screening Trial
; NME: New Molecular Entity
; NMR: Nuclear Magnetic Resonance
; NMSC: Non Melanoma Skin Cancer
; NNFF: [http://nf.org/ National Neurofibromatosis Foundation (USA)]
; NOAEL<font> </font>: no observed adverse effect level (IUPAC)
; NOEL: No Observed Effect Level
; Non Mem: Non linear Nixed Effect Model
; NORD: [http://www.pcnet.com/~orphan/ National Organization for Rare Disorders (USA)]
; NOS: Not otherwise specified (see ICDO)
; NPC: Nasopharyngeal Carcinoma
; NR: No Reply Necessary (COMIS term)
; NRB: noninstitutional review board, also known as an independent review board
; NRC: Nuclear Regulatory Commission
; NRC: National Research Council
; NRCT: National Registry of Childhood Tumours (UK) held by the CCRG at Oxford
; NRSA: National Research Service Award (NIH)
; NRSTS: Non Rhabdomyosarcoma Soft Tissue Sarcoma
; NSABP: National Surgical Adjuvant Breast and Bowel Project
; NSAID: Nonsteroidal Anti inflammatory Drug
; NSCLC: Non–small cell lung cancer
; NSE: Neuron Specific Enolase  a neural marker
; NSF: National Science Foundation
; NSR: Non significant result
; NSR: Nonsignificant Risk
; NTP: National Toxicology Program
; O/E: On Examination
; OAI<font> </font>: Official Action Indicated (serious FDA postinspection classification)
; OAR: Office of AIDS Research (NIH)
; OARAC: Office of AIDS Research Advisory Committee
; OASH: Office of the Assistant Secretary for Health
; OB GYN: Obstetrics Gynecology
; OC: Office of Compliance (CDER)
; OCD: Office of the Center Director (CDER)
; OCGR: Office of Communications and Government Relations (NIAID)
; OCPB: Office of Clinical Pharmacology and Biopharmaceutics (CDER)
; OD: Right Eye
; ODAC<font> </font>: Oncologic Drugs Advisory Committee (U.S.)
; ODB: Observational Database
; ODE: Office of Drug Evaluation (CDER)
; ODM: Operational Data Model (CDISC)
; OEB: Office of Epidemiology and Biostatistics (CDER)
; OECI: Organization of European Cancer Institutes
; OEHS: Office of Environmental Health and Safety
; OGA: Office of Grants and Contracts Administration
; OGD: Office of Generic Drugs (CDER)
; OHA: Office of Health Affairs
; OHITA<font> </font>: Office of Health Information Technology Adoption (ONCHIT)
; OHRM: Office of Human Resource Management
; OHRP: Office for Human Research Protections
; OIG<font> </font>: Office of the Inspector General
; OIS<font> </font>: Office of Interoperability and Standards
; OJC<font> </font>: Official Journal of the European Union–C Series (Information)
; OJEC<font> </font>: Official Journal of the European Communities
; OJL<font> </font>: Official Journal of the European Union–L Series (Legislation)
; OLAW: Office of Laboratory Animal Welfare (NIH)
; OM: Office of Management (CDER)
; OMB: Office of Management and Budget
; ONB: Olfactory Neuroblastoma
; ONCHIT<font> </font>: Office of the National Coordinator for Health Information Technology (HHS)
; ONDC: Office of New Drug Chemistry (CDER)
; ONR: Office of Naval Research
; ONS: [http://www.ons.org/ Oncology Nursing Society (USA)]
; OPCRO: Office for Policy in Clinical Research Operations
; OPERA: Office of Policy for Extramural Research Administration (NIH)
; OPR: Office of Policy and Research
; OPRR: Office of Protection for Research Risks
; OPS: Office of Pharmaceutical Science (CDER)
; ORA: Office of Regulatory Affairs
; ORAGS: Office of Research and Graduate Studies, UMB School of Medicine
; ORI: Office of Research Integrity
; ORM: Office of Review Management (CDER)
; ORO: Office of Regional Operations
; ORWH: Office of Research on Women’s Health (NIH)
; OS: Overall Survival
; OS: Left Eye
; OSHA: Occupational Safety Health Administration
; OSP: U.Va. Office of Sponsored Programs
; OTA: Office of Technology Assessment
; OTA<font> </font>: Office of Technology Assessment (U.S., abolished 1995)
; OTC: Over the Counter Drugs
; OTC: Over the counter (non prescription drugs)
; OTC: over the counter (refers to nonprescription drugs)
; OTCOM: Office of Training and Communications (CDER)
; OTR: Office of Testing and Research (CDER)
; OU: Both Eyes
; OVCR: Office of the Vice Chancellor for Research
; PA: Program Announcement (in context of funding searches)
; PAB: Pharmaceutical Affairs Branch
; PAHO<font> </font>: Pan American Health Organization
; PAIR: Patient Advocates in Research
; PAITS: Pre Approval Inspection Tracking System
; PAR: Postapproval Research
; PAVE: Partners for AIDS Vaccine Evaluation
; PBSC: Peripheral Blood Stem Cell (see PBSCT)
; PBSCH: Peripheral Blood Stem Cell Harvest
; PBSCR: Peripheral Blood Stem Cell Rescue (transplant)
; PBSCT: Peripheral Blood Stem Cell Transplant
; PBTC<font>  </font>: Pedi Brain Tumor Consortium
; PC: Personal Computer
; PCC: Parklawn Computer Center
; PCC: Poison Control Center
; PCP: Pneumocystis carinii pneumonia
; PCR: Polymerase Chain Reaction
; PD: Progressive disease
; PD: Pharmacodynamics
; PDA: Parenteral Drug Association
; PDA<font> </font>: personal digital assistant (Palm Pilot, for example)
; PDC: Protocol Development Coordinator
; PDF<font> </font>: portable document format
; PDQ: Physician's Data Query (CancerNet)
; PDR: Physician's Desk Reference
; PDRC: Protocol Development and Regulatory Compliance
; PDUFA: Prescription Drug User Fee Act of 1992
; PE: Physical Examination
; PEM<font> </font>: prescription event monitoring
; PEP: Performance Evaluation Plan
; PERI: Pharmaceutical Education & Research Institute (not for profit division of PhRMA)
; PET: Positron Emmission Tomography  a scan after a small radioactive injection.
; PFS: Progression Free Survival
; PFT: Pulmonary Function Tests
; PFT<font> </font>: pulmonary function test
; pg: picogram  0.000000000001 gram
; PGT<font> </font>: pharmacogenetics
; PGX<font> </font>: pharmacogenomics
; pH: hydrogen ion concentration  acid / alkaline
; Phase I trial: A clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed.
; Phase II trial: A clinical trial in which the safety and preliminary efficacy of an intervention are assessed.
; Phase III trial: A large scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market.
; Phase IV trial: A large scale trial undertaken after FDA approval for safety surveillance to detect rare or long term adverse events. Also known as a post marketing surveillance trial.
; PHI: Protected health information
; PHI: Protected Health Information
; PHI: Protected Health Information
; PhPID<font>  </font>: pharmaceutical product identifier
; PhRMA: Pharmaceutical Research and Manufacturers of America
; PhRMA<font> </font>: Pharmaceutical Research and Manufacturers of America
; PHRP: Partnership for Human Research Protection, Inc.
; PHS: Public Health Service
; PHS: Public Health Service
; PHS2590: Refers to the form used for noncompeting continuation applications to the NIH
; PHS398: Refers to the form used for new and competing renewal applications to the NIH
; PI: Principal Investigator
; PI: Package Insert (approved product labeling)
; PIM: product information management (a system introduced by the EMEA)
; PK: Pharmacokinetics
; PLA: Patent License Agreement
; PLA: Product License Application (when seeking commercialization of a biologic)
; PLA/ELA: Product License Application/Establishment License Application
; PLWA: Person Living With AIDS
; PM: Project Manager
; PMA: Pre Market Approval (when seeking commercialization of a device)
; PMCC: Project Management Coordinating Committee (CDER)
; PMDIT: Project Management
; PMS: Postmarketing Surveillance
; PN: Protocol Amendment  New Protocol (or Pending Review) (COMIS term)
; PNET: Primitive neuroectodermal tumour <font>Context: </font><font>CNS tumours</font>
; PNS: Peripheral nervous system  nervous system outside the brain and spine.
; PO: Purchase Order
; PO: Per Os (by mouth)
; POG: Pediatric Oncology Group (USA)
; PONF: Paediatric Oncology Nurses Forum (UK)
; PPA: Poison Prevention Act
; PPE: Personal Protective Equipment
; PPI: Patient Package Insert
; PPO: Policy and Procedure Order
; PPO: Preferred Provider Organization
; PR: Partial Responce / Partial Remission
; PR: Pulse Rate
; PRC: Protocol Review Committee  U.Va. Cancer Center
; PRG: Protocol Representation Group (CDISC)
; PRIM & R: Public Responsibility in Medicine and Research
; prn: as required
; PRN: As Needed
; PRO: patient reported outcome
; Process map: A visual representation of a workflow comprising a stream of activities that transforms a well defined input or set of inputs into a pre defined set of outputs.
; PROG: Peer Review Oversight Group (NIH)
; PROMIS<font> </font>: Patient Reported Outcomes Measurement Information Systems (pronounced promise)
; Protocol: A study plan on which a clinical trial is based. The plan is designed to safeguard the health of participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
; PRT: Primary Review Team
; PSA: Protocol specific Application
; PSRC: Prevention Sciences Review Committee
; PSUR<font>  </font>: periodic safety update report
; PTAO/PTAEO: Project Task Award Office
; PTC<font>  </font>: points to consider
; PTCC: Pharmacology/Toxicology Coordinating Committee (CDER)
; PTN: (see HPTN)
; PTV: Primary tumor volume
; PV<font> </font>: pharmacovigilance
; PWA: Person With AIDS
; QA: Quality Assurance
; QALY: Quality Adjusted Life Year
; QARC: Quality Assurance Review Center
; QAU: Quality Assurance Unit
; QC: Quality Control
; QD: Once Daily
; qid: Four times a day (quater in die)
; QL: Quality of Life
; QNS: Quantity Not Sufficient
; QOD: Every Other Day
; QoL: Quality of Life
; QOL: quality of life (also QoL)
; R & D: Research and Development
; RA<font> </font>: Research Associate
; RAB: Regulatory Affairs Branch (DAIDS)
; RAC: Reviewer Affairs Committee (CDER)
; RADAR: Risk Assessment of Drugs  Analysis and Response
; RAPS: Regulatory Affairs Professionals Society
; RBC: Red blood cell / red blood count
; RC: Research Coordinator
; RCC: Research Coordinating Committee (CDER)
; RCC: Regulatory Compliance Center (DAIDS)
; RCH: Remove Clinical Hold
; RCR: Responsible Conduct of Research
; RCRA: Regional Clinical Research Associate
; RCRIM<font> </font>: Regulated Clinical Research Information Management, a technical committee of HL7 with responsibility for developing technical standards for the exchange and management of health research information to be submitted to regulatory authority(ies)
; RCT: Randomized Clinical Trial
; RD: Response to Request for Information (COMIS term)
; RDE: Remote Data Entry
; RDRC: Radioactive Drug Research Committee
; RDT: Rising dose tolerance
; REB<font> </font>: research ethics board (Canada)
; REMS<font> </font>: Risk Evaluation and Mitigation Strategy (FDA, in FDAAA)
; RFA: Radiofrequency ablation
; RFD<font> </font>: retrieve form for data capture
; RFP: Request for Proposals (Contracts)
; RFQ: Request for Quote
; RHIO<font> </font>: regional health information organization
; RIF: Reduction In Force
; RIGS: Radioimmunoguided surgery
; RIM<font> </font>: Reference Information Model (HL7)
; RKI: Robert Koch Institut, Bundesinstitut für Infektionskrankheiten und nich übertragbare Krankheiten (Federal Institute for Infectious and Noncommunicable Diseases, Germany)
; RL: Regulatory Letter
; RMO: Regulatory Management Officer
; RMS: Rhabdomyosarcoma
; RMW: Regulated Medical Waste
; ROC: Receiver operating characteristic
; ROE: Report of Expenditures
; RPE: Radiation Producing Equipment
; RPS: Regulated Product Submission (HL7 RCRIM)
; RSC: Radiation Safety Committee
; RSO: Radiation Safety Officer
; RT: Radiotherapy
; RTF: Refuse To File
; RTOG: Radiation Therapy Oncology Group
; RTPCR: Reverse transcriptase polymerase chain reaction
; RUG: Resource Utilization Group
; Rx: Treatment
; S: Standard
; SA: Surface area (see BSA)
; SAAVI: South African AIDS Vaccine Initiative
; SACHRP<font> </font>: Secretary's Advisory Committee on Human Protection. See also OHRP .
; SADR<font> </font>: suspected adverse drug reaction (FDA)
; SAE: Serious adverse event
; SAG: Science Administration Group
; SAL: Sterility Assurance Level
; SAS<font> </font>: Statistical Analysis System (commonly used statistical analysis package)
; SATCM<font> </font>: State Administration of Traditional Chinese Medicine (China)
; SBA: Summary Basis of Approval
; SBIR: Small Business Innovation Research Grant
; SBS IRB: Social and Behavioral Sciences Institutional Review Board
; SC: Subcutaneous
; SC: Study Coordinator
; SCAW: Scientists Center for Animal Welfare
; SCDM<font>  </font>: Society for Clinical Data Management
; SCHARP: Statistical Center for HIV AIDS Research and Prevention
; SCLC: Small cell lung cancer
; SCSO: Supervisory Consumer Safety Officer
; SCT<font> </font>: Society for Clinical Trials
; SCTN: Scottish Cancer Therapy Network
; SD: Stable Disease
; SD: Standard Deviation
; SD: Source Document
; SDA<font>  </font>: State Drug Administration (China)
; SDM<font> </font>: Submission Data Model (CDISC)
; SDMC: Statistical and Data Management Center
; SDO<font> </font>: standards development organization
; SDS<font> </font>: Submission Data Standards (CDISC)
; SDTM<font> </font>: Study Data Tabulation Model (CDISC)
; SDV: Source Data Verification
; SDV<font> </font>: source document (data) verification
; SE: Standard Error
; SE<font> </font>: standard error (statistics)
; SEA<font>  </font>: Single European Act of 1987
; SEER: Surveillance, Epidemiology, and End Results (Registry of NCI)
; SEG: Special Emphasis Group (Laboratory)
; SEND<font> </font>: Standard for the Exchange of Nonclinical Data. NOTE: The focus of the SEND Team is on data collected from animal toxicology studies. [CDISC]
; SES: Senior Executive Service
; SF: Standard Form (Federal)
; SFOP: French Paediatric Oncology Scociety
; SGDM: Study Group on Data Management (EORTC)
; SGML: Standard Generalized Markup Language
; SGO: [http://www.sgo.org/ Society of Gynecologic Oncologists]
; SGOT: Serum glutamic oxalacetic transaminase  a liver function test
; SGPT: Serum glutamic pyruvic transaminase  a liver function test
; SHIV: Simian Human Immunodeficiency Virus
; SHO: Senior House Officer
; SIAC<font> </font>: Special Interest Area Community (DIA)
; SIG<font> </font>: Special Interest Group (HL7)
; SIOP: International Society of Paediatric Oncology
; SIV: Simian Immunodeficiency Virus
; SLA<font>  </font>: service level agreement
; SMART: Submission Management and Review Tracking
; SMDA: Safe Medical Devices Act (1990)
; SME: Significant Medical Event
; SMO: Site Management Organization
; SmPC<font> </font>: summary of product characteristics. See also SPC.
; SNAP: Streamlined Noncompeting Award Process (NIH)
; SNDA: Supplemental New Drug Application
; SNIP<font> </font>: Syndicat National de l'Industrie Pharmaceutique (France)
; SNLG: Scottish and Newcastle Lymphoma Group
; SNOMED<font> </font>: Systematized Nomenclature of Medicine (a dictionary)
; SNP: Single Nucleotide Polymorphism
; SOAP<font> </font>: simple object access protocol (a W3C XML initiative)
; SOB: Short of breath
; SoCRA: Society of Clinical Research Associates
; SOM: School of Medicine
; SOMCTO: School of Medicine Clinical Trials Office
; SOMOGC: School of Medicine Office of Grants and Contracts Administration
; SON: School of Nursing
; SOP: Standard operating procedure
; SOW: Scope of Work
; SPAC<font> </font>: State Pharmaceutical Administration of China
; SPC<font> </font>: summary of product characteristics. See also SmPC.
; SPL<font> </font>: Structured Product Labeling (HL7, FDA)
; SPM<font> </font>: Society of Pharmaceutical Medicine (UK)
; SPOHNC: [http://www.spohnc.org/ Support for People with Oral and Head and Neck Cancer]
; SPORE: Specialized Programs of Research Excellence
; SQ: Subcutaneous
; SQA<font> </font>: Society of Quality Assurance
; SQAP: systems quality assurance plan
; SRA: Society of Research Administrators
; SRA: Staff Research Associate
; SRS: Spontaneous Reporting System
; SSC: Scientific Steering Committee (HVTN)
; SSC<font> </font>: study site coordinator. See also CRC, CCRC, SC.
; SSCT<font> </font>: Swedish Society for Clinical Trials
; SSFA<font> </font>: Società di Scienze Farmacologiche Applicate (Italy)
; SSM: Superficial Spreading Melanoma
; SSM: Skin Surface Microscopy
; STD: Sexually Transmitted Disease
; STF: study tagging file
; STI: Sexually Transmitted Infection
; STT: Short Term Tests
; STTR: Small Business Technology Transfer Grant
; SUAE<font> </font>: serious unexpected adverse event
; SUD<font> </font>: sudden unexpected death
; SUPAC: Scale up and post approval changes
; SWG: Strategic Working Group
; SWOG: Southwest Oncology Group
; SX: Symptoms
; TAC: Technical Advisory Committee (CDISC)
; TAMs: tumour associated macrophages
; TBI: Total body irradiation
; TC<font> </font>: Technical Committee (HL7)
; TCC: Transitional Cell Carcinoma (usually bladder cancer)
; TCP: Thrombocytopenia
; TCP/IP<font>  </font>: Transmission Control Protocol/Internet Protocol
; TDC: Total Direct Costs
; tds / tid: Three times a day (ter in die)
; TESS: treatment emergent signs and symptoms
; TID: Three Times A Day
; TIND: Treatment IND
; TK: Toxicokinetics
; Tmax<font> </font>: the time after dosing when Cmax occurs
; TMO<font> </font>: trial management organization
; TNF: Tumour Necrosis Factor
; TNM: Staging system  primary tumour
; TOP: Topical
; TPN: total parenteral nutrition
; TRK: Transketolase
; TSH: Thyroid Stimulating Hormone
; UA: Urinalysis
; ug: microgram  0.000001 gram
; UICC: [http://www.uicc.org/ Union Internationale Contre le Cancer  International Union Against Cancer]
; UKACR: UK Association of Cancer Registeries
; UKCCCR: UK Coordinating Committee for Cancer Research
; UKCCR: United Kingdom Coordinating Committee on Cancer Research
; UKCCRG: [http://www.ccrg.ox.ac.uk/ UK Children's Cancer Research Group (Oxford)]
; UKCCSG: [http://www.ukccsg.org/ UK Children's Cancer Study Group (UK)]
; ULN: Upper Limits of Normal
; UMMS: University of Maryland Medical System
; UMT<font> </font>: universal mean time (also known as Greenwich mean time). See UTC.
; UNAIDS: Joint United Nations Programme on HIV/AIDS
; UNESCO: United Nations Educational Science and Cultural Organization
; UNK: Unknown
; URL<font>  </font>: uniform resource locator (address of a Web site)
; URTI: Upper respiratory tract infection
; US: Ultrasound (scan)
; USAN: United States Adopted Name
; USDA: United States Department of Agriculture
; USMHRP: U.S. Military HIV Research Project
; USP: U.S. Pharmacopeia
; USPC: U.S. Pharmacopeial Convention
; USP DI: United States Pharmacopeia Drug Information
; USPIO: Ultrasmall particle superparamagnetic iron oxide
; USP NF: United States Pharmacopeia National Formulary
; UST<font> </font>: user site testing. Synonym for UAT (user acceptance testing)
; USUHS: Uniformed Services University of the Health Sciences
; UTI: Urinary Tract Infection
; UVR: Ultra Violet Radiation
; VA: Department of Veteran’s Affairs (Federal)
; VAERS: Vaccine Adverse Event Reporting System
; VAI: Voluntary Action Indicated
; VAI: Voluntary Action Indicated (FDA postaudit inspection classification)
; VAI: Voluntary Action Indicated (post FDA audit inspection classification)
; Value stream mapping: a lean process visualization technique used to analyze the flow of materials and information through a system. The goal of value stream mapping is to understand and streamline the work processes by reducing waste, or activities that do not add value.
; VCDE<font> </font>: vocabularies and common data elements (caBIG)
; VDGIF: Virginia Dept. of Game and Inland Fisheries
; VEF: Ventricular ejection fraction (tests lung function)
; VGDS<font>  </font>: voluntary genomic data submission
; VIEW <font>                  </font>: Virtual Imaging Evaluation Workspace
; VM 26: Teniposide (anti cancer drug)
; VMA: Vanillylmandelic Acid
; VP 16: Etoposide (anti cancer drug)
; VPRP: Vaccine and Prevention Research Program (DAIDS)
; VRC: Dale and Betty Bumpers Vaccine Research Center (NIAID/NIH)
; VS: Vital Signs
; VTN: (see HVTN)
; WBC: White blood cell count
; WCC: White cell count
; WD: Withdrawn (COMIS term)
; WHO: World Health Organization
; WHOART<font> </font>: World Health Organization Adverse Reaction Terminology
; WI: Inactive (COMIS term)
; WIHS: Women's Interagency HIV Study (DAIDS)
; WITS: Women and Infants Transmission Study (DAIDS)
; WL<font>  </font>: Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days)
; WNL: Within Normal Limits
; WOCBP: Women of Child Bearing Potential
; WR<font> </font>: written request
; WRAIR: Walter Reed Army Institute of Research
; WTO<font> </font>: World Trade Organization
; WVA: World Veterinary Association
; WWW <font> </font>: World Wide Web
; XIP<font> </font>: EXtensible Imaging Platform
; XML<font>  </font>: eXtensible Markup Language
; XRT: Radiotherapy (external)
; YST: Yolk sac tumour  (aka. germ cell tumour)


==F==
{{WS}}
FAQ frequently asked
questions
Farmindustria The Association
of Italian Pharmaceutical
Manufacturers
FD&C Act Food, Drug, and
Cosmetic Act (U.S.)
FDA Food and Drug Administration
(U.S.)
FDAMA FDA Modernization Act
FDLI Food and Drug Law
Institute
FFPM Fellow of the Faculty of
Pharmaceutical Medicine (UK)
FRCP Fellow of the Royal
College of Physicians, sometimes
followed by a place
name—for example, FRCP
(Edin.)—that indicates a
university medical school
FTC Federal Trade
Commission (U.S.)
FTP File Transfer Protocol
FWA Federal-wide assurance
 
 
==G==
GAO General Accounting
Office (U.S. government)
GBP good business practice
Gbps gigabits or billions of
bits per second (data transmission)
GCP good clinical practice
GCRP good clinical research
practice
GLP good laboratory practice
GMP good manufacturing
practice
GP general practitioner;
general practice (UK)
GPMS good postmarketing
surveillance practice (Japan)
GRAS generally regarded as
safe (foods)
GXP good [pharmaceutical]
practice
HCFA Health Care Financing
Administration; now renamed
The Centers for Medicare &
Medicaid Services.
HEX human experimentation
committee. See also Ethics
Committee box.
HHS Department of Health
and Human Services (U.S.,
also called DHHS)
HIMA Health Industry
Manufacturers Association
HIMSS Health Information
and Management Systems
Society
HIPPA Health Insurance Portability
and Accountability Act
HL7 Health Level 7 (a not-forprofit
ANSI-accredited standards
developing organization
(SDO)
HPB Health Protection
Branch, Laboratory Centre for
Disease Control (Canada)
HPLC high performance liquid
chromatography
HSRC human subjects review
committee. See also Ethics
Committee box.
HTML Hypertext Markup
Language
HTTP Hypertext Transfer
Protocol
I3C India CDISC Coordinating
Committee
IAB Industry Advisory Board
(for CDISC)
IB investigator’s brochure
IC informed consent
ICD9 International
Classification of Diseases,
9th revision. See also MedDRA.
ICG India CDISC Group
ICH International Conference
on Harmonisation of Technical
Requirements for Registration
of Pharmaceuticals for
Human Use
ICR Institute of Clinical
Research (formerly ACRPI,
Association for Clinical
Research in the
Pharmaceutical Industry, UK)
ICSR individual case safety
report
ICTH International Committee
on Thrombosis and
Haemostases
IEC independent ethics
committee. See also Ethics
Committee box.
IEEE Institute of Electrical
and Electronic Engineers, Inc.
IFAPP International Federation
of Associations of
Pharmaceutical Physicians
IFPMA International
Federation of Pharmaceutical
Manufacturers’ Associations
IG Inspector General (HHS)
IKS Interkantonale
Kontrollstelle für Heilmittel
(Switzerland)
IMP investigational materials
plan
IND Investigational New Drug
application (FDA). See also
TIND
IOM Institute of Medicine
(National Academy of
Science, U.S.)
IPRO independent
pharmaceutical research
organization. See also CRO
IRB institutional review
board; independent review
board. See also Ethics
Committee box.
IRD International Registration
Document
ISCB International Society for
Clinical Biostatistics
ISDN Integrated Services
Digital Network
ISO International Organization
for Standardization
ISP Internet service provider
IT information technology
ITU-T Telecommunication
Standardization Sector of the
International Telecommunications
Union
IVD in vitro diagnostics
IVR interactive voice
response (telephone
technology)
IVRS interactive voice
response system
J3C Japan CDISC
Coordinating Committee
JCAHO Joint Commission on
Accreditation of Healthcare
Organizations
JCG Japan CDISC Group
JMA Japan Medical
Association
JPMA Japan Pharmaceutical
Manufacturers Association
Kbps kilobits or thousands of
bits per second (data
transmission)
LAB Laboratory Data Model
(CDISC)
LAN local area network
LIF Swedish Pharmaceutical
Industry Association
LKP Leiter der klinischen
Prüfung
LOA letter of agreement
LREC local research ethics
committee (UK). See also
Ethics Committee box.
MA marketing authorization
MAA Marketing application
(EU)
Mbps millions of bits per
second (data transmission)
MCA Medicines Control
Agency (UK)
MDR Medical Device
Reporting
MedDRA Medical Dictionary
for Regulatory Activities (new
global standard medical
terminology designed to
supersede other terminologies
used in the medical
product development
process, including COSTART,
ICD9, and others)
MEDLARS Medical Literature
Analysis and Retrieval System
MEFA Association of the Danish
Pharmaceutical Industry
MEP Member of the European
Parliament
MHLW Ministry of Health,
Labor and Welfare (Japan)
MIAME minimum information
about a microarray experiment
(standard for microarray
data)
MOH Ministry of Health (UK,
Canada, others)
MOPH Ministry of Public
Health
MOU Memorandum of
Understanding (an MOU
between FDA and a regulatory
agency in another country
allows mutual recognition of
inspections)
December 2003 actmagazine.com APPLIED CLINICAL TRIALS 29
MR medical representative
(Japan)
MRA medical research
associate
MREC multicentre research
ethics committee(UK). See
also Ethics Committee box.
MRI magnetic resonance
imaging
MTD maximum tolerated dose
MVP master validation plan
NABR National Association
for Biomedical Research
NAF Notice of Adverse Findings
(FDA postaudit letter)
NAI No Action Indicated
(most favorable FDA postinspection
classification)
NAS new active substance
(UK)
NAS–NRC National Academy
of Sciences–National
Research Council (U.S.)
NBAC National Bioethics
Advisory Commission (U.S.)
NCCAM National Center for
Complementary and Alternative
Medicine, formerly Office
of Alternative Medicine (NIH)
NCCTG North Central Cancer
Treatment Group (U.S.)
NCDM Nordic Clinical Data
Management (Association)
NCE new chemical entity
NCHGR National Center for
Human Genome Research
(NIH)
NCHS National Center for
Health Statistics (in CDC)
NCI National Cancer Institute
(NIH)
NCPDP National Council for
Prescription Drug Programs
NCPIE National Council on
Patient Information and
Education (Washington, DC)
NCR no carbon [paper]
required
NCRR National Center for
Research Resources (NIH)
NCVIA National Childhood
Vaccine Injury Act (1986)
NDA New Drug Application
(FDA)
NDS New Drug Submission
(Canada’s new drug
application)
NEFARMA Dutch Association
of the Innovative Pharmaceutical
Industry
NEI National Eye Institute
(NIH)
NGO nongovernmental
organization
NHI National Health
Insurance (Japan)
NHLBI National Heart, Lung,
and Blood Institute (NIH)
NHS National Health Service
(UK)
NIA National Institute on
Aging (NIH)
NIAAA National Institute on
Alcohol Abuse and Alcoholism
(NIH)
NIAID National Institute of
Allergies and Infectious
Diseases (NIH)
NIAMS National Institute of
Arthritis and Musculoskeletal
and Skin Diseases (NIH)
NICHD National Institute of
Child Health and Human
Development (NIH)
NIDA National Institute on
Drug Abuse (NIH)
NIDCD National Institute on
Deafness and Other Communication
Disorders (NIH)
NIDDK National Institute of
Diabetes and Digestive and
Kidney Diseases (NIH)
NIDR National Institute of
Dental Research (NIH)
NIEHS National Institute of
Environmental Health
Sciences (NIH)
NIGMS National Institute of
General Medical Sciences
(NIH)
NIH National Institutes of
Health (DHHS)
NIMH National Institute of
Mental Health (NIH)
NINDS National Institute of
Neurological Disorders &
Stroke (NIH)
NINR National Institute of
Nursing Research (NIH)
NIRB noninstitutional review
board. See also Ethics
Committee box.
NLM National Library of
Medicine (NIH)
NME new molecular entity
NOEL No observable effect
level [dose of an experimental
drug given pre-clinically, that
does not produce an observable
toxicity]
NRB noninstitutional review
board, also known as an independent
review board. See
also Ethics Committee box.
NSCLC non-small cell lung
carcinoma
NTP National Toxicology Program
OAI Official action indicated
(serious FDA post-inspection
classification)
OAM See NCCAM
ODAC Oncologic Drugs
Advisory Committee (U.S.)
ODE Office of Drug Evaluation
(CDER now has five such
offices: ODE I, II, III, IV, and V)
ODM Operational Data Model
[CDISC]
OGD Office of Generic Drugs
(CDER, formerly DGB)
OGE Office of Government
Ethics (formerly part of Office
of Personnel Management,
separate executive branch in
1989)
OHRP Office for Human
Research Protections
OIG Office of the Inspector
General
OJC Office Journal of the
European Union–C Series
(Information)
OJEC Official Journal of the
European Communities
OJL Office Journal of the
European Union–L Series
(Legislation)
OMB Office of Management
and Budget (U.S.)
OPRR Office for Protection
from Research Risks
(predecessor to OHRP)
OSHA Occupational Safety
Health Administration (U.S.)
OTA Office of Technology
Assessment (U.S.; abolished
by Congress, Fall 1995)
OTC over-the-counter (refers
to nonprescription drugs)
PAB Pharmaceutical Affairs
Bureau (Japan)
PAHO Pan American Health
Organization
30 APPLIED CLINICAL TRIALS actmagazine.com December 2003
PCC Poison Control Center
PCP Pneumocystis carinii
pneumonia
PD pharmacodynamics
PDA personal digital assistant
(Palm Pilot, for example)
PDF Portable Document
Format
PDQ Physicians’ Data Query
(NCI-sponsored cancer trial
registry)
PDR Physicians’ Desk Reference
PDUFA Prescription Drug User
Fee Act (1992, U.S.)
PEM prescription event
monitoring
PERI Pharmaceutical Education
& Research Institute (notfor-
profit division of PhRMA)
PFT pulmonary function tests
PhRMA Pharmaceutical
Research and Manufacturers
of America (formerly PMA)
PHS Public Health Service
(U.S.)
PI principal investigator
PK pharmacokinetics
PKI public key infrastructure
PLA Product License
Application (FDA)
PMA Pre-Market Approval
application (FDA)
PMS postmarketing surveillance
PPI patient package insert
PPO preferred provider
organization; policy and
procedure order
PR partial response; pulse
rate
PRIM&R Public Responsibility
in Medicine and Research
(Boston, MA)
PROG peer-review oversight
group (NIH)
PSUR periodic safety update
report
PTC Points to Consider
QA quality assurance
QAU quality assurance unit
QC quality control
QL quality of life
QOL quality of life
R&D research and
development
RADAR Risk Assessment of
Drugs—Analysis and
Response
RAPS Regulatory Affairs
Professionals Society
RCRIM Regulated Clinical
Research and Information
Management (HL7)
RCT randomized clinical trial
RDE remote data entry
RDRC Radioactive Drug
Research Committee
REB research ethics board
(Canada)
RIM Reference Information
Model (HL7)
RKI Robert-Koch-Institut,
Bundesinstitut für Infektionskrankheiten
und nich-übertragbare
Krankheiten (Federal
Institute for Infectious and
Non-communicable Diseases,
Germany)
RL regulatory letter (FDA postaudit
letter)
SAE serious adverse event
SAS Statistical Analysis
System (commonly used
statistical analysis package)
SATCM State Administration
of Traditional Chinese
Medicine (China)
SBA summary basis of
approval
SC study coordinator. See also
CRC, CCRC, SSC
SCDM Society for Clinical
Data Management (US)
SCT Society for Clinical Trials
SD standard deviation
SDA State Drug
Administration (China)
SDM Submission Data Model
(CDISC)
SDO standards development
organization
SDS Submission Domain
Standards (CDISC)
SDS submissions data
standard
SE standard error (statistics)
SEA Single European Act of
1987
SEER Surveillance, Epidemiology,
and End Results program
of the the National Cancer
Institute that collects and
publishes cancer incidence
and survival data.
SGML Standard Generalized
Markup Language
SIAC Special Interest Area
Community (DIA)
SIG Special Interest Group
(HL7)
SLA service level agreement
SMART Submission
Management and Review
Tracking (FDA)
SME significant medical event
SMO site management
organization
SmPC Summary of Product
Characteristics
SNDA Supplemental New
Drug Application
SNIP Syndicat National de
l’Industrie Pharmaceutique
(France)
SNOMED Systematized
Nomenclature of Medicine (a
dictionary)
SOCRA Society of Clinical
Research Associates
SOP standard operating
procedure
SPAC State Pharmaceutical
Administration of China
SPM Society of Pharmaceutical
Medicine (UK)
SQA Society of Quality
Assurance
SQAP systems quality
assurance plan
SSC study site coordinator.
See also CRC, CCRC, SC
SSCT Swedish Society for
Clinical Trials
SSFA Società di Scienze Farmacologiche
Applicate (Italy)
STF study tagging file
STT short term tests
SC study coordinator. See
clinical research coordinator.
SUA serious unexpected
adverse event
SUD sudden unexpected
death
SWOG Southwest Oncology
Group (U.S.)
December 2003 actmagazine.com APPLIED CLINICAL TRIALS 31
TC Technical Committee
(HL7)
TCC Technical Coordinating
Committee (CDISC)
TCP/IP Transmission Control
Protocol/Internet Protocol
TESS treatment emergent
signs and symptoms
TIND Treatment IND. See also
IND
TK toxicokinetics
Tmax the time after dosing
when Cmax occurs
TMO trial management
organization
URL uniform resource locator
(address of a Web site)
USC United States Code
(book of laws)
USDA Department of
Agriculture (U.S.)
USP United States
Pharmacopeia
VA Veterans Administration
(officially, United States
Department of Veterans
Affairs)
VAERS Vaccine Adverse Event
Reporting System
VAI Voluntary Action Indicated
(FDA postaudit inspection
classification)
VGDS Voluntary Genomic
Data Submission
VPN virtual private network
WAN wide area network
WHO World Health
Organization
WHOART World Health
Organization Adverse
Reaction Terminology
WL Warning Letter (most
serious FDA postaudit letter,
demands immediate action
within 15 days)
WRAIR Walter Reed Army
Institute of Research (DoD)
WTO World Trade Organization
www World Wide Web
XML Extensible Markup
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


For acronyms of clinical trial names, click here

AA
Anaplastic Anaemia
AAALAC
Association for Assessment and Accreditation of Laboratory Animal Care
AAALAC
Assoc. for Assessment and Accreditation of Laboratory Animal Care International
AAAS
American Association for the Advancement of Science
AABB
American Association of Blood Banks
AACR
American Association for Cancer Research
AACR
American Association for Cancer Research
AADA
Abbreviated Antibiotic Drug Application
AAFP
American Academy of Family Physicians
AAHRPP
.
AAI
American Academy of Immunologists
AALAS
American Assoc. for Laboratory Animal Science
AAMC
Association of American Medical Colleges
AAP
American Association of Pathologists
AAPS
American Association of Pharmaceutical Scientists
ABC
Advanced Breast Cancer
ABMT
Autologous bone marrow transplant
ABPI
Association of the British Pharmaceutical Industry
ABSL
Animal Biosafety Level
ABTA
American Brain Tumour Association
ACCP
American College of Clinical Pharmacology
Accrual
the enrollment of qualified patients into clinical trials.
Accrue
to enroll qualified patients into clinical trials.
ACDM
Association for Clinical Data Management
ACE
Adverse Clinical Event
ACIL
American Council of Independent Laboratories
ACIL
A national trade association representing independent, commercial scientific, and engineering firms
ACLAM
American College of Laboratory Animal Medicine
ACNP
American College of Nuclear Physicians
ACOR
Association of Cancer Online Resources
ACOSOG
American College of Surgeons Oncology Group
ACP
Associates of Clinical Pharmacology
ACPU
Association of Clinical Pharmacology Units
ACR
American College of Radiology
ACRA
Associate Commissioner of Regulatory Affairs
ACRP
Association of Clinical Research Professionals
ACRPI
Association of Clinical Research for the Pharmaceutical Industry
ACRPI
Changed its name to Institute of Clinical Research (UK)
ACS
American Cancer Society
ACS
American Chemical Society
ACT
Applied Clinical Trials
ACTG
AIDS Clinical Trials Group (DAIDS)
ACTG
AIDS Clinical Trials Group (NIAID)
ACTU
AIDS Clinical Trials Unit (NIH)
ACT UP
AIDS Coalition to Unleash Power
ACUC
Animal Care and Use Committee
ADaM
Analysis Data Model (a CDISC standard)
ADaM
Analysis Dataset Model (CDISC)
ADAMHA
Alcohol, Drug Abuse and Mental Health Administration
ADE
Adverse Drug Event
ADI
Acceptable Daily Intake
Adjuvant therapy
medical treatment given in addition to a primary treatment. In the case of cancer, this can be chemotherapy, radiation, or hormone therapy given in addition to surgical removal of a tumor, for example. Adjuvant therapies are used to enhance the effect of primary treatment, and would not necessarily be expected to have therapeutic effect in the absence of the primary treatment.
ADME
Absorption, Distribution, Metabolism and Excretion
ADP
Automated Data Processing
ADR
Adverse Drug Reaction
ADRS
Adverse Drug Reporting System
AE
Adverse Event (any negative or unwanted effect from a drug, device, or medical test).
AEGIS
ADROIT Electronically Generated Information Service, a subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency’s ADROIT (Adverse Drug Reaction On line Information Tracking) database.
AERS
Adverse Event Reporting System (FDA)
AFCR
American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)
AFDO
Association of Food and Drug Officials
AFMR
American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)
AFP
Alphafetoprotein eg. expressed by germ cell tumours and other cancers
AHA
American Heart Association
AHCPR
Agency for Health Care Policy and Research
AHCPR
Agency for Health Care Policy Research (NIH)
AHRQ
Agency for Healthcare Research and Quality
AICRC
Association of Independent Clinical Research Contractors (UK)
AIDS
Acquired immune deficiency syndrome
AIG
Active Ingredient Group
AIM
Active Ingredient Manufacturer
AIOM
Italian Association for Medical Oncology
AIP
Abbreviated Inspection Program
AIRO
Associazione Italiana di Radioterapia Oncologica
AIUM
American Institute of Ultrasound in Medicine
AJCC
American Joint Committee on Cancer
ALARA
As Low As Reasonably Achieved
ALAT
Alanine aminotransferase / alinine transaminase
ALCL
Anaplastic Large cell Lymphoma
ALCOA
attributable, legible, contemporaneous, original, accurate (dimensions of data quality)
ALL
Acute lymphoblastic leukaemia
ALT
Alanine Aminotransferase
am
ante meridian, morning (12:00 midnight thru 11:59:59)
AMA
American Medical Association
AMA DE
AMA Drug Evaluations
AMC
Antibody mediated cytotoxicity
AMF
Administrative Management of the Files
AmFAR
American Foundation for AIDS Research
AMG
West Germany Drug Law
AMKL
acute megakaryocytic leukemia
AML
Acute Myeloid leukemia
AMWA
American Medical Writers Association
ANADA
Abbreviated New Animal Drug Application
ANC
Absolute neutrophil count
ANDA
Abbreviated New Drug Application (for a generic drug)
ANED
Alive no evidence of disease
ANLL
Acute non lymphatic leukaemia
ANOVA
Analysis of variance
ANSI
American National Standards Institute
AO
Administrative Official
AOAC
Association of Official Analytical Chemists
AOAC
Association of Official Analytical Chemists
APB
Association Pharmaceutique Belge (Belgium)
APhA
American Pharmaceutical Association
APHIS
Animal and Plant Health Inspection Service
APHIS
Animal and Plant Health Inspection Service (USDA)
API
active pharmaceutical ingredient
APPI
Academy of Pharmaceutical Physicians and Investigators
AQL
Acceptable Quality Level
ARCS
Association of Regulatory & Clinical Scientists (Australia)
ARENA
Applied Research Ethics National Association
ARMS
Alveolar rhabdomyosarcoma
ARO
academic research organization
ART
Antiretroviral Therapy
ASA
American Statistical Association
ASAP
administrative systems automation project (FDA)
ASCII
American Standard Code for Information Interchange (computer files)
ASCO
American Society of Clinical Oncology
ASCPT
American Society for Clinical Pharmacology and Therapeutics
ASCPT
American Society for Clinical Pharmacology and Therapeutics
ASH
American Society for Hematology
ASM
American Society for Microbiology
ASO
AIDS Service Organization
ASQ
American Society for Quality, formerly American Society for Quality Control
ASR
Age Standardised Rate (Incidence)
ASTRO
American Society for Therapeutic Radiology and Oncology
AT
Active (COMIS term)
ATC
Anatomic Therapeutic Chemical Coding dictionary
ATF
Bureau of Alcohol, Tobacco, and Firearms
AU
Authorized User
AUC
Area Under the Curve (an expression of exposure)
AV
Attending Veterinarian
AVAC
AIDS Vaccine Advocacy Coalition
AVEG
AIDS Vaccine Evaluation Group
AVMA
American Veterinary Medical Association
AVRC
AIDS Vaccine Research Committee (also known as Baltimore Committee)
AWA
Animal Welfare Act (1966)
AWAR
Animal Welfare Act Regulations
AWIS
Animal Welfare Information Center
AWRs
Animal Welfare Regulations (USDA)
BAA
Broad Agency Announcement
BACR
British Association for Cancer Research
BAER
Brainstem Auditory Evoked Responce
B ALL
B cell Acute Lymphoblastic Leukaemia
BARQA
British Association of Research Quality Assurance
BARQA
British Association of Research Quality Assurance
BASO
British Association of Surgical Oncologists
BCC
Basal Cell Carcinoma
BCE
Beneficial Clinical Event
BCE
beneficial clinical event
BCHD
Baltimore City Health Department
BDMC
Biostatistics and Data Monitoring Center
BDPA
Bureau of Drug Policy and Administration (China)
BEUC
European Bureau of Consumer Unions
BfArM
Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)
BGA
Bundesgesundheitsamt (Federal health office; former German public health agency)
BGVV
Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany)
BID
Two Times per Day
BID / BD
Twice a day (bis in die)
BIND
Biological Investigational New Drug
BIO
Biotechnology Industry Organization
Biospecimen bank
a facility that collects, catalogs, and stores samples of biological materials (such as urine, blood, tissue, cells, DNA, RNA, and protein) used for laboratory research.
Biostatistics
the use of statistics to analyze biological or health science data.
BIP
Biomedical Imaging Program
BIRA
British Institute of Regulatory Affairs
BLA
Biologics License Application (FDA)
BM
Bone Marrow
BMA
British Medical Association
BMB
Bioresearch Monitoring Branch
BMI
Body Mass Index
BMJ
British Medical Journal
BMR
Basal Metabolic Rate
BMT
Bone Marrow Transplant
BNF
British National Formulary
BNLI
British National Lymphoma Investigation
BOA
British Oncology Association
BODMA
British Oncology Data Managers Association (UK)
BOV
Board of Visitors
BP
Blood pressure
BPI
Bundesverband der Pharmazeutischen Industrie EV (Germany)
BPM
Beats Per Minute
BrAPP
British Association of Pharmaceutical Physicians
BrAPP
British Association of Pharmaceutical Physicians
BRB
Biomedical Research Branch
BREF
Baltimore Research and Education Foundation (at Baltimore VA)
BRIDG
Biomedical Research Integrated Domain Group
BRM
Biological Response Modifier
BSA
Body Surface Area
BSE
Breast Self Examination
BSL
Biosafety Level
BVC
British Veterinary Codex
Bx
Biopsy
C & S
Culture and Sensitivity
C/O
Complaining of
C/W
Continue With
C1 C7
Cervical vertebrae (spine eg. C7 = seventh cervical vertebra)
Ca
Cancer; carcinoma
CA
Chemical Abstracts
CA
Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations)
CAAT
Center for Alternatives to Animal Testing
CAB
Community Advisory Board
CaBig
Cancer Biomedical Informatics Grid
CAC
Carcinogenicity Assessment Committee
CACE
Committee for Advancement of Chemistry Education
caDSR
Cancer Data Standards Repository and toolset maintained by NCI
CALGB
Cancer and Leukemia Group B (USA)
cALL
Common ALL
CANDA
Computer Assisted New Drug Application
CAP
College of American Pathologists
CAPLA
Computer Assisted Product License Application
CAPRA
Canadian Association of Pharmaceutical Regulatory Affairs
CAPRA
Canadian Association of Professional Pharmaceutical Regulatory Affairs (also ACPR Association canadienne des professionnels en réglementation)
CAQ
Certificate of Added Qualifications
CAS
Chemical Abstracts Service
CAS
Chemical Abstracts Service
CASB
Cost Accounting Standards Board
CAT
Computerised axial tomography (scan)
CBC
Complete Blood Count
CBCTN
Community Based Clinical Trials Network
CBER
Center for Biologics Evaluation and Research
CBO
Community Based Organization
cc
Cubic centimeter
CCASE
Coordinating Committee for Advancement of Scientific Education
CCC
Compliance Coordinating Committee (CDER)
CCF
Congestive Cardiac Failure
CCG
Children's Cancer Group (USA)
CCI
Committee on Clinical Investigations. See also Ethics Committee box.
CCM
Center for Comparative Medicine
CCOP
Community Clinical Oncology Program
CCPPRB
Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also Ethics Committee box in the Glossary.
CCR
Continuous complete remission
CCRA
Certified Clinical Research Associate. Certification issued to monitors by ACRP.
CCRC
Certified Clinical Research Coordinator
CCRC
CTSC Clinical Research Center
CCRG
Children's Cancer Research Group (Oxford, UK)
CCRP
Certified Clinical Research Professional (SoCRA)
CCS
Canadian Cancer Society
CCSI
Company Core Safety Information
CCT
Center for Clinical Trials, School of Medicine (UMB)
CDA
Confidential Disclosure Agreement
CDA
Clinical Document Architecture (HL7)
CDASH
Clinical Data Acquisition Standards Harmonization (a 2006 CDISC initiative)
CDC
Centers for Disease Control and Prevention
CDE
common data element
CDER
Center for Drug Evaluation and Research
CDISC
Clinical Data Interchange Standards Consortium(formerly a DIA special interest group called the Clinical Data Interchange Standards Committee)
CDM
clinical data management
CDMS
clinical data management system
CDRH
Center for Devices and Radiological Health
CDUS
Clinical Data Update System
CEA
Carcinoembryonic Antigen (tumour marker)
CEN
Comité Européen de Normalisation(European Committee for Standardization)
CESS
CDER Executive Secretariat Staff
CEU
continuing education unit
CF
Consent Form
CFDA
Catalog of Federal Domestic Assistance
CFH
Connecting for Health
CFR
Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211)
CFSAN
Center of Food Safety and Applied Nutrition
CGH
Comparative Genomic Hybridisation cytogenetics method
CGMP
Current Good Manufacturing Practice
cGy
Centi Gray (unit of radiation)
CH
Clinical Hold
CHAVI
Center for HIV/AIDS Vaccine Immunology
CHF
Congestive heart failure
CHI
Consolidated Health Initiative (eGov)
CHR
Committee on Human Research. See also Ethics Committee box.
CIB
Clinical Investigator's Brochure
CIC
clinical imaging center
CID
CTFA Cosmetic Ingredient Dictionary
CIOMS
Council for International Organizations of Medical Sciences
CIP
Cancer Imaging Program
CIP
Certified IRB Professional
CIR
Cosmetic Ingredient Review
CIRA
Center for Information on Research with Animals
CIS
Commonwealth of Independent States
CITI
Collaborative Institutional Training Initiative
CLIA
Clinical Laboratory Improvement Amendments
CLL
Chronic lymphocytic Leukaemia
cm
centimeter 0.01 meters
Cmax
concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug
CMC
Chemistry and Manufacturing Controls
CMC
Contaminated Materials Container
CMCCC
Chemistry and Manufacturing Controls Coordinating Committee (CDER)
CME
Continuing Medical Education
CMMS
Centers for Medicare and Medicaid Services
CMS
Centers for Medicare & Medicaid Services
CNS
Central nervous system the brain and spine
COE
Code of Ethics
COG
Cooperative Oncology Group (USA)
COI
Conflict of Interest
COLA
Cost of Living Adjustment
COMIS
Center Office Management Information System
CONSORT
Consolidated Standards of Reporting Trials
COP
CDISC Operating Process/Procedure
CORE
CDISC Operational Roadmap Environment (CDISC)
COS
Canadian Oncology Society
COSTART
Coding Symbols for Thesaurus of Adverse Reaction Terms
COSTART
Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA.
CP
Compliance Program
CP
Community Partners
CPCRA
The Terry Beirn Community Programs for Clinical Research on AIDS (DAIDS)
CPHS
Committee for the protection of human subjects
CPMP
Committee for Proprietary Medicinal Products
CPMP
Committee for Proprietary Medicinal Products (EU)
CPR
Cardio pulmonary resuscitation
CPSC
Consumer Product Safety Commission
CR
Complete remission / complete response
CR
Cross Reference (COMIS term)
CRA
Clinical Research Associate
CRADA
Cooperative Research and Development Agreement
CRB
case record book
CRB
central review board
CRC
Cancer Research Campaign (UK)
CRC
Clinical Research Coordinator
CRF
Case Report Form
CRIS
Current Research Information Service
CRISP
Computer Retrieval of Information on Scientific Programs (NIH)
CRIX
Clinical Research Information Exchange
CRO
Contract Research Organisation
CRS
Clinical Research Site
CS
Clinically Significant
CSA or CTA
Clinical Study Agreement or Clinical Trial Agreement
CSDD
Center for the Study of Drug Development
CSF
Cerebro spinal fluid
CSF
Collaborative Standards Forum (CDISC)
CSF
colony stimulating factor
CSI
Consumer Safety Inspector
CSM
Committee on Safety of Medicines (UK)
CSO
Consumer Safety Officer (FDA)
CSR
clinical study report
CSU
clinical supply unit
CSUICI
(replaces CSUCT) Computerized Systems Used In Clinical Investigations. NOTE: usually pronounced "seesweecy."
CT
Computed tomography
CT
clinical trial
CT(X)
Clinical Trial Exemption
CTA
Clinical Trial Agreement
CTC
Computerized tomographic colonography
CTC
Clinical Trial Certificate
CTC
Clinical Trials Coordinator
CTEP
Clinical Therapeutics Evaluation Program (NCI)
CTM
Clinical Trials Manager
CTM
clinical trials materials
CTO
Clinical Trials Office
CTP
Clinical Trials Physician
CTSC
Clinical and Translational Science Center
CTSC
Clinical Research Training Program
CTSU
Clinical Trials Support Unit
CTU
Clinical Trials Unit
CTWG
Community Training Working Group
CTX
Clinical Trials Exemption
CTX
Clinical Trial Exemption Certification
CUI
common unique identifier. A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.
CV
Curriculum Vitae
CVA
Cardiovascular Accident (stroke)
CVC
Central venous catheters
CVM
Center for Veterinary Medicine
CVM
Center for Veterinary Medicine (FDA)
CVP
Central Venous Pressure
CXR
Chest X Ray
D/C
Discharge
D/H
Drug History
D/W
Discussed With
DAIDS
Division of AIDS (NIAID)
DAS
Drug Abuse Staff
DAWN
Drug Abuse Warning Network
DB
Double Blind
DC
Direct Costs
DCE MRI
Dynamic contrast enhanced MRI
DCF
Data Correction Form / Data Clarification Form
DCIS
Ductal Carcinoma In Situ type of breast cancer
DCTD
Division of Cancer Treatment and Diagnosis at the NCI
DD
Department of Drugs(Swedish regulatory agency)
DDF
Data Definition File
DDI
drug–drug interaction
DDIR
Division of Drug Information Resources
DDMAC
Division of Drug Marketing, Advertising, and Communications
DDx
Differential diagnosis
DEA
Drug Enforcement Administration
DEN
Drug Experience Network
DEN
Drug Experience Network
DEQ
Department of Environmental Quality
DES
Division of Epidemiology and Surveillance
DES
Data Encryption Standard
DESI
Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962)
DFI
Disease Free Interval
DFS
Disease Free Survival time without disease prior to relapse or last follow up
DGPharMed
Deutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly ÄPI
DHEW
Department of Health,Education and Welfare (U.S.,now split into DHHS and Department of Education)
DHHS
Department of Health and Human Services
DHR
Maryland Department of Human Resources
DHTML
dynamic HTML (IT)
DI
Diabetes Incipidus
DIA
Drug Information Association
DICOM
Digital imaging and communication in medicine
DIS
Decay in Storage
DISD
Division of Information Systems Design
dl
deciletre 0.01 litres
DLBCL
Diffuse Large B cell Lymphoma
DLCL
Diffuse large cell lymphoma
DLT
Dose limiting toxicity determined by phase 1 studies
DLT
dose limiting toxicity
DM
Data management
DMB
Data Management Biomedical (France)
DMC
Data Monitoring Committee
DMF
Drug Master File
DMIST
Digital Mammographic Imaging Screening Trial
DNR
Do Not Resusitate
DOA
Dead on Arrival
DOD
Department of Defense
DOS
Description of Study
DPC PTR Act
Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman Hatch or Hatch Waxman bill)
DRG
Diagnosis Related Groups
DSI
Division of Scientific Investigations
DSM
Diagnostic and Statistical Manual (of the American Psychiatric Association)
DSMB
Data and Safety Monitoring Board
DSMC
Data and Safety Monitoring Committee
DSNP
development of standardized nomenclature project (FDA)
DSTU
Draft Standard for Trial Use. See HL7 definition .
DSUR
Development Safety Update Report (ICH)
DTC
direct to consumer (drug advertising)
DTD
Document Type Definition (XML)
DUR
Drug Utilization Review
DWI
Diffusion weighted imaging
Dx
Diagnosis
E3C
European CDISC Coordinating Committee
EA
Environmental Assessment
EAB
Ethical Advisory Board
EAB
Editorial Advisory Board (Applied Clinical Trials )
EACR
European Association for Cancer Research
EANO
European Association for NeuroOncology
EBM
Evidence Based Medicine
EBMT
European Group for Blood and Marrow Transplantation
EC
European Commission
EC
Ethics Committee
ECG
Electrocardiogram
ECG
European CDISC Group
ECOG
Eastern Cooperative Oncology Group
ECPHIN
European Community Pharmaceutical Information Network
eCRF
electronic case report form
ECRIN
European Clinical Research Infrastructures Network
eCTD
electronic common technical document
ED
Effective Dose
EDC
Electronic Data Capture
EDC
electronic data capture/collection
EDI
electronic data interchange
eDMS
electronic data management system
EDR
electronic document room. NOTE: The EDR is an extension of the e Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links.
EEG
Electroencephalogram
EER
Establishment Evaluation Request
EFGCP
European Forum for Good Clinical Practice
EFPIA
European Federal of Pharmaceutical Industries Associations
EFS
Event Free Survival time from diagnosis to defined events (eg relapse or deat
eHR
electronic health record
EHS
Environmental Health and Safety
EIA
Establishment Inspection Reports
EICESS
European Intergroup Ewing's Sarcoma Study
EIN
Entity Identification Number
EIR
Establishment Inspection Report
EJC
European Journal of Cancer
ELA
Establishment License Application
ELISA
Enzyme Linked Immunosorbent Assay (test)
ELISpot
Enzyme Linked Immunospot (assay)
EMEA
European Medicines Agency
EMERSE
Electronic Medical Record Search Engine
EMUO
Early Morning Urine Osmolality (evaluating urine concentration)
EMWA
European Medical Writers Association
ENSG
European Neuroblastoma Study Group
ENT
Ear nose throat
EO
Executive Order
EOI
European Osteosarcoma Intergroup
EOP1
End of phase 1
EOP2
End of phase 2
EORTC
European Organisation for Research and Treatment of Cancer
EOS
End of Study
EPA
Environmental Protection Agency
EPAR
European Public Assessment Report
EPL
Effective Patent Life
EPMS
Employee Performance Management System
EPO
European Patent Office; erythropoietin
EPRG
European Pharmacovigilance Research Group
ER
Essential Requirements (EMEA)
ERA
Electronic Research Administration
ERISA
Employee Retirement Insurance Security Act
Erlotinib (Tarceva)
(Tarceva) a drug used to treat locally advanced or metastatic non small cell lung cancer and other cancers. Like gefitinib, it targets epidermal growth factor receptor tyrosine kinase, and specific genetic mutations correlate to patients’ response to the drug.
ERSR
electronic regulatory submissions and review (FDA's e Submissions processing group)
eRX
electronic prescribing
eSDI
electronic Source Data Interchange
ESO
European School of Oncology
ESR
Erythrocyte Sedimentation rate
ESRA
European Society of Regulatory Affairs
ESS
Executive Secretary and Staff
ESTRI
Electronic Standards for the Transfer of Regulatory Information (ICH)
ESTRO
European Society for Therapeutic Radiation and Oncology
ETS
Environmental Tobacco Smoke
ETT
Exercise Tolerance Test
EUDRA
European Union Drug Regulatory Authorities
EudraCT
European Union clinical trials database
EUP
Experimental Use Permit
EUROVAC
European Vaccine Effort Against HIV/AIDS
EVS
Enterprise Vocabulary Services (National Cancer Institute)
EWG
expert working group
F&A Costs
Facilities and Administrative Costs
F/H
Family history
FAB
French American and British classification scheme for leukaemia
FACA
Federal Advisory Committee Act 1972
FAR
Federal Acquisition Regulation
FBC
Full Blood Count
FCCSET
Federal Coordinating Council for Science, Engineering and Technology
FD & C Act
Federal Food, Drug and Cosmetic Act
FDA
Food and Drug Administration (USA)
FDA 1572
FDA Form for Statement of Investigator
FDA 482
Notice of Inspection
FDA 483
Notice of Adverse Findings in an Inspection
FDAAA
Food and Drug Administration Amendment Act (pronounced fedaahh or fedah ah)
FDAMA
FDA Modernization Act
FDA SRS
Spontaneous Reporting System of the Food and Drug Administration
FDCA
Food, Drug, and Cosmetic Act
FDG PET
Fluorodeoxyglucose PET
FDLI
Food and Drug Law Institute
FDP
Federal Demonstration Partnership
FECS
Federation of European Cancer Societies
FEV
Forced expectorant volume (a lung test)
FFA
For Further Appointment
FFDCA
Federal Food, Drug, and Cosmetic Act
FFPM
Fellow of the Faculty of Pharmaceutical Medicine (UK)
FHCRC
Fred Hutchinson Cancer Research Center
FHI
Family Health International
FIC
Fogarty International Center, NIH
FIGO
International Federation of Gynecology and Obstetrics
FIPS
Federal Information Processing Standards
FISH
Flourescence in situ Hybridisation
FMD
Field Management Directives
FMTC
Familial Medullary Thyroid Carcinoma
FNA
Fine Needle Aspiration a type of biposy using a thin needle (or FNAB)
FOI
Freedom of Information
FOIA
Freedom of Information Act
FONSI
Finding of No Significant Impact
FPL
Final Printed Labeling
FPR
Final Proposal Revision
FRC
Federal Records Center (Suitland)
FRCP
Fellow of the Royal College of Physicians, sometimes followed by a place name for example, FRCP (Edin.) that indicates a university medical school
FSIS
Food Safety and Inspection Service
FTE
Full Time Equivalent
FU
Follow up
FUR
Follow up Request
FVC
Forced Vital Capacity
FWA
Federalwide Assurance
g
gram unit of weight
GA
General Anaesthetic
GAO
General Accounting Office
GATT
General Agreement of Tariffs and Trade
GBP
good business practice
Gbps
gigabits, or billions of bits per second (data transmission)
GC
General Counsel (FDA)
GCAB
Global Community Advisory Board
GCP
Good clinical practice
GCRC
General Clinical Research Center
GCRP
good clinical research practice
GDA
Global Disclosure Agreement
GFR
Gromerular filtration rate
GI
Gastrointestinal
GI
Gastrointestinal
GLP
Good Laboratory Practice
GMC
General Medical Council (UK)
GMO
Grants Management Officer
GMP
Good Manufacturing Practice
GOG
Gynecology Oncology Group
GP
general practitioner; general practice (UK)
GPMS
good postmarketing surveillance practice (Japan)
GPOH
Gesellschaft fur Padiatrische Onkologie und Hamatologie (German Paed. Onc Group)
GPR
Good Partial Remission
GPRA
Government Performance and Results Act
GQA
General Qualifying Application
Grade 1 toxicities
mild adverse events.
Grade 3 toxicities
severe adverse events.
Grade 4 toxicities
life threatening or disabling adverse events.
GRAS
Generally Recognized as Safe
GRASE
Generally Recognized as Safe and Effective
GRP
Good Review Practice
GU
Genito urinary
GXP
good (pharmaceutical) practice
Gy
Grays (units of radiation)
H&E
Hematoxylin and Eosin (stain)
H/O
History of
HA
health authority (UK)
HAACP
Hazard Analysis and Critical Control Point (inspection technique)
HAART
Highly Active Antiretroviral Therapy
HAI
Health Action International
HANC
HIV/AIDS Network Coordination
Hb
Haemoglobin
HCFA
Health Care Financing Administration; now renamed The Centers for Medicare & Medicaid Services (CMS).
HCPCS modifier
An HCPCS code descriptor utilized to provide additional information regarding the service or item identified by the HCPCS code, including specific circumstances that may apply to the service or item.
HDC
High Dose Chemotherapy
HEPA
High Efficiency Particulate Air Filter
HEX
Human Experimentation Committee. See also Ethics Committee box in the Glossary.
HF
Routing code for mail to the Office of the Commissioner of the FDA
HFD
Routing code for mail to CDER
HFM
Routing code for mail to CBER
HFS
Routing code for mail to CFSAN
HFT
Routing code for mail to NCTR
HFV
Routing code for mail to CVM
HFZ
Routing code for mail to CDRH
HHS
Health and Human Services (Department of)
HHS
Department of Health and Human Services (U.S., also called DHHS)
HIC
Human Investigation Committee(former name of HSR)
HIE
health information exchange
HIMA
Health Industry Manufacturers Association
HIMSS
Healthcare Information and Management Systems Society (pronounced hymns)
HIPAA
Health Insurance Portability and Accountability Act
HIRE
Human Investigations Involving Radiation Exposure (subcommittee of RSC)
HIT
health information technology
HITSP
Health Information Technology Standards (pronounced hitspee)
HIV
Human Immunodeficiency Virus
HIVNET
HIV Network for Prevention Trials – United States (Closed October 1999)
HL7
Health Level 7 (a not for profit ANSI accredited standards developing/development organization [SDO])
HL A
Human Leukocyte Associated antigens (HL A matching for BMT)
HLA
Human Leucocyte Antigen
HMO
Health Maintenance Organization
HNPCC
Hereditary NonPolyposis Colorectal Cancer
HP
Health Physicist
HPA
Human Protections Administration
HPB
Health Protection Branch, Laboratory Centre for Disease Control (Canada); has been superseded by Health Canada
HPLC
high performance liquid chromatography
HPTN
HIV Prevention Trials Network
HPTU
HIV Prevention Trials Unit
HPV
Human Papilloma Virus implicated in some gynacological cancers
HR
High risk
HRG
Health Research Group
HRRC
Human Research Review Committee
HRSA
Health Resources and Services Administration
HRT
Hormone replacement therapy
HRW
High Risk Women
HSRC
Human Subjects Review Committee. See also Ethics Committee box in the Glossary .
HTLV
Human T cell leukemia lymphoma virus
HTML
Hypertext Markup Language
HTTP
Hypertext Transfer Protocol
HVTN
HIV Vaccine Trials Network
HVTU
HIV Vaccine Trials Unit
HX
History
I3C
India CDISC Coordinating Committee
IAB
Industry Advisory Board (for CDISC)
IACR
International Association of Cancer Registries
IACUC
Institutional Animal Care and Use Committee
IARC
International Agency for Research on Cancer
IASLC
International Association for the Study of Lung Cancer
IAVI
International AIDS Vaccine Initiative
IB
Investigator’s Brochure
IBC
Institutional Biosafety Committee
IC
Informed consent
IC
Chemistry Information Amendment (COMIS term)
IC
informed consent
ICARE
International Cancer Alliance for Research and Education (ICARE)
ICASO
International Council of AIDS Service Organizations
ICCCPO
International Confederation of Childhood Cancer Parent Organisations
ICCG
International Collaborative Cancer Group
ICCPO
Icelandic Childhood Cancer Parent Organisation
ICD
International Classification of Diseases (coding system)
ICD
Informed Consent Document
ICD9
International Classification of Diseases, 9th revision. See also MedDRA.
ICD 9 CM
International Classification of Disease Codes, 9th revision Clinical Modification
ICDO
International Classification of Diseases for Oncology (coding system)
ICF
Intercellular fluid
ICF
informed consent form
ICG
India CDISC Group
ICH
International Conference on Harmonization (GCP)
ICH GCP
ICH Harmonised Tripartite Guideline for Good Clinical Practices
ICLAS
International Council for Laboratory Animal Sciences
ICMJE
International Committee of Medical Journal Editors
ICPEMC
International Commission for Protection Against Mutagens and Carcinogens
ICR
Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK)
ICRF
Imperial Cancer Research Fund (UK)
ICSR
individual case safety report
ICTH
International Committee on Thrombosis and Hemostases
ICTRP
International Clinical Trials Registry Platform (WHO)
ICU
Intensive Care Unit
IDB
Investigational Drug Brochure
IDC
Indirect costs
IDE
Investigational Device Exemption Application to CDRH to get permission for investigational device testing in clinical trials
IDR
Idiosyncratic Drug Reaction
IDS
Investigational Drug Service (pharmacy)
IDSMB
Independent Data Safety Monitoring Board
IDU
Injecting Drug User
IEC
Independent Ethics Committee
IEEE
Institute of Electrical and Electronic Engineers, Inc.
IESS
Intergroup Ewing's Sarcoma Study (USA)
IFAPP
International Federation of Associations of Pharmaceutical Physicians
IFN
Interferon
IFPMA
International Federation of Pharmaceutical Manufacturers and Associations
IG
Inspector General
IG
Immunoglobulin
IHE
Integrating the Healthcare Enterprise (an international standards organization)
IHI
Institute for Healthcare Improvement
IHS
Indian Health Service
IKS
Interkantonale Kontrollstelle für Heilmittel (Switzerland)
IL
Interleukin
IL2
Interleukin2
ILAR
Institute for Laboratory Animal Research
IM
Intramuscular into a muscle
IM
Clinical Information Amendment (COMIS term)
IMI
Innovative Medicines Initiative (European Commission)
IMP
investigational medicinal product; investigational materials plan
IMPAACT
International Maternal Pediatric Adolescent AIDS Clinical Trial Group
IMPD
Investigational Medicinal Product Dossier (EUDRA)
IMRT
Intensity Modulated Radiotherapy
INAD
Investigational New Animal Drug
IND
Investigational new drug
INDA
Investigational New Drug Application
INDC
Investigational New Drug Committee
INFA
International Neurofibromatosis Association
INN
International Nonproprietary Name
INSS
International Neuroblastoma Staging System
Investigational New Drug (IND)
A new molecular, antibiotic, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
IO
Institutional Official
IOM
Institute of Medicine (National Academy of Science, U.S.)
IOM
Institute of Medicine
IPC
Institutional Participants Committee
IPCS
International Program for Chemical Safety
IPRA
International Product Registration Document
IPRO
Independent Pharmaceutical Research Organization
IPRO
independent pharmaceutical research organization. See also CRO.
IPSO
International Society of Pediatric Surgical Oncology
IRB
Institutional Review Board
IRB HSR
Institutional Review Board Health Sciences Research
IRC
Institutes Review Committee
IRD
international registration document
IRG
Integrated Review Group (NIH peer review)
IRG
Initial Review Groups
IRS
Identical, Related, or Similar
IS
International System of Units (may also be referred to as SI Systéme Internationale)
ISCB
International Society for Clinical Biostatistics
ISDN
Integrated Services Digital Network
ISNCC
International Society of Nurses in Cancer Care
ISO
International Organization for Standardization
ISOQOL
International Society for Quality of Life Research
ISP
Internet service provider
ISPE
International Society for Pharmacoepidemiology
IT
Information Technology
ITCC
Information Technology Coordinating Committee (CDER)
ITU
Intensive Therapy Unit
ITU T
International Telecommunication Union Telecommunication Standardization Sector
IU
International units
IUPAC
International Union of Pure and Applied Chemistry
IV
Intravenous into a vein
IVD
In Vitro Diagnostics
IVP
Intravenous Pyelogram type of Xray after injection with iodine dye
J3C
Japan CDISC Coordinating Committee
JCAH
Joint Commission for the Accreditation of Hospitals
JCAHO
Joint Commission on Accreditation of Health Care Organizations
JCG
Japan CDISC Group
JCO
Journal of Clinical Oncology
J Code
An HCPCS code used to bill payors (such as CMS or insurance companies) for drugs. A J code, as opposed to another letter code (i.e., A code or B code), generally signifies an injectable drug that cannot be self administered.
JCPT
Journal of Clinical Pharmacology and Therapeutics
JCRDD
Journal of Clinical Research and Drug Development
JCRP
Journal of Clinical Research and Pharmacoepidemiology
JMA
Japan Medical Association
JPA
Joint Personnel Agreement
JPMA
Japan Pharmaceutical Manufacturers Association
K+
Potassium
Kbps
kilobits, or thousands of bits per second (data transmission)
kg
Kilogram a thousand grams
LAB
Laboratory Data Model (CDISC)
LATA
Laboratory Animal Training Association
LCH
Langerhans cell histiocytocis
LCIS
Lobular Carcinoma In Situ type of breast cancer
LD
Lethal Dose
LD50
Lethal Dose (50%)
LDH
Lactic dehydrogenase high levels correlate with tumour volume in some cancers
LEAA
Law Enforcement Assistance Administration
LERN
Library Electronic Reference Network
LIF
Swedish Pharmaceutical Industry Association
LKP
Leiter der Klinischen Prüfung
LMP
Low Malignant Potential (context: ovarian tumours)
LN
Lymph Node
LNC
Labeling and Nomenclature Committee
LOC
Level of Concern
LOCF
Last Observation Carried Forward
LOINC
logical observations, identifiers, names, and codes
LP
Lumbar puncture
LPP
Local Partnership Project
LRC
Lipid Research Clinic
LREC
Local Research Ethics Committee (UK)
LRF
Leukaemia Research Fund (UK)
LRFA
Lymphoma Research Foundation of America
LRI
Lower Respiratory Infection
LTE
Less Than Effective
LVEF
Left Ventricular Fjection Fraction a heart function test
Lx
Lumpectomy
m
meter (unit of length)
M/H
Medical history
MA
marketing authorization
MAA
Marketing Authorisation Application (EMEA, EU)
MAB mAb
Monoclonal antibody
MACS
Multi center AIDS Cohort Studies
MAH
Marketing Authorisation Holder (EU)
MAPP
Manual of Policy and Procedures
MBC
Minimum Bactericidal Concentration
MBE
Minority Business Enterprise
Mbps
megabits, millions of bits per second (data transmission)
MCA
Medicines Control Agency (UK)
MDI
Metered Dose Inhaler
MDR
Multi drug resistant
MDR
Medical Device Reporting
MDS
Myelo dysplastic syndrome
MedDRA M
Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others)
MedID
Medicinal Product Identifier
MEDLARS
Medical Literature Analysis and Retrieval System
MEDWATCH
MEFA
Association of the Danish Pharmaceutical Industry
MEN
Multiple Endocrine Neoplasia (familial) a.k.a. FMEN
mEq/l
milliequivalent per liter
MERIT
Method to Extend Research in Time award (NIH)
mets
Metastases (where the tumour has spread to secondary sites)
Mg
Magnesium
MHC
Major Histocompatibility Complex
MHLW
Ministry of Health, Labor and Welfare (Japan)
MHRA
Medicines and Healthcare products Regulatory Agency (UK)
MHW
Ministry of Health and Welfare (Japan's equivalent to the FDA)
MI
Miocardial Infarction
MI
Myocardial Infarction
MIAME
minimum information about a microarray experiment (standard for microarray data)
mIBG
Radioactive Iodine Metaidobenzoguanidine (mIBG scans or mIBG therapy).
MIC
Minimum Inhibitory Concentration
ml
millilitre 0.001 liter
MM
Malignant Melanoma
MMR
Minor Modification Review
MO
Medical Officer
MOH
Ministry of Health (UK, Canada, others)
MOP
Manual of Operations
MOPH
Ministry of Public Health (Thailand, Yemen, others)
mOsm
milliosmole
MPCC
Medical Policy Coordinating Committee (CDER)
MPNST
Malignant Peripheral Nerve Sheath Tumour
MPR
Medical Products Agency (Swedish Regulatory Agency)
MQSA
Mammography Quality Standards Act
MR
Medical Representative (Japan)
MRA
Magnetic resonance angiography
MRA
Medical Research Associate
MRC
Medical Research Council (UK)
MREC
Multi centre Research Ethics Committee (UK)
MRgFUS
MR guided focused ultrasound
MRI
Magnetic resonance imaging
MRSI
Magnetic resonance spectroscopic imaging
MRT
Malignant Rhabdoid Tumour
MSM
Men who have Sex with Men
MSSU
Mid stream specimen urine
MTA
Material Transfer Agreement
MTD
Maximum Tolerated Dose
MTDC
Modified Total Direct Costs
MTN
Microbicide Trials Network
MTPCI
Multidisciplinary Training Program in Clinical Investigations
MUD
Matched Urelated Donor for bone marrow transplant
MVP
master validation plan
Mx
Mastectomy
N/V
Nausea and vomiting
NA
Not Approvable
Na+
Sodium
NAACCR
North American Association of Central Cancer Registries
NABCO
National Alliance of Breast Cancer Organizations
NABR
National Association for Biomedical Research
NABTT
New Approaches to Brain Tumor Therapy
NAD
No Abnormality Detected
NADA
New Animal Drug Application
NAF
Notice of Adverse Findings
NAHC
National Advisory Health Council
NAI
No Action Indicated
NAS
National Academy of Sciences
NAS
new active substance (UK)
NAS
National Academy of Sciences –National Research Council (U.S.)
NBAC NRC
National Bioethics Advisory Commission
NBAC
National Bioethics Advisory Commission (U.S.)
NBCCS
Nevoid basal cell carcinoma syndrome
NBM
Nil by mouth
NCA
national competent authority
NCCAM
National Center for Complementary and Alternative Medicine, NIH
NCCF
National Childhood Cancer Foundation (USA)
NCCLS
National Committee for Clinical Laboratory Standards
NCCTG
North Central Cancer Treatment Group
NCE
No Cost Extension
NCE
New Chemical Entity
NCHS
National Center for Health Statistics
NCI
National Cancer Institue (USA)
NCI LSS
National Cancer Institute Lung Screening Study
NCIA
National Cancer Imaging Archive
NCIC
National Cancer Institute of Canada
NCI CIRB
National Cancer Institute Central Institutional Review Board
NCI
National Cancer Institute
NCI PCIRB
Nat. Cancer Inst.. Pediatric Central Inst. Review Board
NCMHD
National Center for Minority Health and Health Disparities, NIH
NCPF
National Cancer Policy Forum
NCRA
National Cancer Registrars Association (USA)
NCRN
National Cancer Research Network
NCRR
National Center for Research Resources, NIH
NCS
Networking and Communications Subcommittee
NCS
Not Clinically Significant
NCTR
National Center for Toxicological Research
NCVIA
National Childhood Vaccine Injury Act (1986)
NDA
New Drug Application
NDE
New Drug Evaluation
NDS
New Drug Study
NECCR
North of England Children's Cancer Research Unit
NED
No evidence of disease
NEFARMA
Dutch Association of the Innovative Pharmaceutical Industry
NEI
National Eye Institute, NIH
NEJM
New England Journal of Medicine
NF
National Formulary
ng
nanogram 0.000000001 gram
NGA
Notice of Grant Award
NGO
Non Governmental Organization
NHGRI
National Human Genome Research Institute, NIH
NHI
National Health Insurance (Japan)
NHIN
National Health Information Network
NHL
Non Hodgkin's Lymphoma
NHLBI
National Heart, Lung, and Blood Institute
NHS
National Health Service (UK)
NHVREI
NIAID HIV Vaccine Research Education Initiative
NHW
National Health and Welfare Department (Canada's equivalent of DHHS)
NIA
National Institute on Aging, NIH
NIAAA
National Institute on Alcohol Abuse and Alcoholism, NIH
NIAID
National Institute of Allergy and Infectious Diseases, NIH
NIAID
National Institute of Allergies and Infectious Diseases (NIH)
NIAMS
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)
NIAMSD
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIBIB
National Institute of Biomedical Imaging and Bioengineering, NIH
NICHD
National Institute of Child Health and Human Development, NIH
NICHD
National Institute of Child Health and Human Development (NIH)
NIDA
National Institute of Drug Abuse, NIH
NIDCD
National Institute on Deafness and Other Communication Disorders, NIH
NIDCD
National Institute of Deafness and other Communication Disorders
NIDCD
National Institute on Deafness and Other Communication Disorders (NIH)
NIDCR
National Institute of Dental and Craniofacial Research, NIH
NIDCR
National Institute of Dental and Craniofacial Research (NIH)
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases, NIH
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases (NIH)
NIDDKD
National Institute of Diabetes And Digestive And Kidney Diseases
NIDR
National Institute of Dental Research
NIEHS
National Institute of Environmental Health Services, NIH
NIGMS
National Institute of General Medical Sciences, NIH
NIH
National Institutes of Health
NIH NRSA
National Research Service Award
NIMH
National Institute of Mental Health, NIH
NINDS
National Institute of Neurological Disorders and Stroke, NIH
NINR
National Institute of Nursing Research (NIH)
NIOSH
National Institute for Occupational Safety and Health, CDC
NIRB
noninstitutional review board, also known as an independent review board. See also Ethics Committee in the Glossary, NIRB.
NK
Natural Killer cells (large lymphocytes, part of the immune system)
NKA
No Known Allergies
NKCA
National Kidney Cancer Association (USA)
NLEA
Nutrition Labeling and Education Act (1990)
NLM
National Library of Medicine, NIH
NLST
National Lung Screening Trial
NME
New Molecular Entity
NMR
Nuclear Magnetic Resonance
NMSC
Non Melanoma Skin Cancer
NNFF
National Neurofibromatosis Foundation (USA)
NOAEL
no observed adverse effect level (IUPAC)
NOEL
No Observed Effect Level
Non Mem
Non linear Nixed Effect Model
NORD
National Organization for Rare Disorders (USA)
NOS
Not otherwise specified (see ICDO)
NPC
Nasopharyngeal Carcinoma
NR
No Reply Necessary (COMIS term)
NRB
noninstitutional review board, also known as an independent review board
NRC
Nuclear Regulatory Commission
NRC
National Research Council
NRCT
National Registry of Childhood Tumours (UK) held by the CCRG at Oxford
NRSA
National Research Service Award (NIH)
NRSTS
Non Rhabdomyosarcoma Soft Tissue Sarcoma
NSABP
National Surgical Adjuvant Breast and Bowel Project
NSAID
Nonsteroidal Anti inflammatory Drug
NSCLC
Non–small cell lung cancer
NSE
Neuron Specific Enolase a neural marker
NSF
National Science Foundation
NSR
Non significant result
NSR
Nonsignificant Risk
NTP
National Toxicology Program
O/E
On Examination
OAI
Official Action Indicated (serious FDA postinspection classification)
OAR
Office of AIDS Research (NIH)
OARAC
Office of AIDS Research Advisory Committee
OASH
Office of the Assistant Secretary for Health
OB GYN
Obstetrics Gynecology
OC
Office of Compliance (CDER)
OCD
Office of the Center Director (CDER)
OCGR
Office of Communications and Government Relations (NIAID)
OCPB
Office of Clinical Pharmacology and Biopharmaceutics (CDER)
OD
Right Eye
ODAC
Oncologic Drugs Advisory Committee (U.S.)
ODB
Observational Database
ODE
Office of Drug Evaluation (CDER)
ODM
Operational Data Model (CDISC)
OEB
Office of Epidemiology and Biostatistics (CDER)
OECI
Organization of European Cancer Institutes
OEHS
Office of Environmental Health and Safety
OGA
Office of Grants and Contracts Administration
OGD
Office of Generic Drugs (CDER)
OHA
Office of Health Affairs
OHITA
Office of Health Information Technology Adoption (ONCHIT)
OHRM
Office of Human Resource Management
OHRP
Office for Human Research Protections
OIG
Office of the Inspector General
OIS
Office of Interoperability and Standards
OJC
Official Journal of the European Union–C Series (Information)
OJEC
Official Journal of the European Communities
OJL
Official Journal of the European Union–L Series (Legislation)
OLAW
Office of Laboratory Animal Welfare (NIH)
OM
Office of Management (CDER)
OMB
Office of Management and Budget
ONB
Olfactory Neuroblastoma
ONCHIT
Office of the National Coordinator for Health Information Technology (HHS)
ONDC
Office of New Drug Chemistry (CDER)
ONR
Office of Naval Research
ONS
Oncology Nursing Society (USA)
OPCRO
Office for Policy in Clinical Research Operations
OPERA
Office of Policy for Extramural Research Administration (NIH)
OPR
Office of Policy and Research
OPRR
Office of Protection for Research Risks
OPS
Office of Pharmaceutical Science (CDER)
ORA
Office of Regulatory Affairs
ORAGS
Office of Research and Graduate Studies, UMB School of Medicine
ORI
Office of Research Integrity
ORM
Office of Review Management (CDER)
ORO
Office of Regional Operations
ORWH
Office of Research on Women’s Health (NIH)
OS
Overall Survival
OS
Left Eye
OSHA
Occupational Safety Health Administration
OSP
U.Va. Office of Sponsored Programs
OTA
Office of Technology Assessment
OTA
Office of Technology Assessment (U.S., abolished 1995)
OTC
Over the Counter Drugs
OTC
Over the counter (non prescription drugs)
OTC
over the counter (refers to nonprescription drugs)
OTCOM
Office of Training and Communications (CDER)
OTR
Office of Testing and Research (CDER)
OU
Both Eyes
OVCR
Office of the Vice Chancellor for Research
PA
Program Announcement (in context of funding searches)
PAB
Pharmaceutical Affairs Branch
PAHO
Pan American Health Organization
PAIR
Patient Advocates in Research
PAITS
Pre Approval Inspection Tracking System
PAR
Postapproval Research
PAVE
Partners for AIDS Vaccine Evaluation
PBSC
Peripheral Blood Stem Cell (see PBSCT)
PBSCH
Peripheral Blood Stem Cell Harvest
PBSCR
Peripheral Blood Stem Cell Rescue (transplant)
PBSCT
Peripheral Blood Stem Cell Transplant
PBTC
Pedi Brain Tumor Consortium
PC
Personal Computer
PCC
Parklawn Computer Center
PCC
Poison Control Center
PCP
Pneumocystis carinii pneumonia
PCR
Polymerase Chain Reaction
PD
Progressive disease
PD
Pharmacodynamics
PDA
Parenteral Drug Association
PDA
personal digital assistant (Palm Pilot, for example)
PDC
Protocol Development Coordinator
PDF
portable document format
PDQ
Physician's Data Query (CancerNet)
PDR
Physician's Desk Reference
PDRC
Protocol Development and Regulatory Compliance
PDUFA
Prescription Drug User Fee Act of 1992
PE
Physical Examination
PEM
prescription event monitoring
PEP
Performance Evaluation Plan
PERI
Pharmaceutical Education & Research Institute (not for profit division of PhRMA)
PET
Positron Emmission Tomography a scan after a small radioactive injection.
PFS
Progression Free Survival
PFT
Pulmonary Function Tests
PFT
pulmonary function test
pg
picogram 0.000000000001 gram
PGT
pharmacogenetics
PGX
pharmacogenomics
pH
hydrogen ion concentration acid / alkaline
Phase I trial
A clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed.
Phase II trial
A clinical trial in which the safety and preliminary efficacy of an intervention are assessed.
Phase III trial
A large scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market.
Phase IV trial
A large scale trial undertaken after FDA approval for safety surveillance to detect rare or long term adverse events. Also known as a post marketing surveillance trial.
PHI
Protected health information
PHI
Protected Health Information
PHI
Protected Health Information
PhPID
pharmaceutical product identifier
PhRMA
Pharmaceutical Research and Manufacturers of America
PhRMA
Pharmaceutical Research and Manufacturers of America
PHRP
Partnership for Human Research Protection, Inc.
PHS
Public Health Service
PHS
Public Health Service
PHS2590
Refers to the form used for noncompeting continuation applications to the NIH
PHS398
Refers to the form used for new and competing renewal applications to the NIH
PI
Principal Investigator
PI
Package Insert (approved product labeling)
PIM
product information management (a system introduced by the EMEA)
PK
Pharmacokinetics
PLA
Patent License Agreement
PLA
Product License Application (when seeking commercialization of a biologic)
PLA/ELA
Product License Application/Establishment License Application
PLWA
Person Living With AIDS
PM
Project Manager
PMA
Pre Market Approval (when seeking commercialization of a device)
PMCC
Project Management Coordinating Committee (CDER)
PMDIT
Project Management
PMS
Postmarketing Surveillance
PN
Protocol Amendment New Protocol (or Pending Review) (COMIS term)
PNET
Primitive neuroectodermal tumour Context: CNS tumours
PNS
Peripheral nervous system nervous system outside the brain and spine.
PO
Purchase Order
PO
Per Os (by mouth)
POG
Pediatric Oncology Group (USA)
PONF
Paediatric Oncology Nurses Forum (UK)
PPA
Poison Prevention Act
PPE
Personal Protective Equipment
PPI
Patient Package Insert
PPO
Policy and Procedure Order
PPO
Preferred Provider Organization
PR
Partial Responce / Partial Remission
PR
Pulse Rate
PRC
Protocol Review Committee U.Va. Cancer Center
PRG
Protocol Representation Group (CDISC)
PRIM & R
Public Responsibility in Medicine and Research
prn
as required
PRN
As Needed
PRO
patient reported outcome
Process map
A visual representation of a workflow comprising a stream of activities that transforms a well defined input or set of inputs into a pre defined set of outputs.
PROG
Peer Review Oversight Group (NIH)
PROMIS
Patient Reported Outcomes Measurement Information Systems (pronounced promise)
Protocol
A study plan on which a clinical trial is based. The plan is designed to safeguard the health of participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
PRT
Primary Review Team
PSA
Protocol specific Application
PSRC
Prevention Sciences Review Committee
PSUR
periodic safety update report
PTAO/PTAEO
Project Task Award Office
PTC
points to consider
PTCC
Pharmacology/Toxicology Coordinating Committee (CDER)
PTN
(see HPTN)
PTV
Primary tumor volume
PV
pharmacovigilance
PWA
Person With AIDS
QA
Quality Assurance
QALY
Quality Adjusted Life Year
QARC
Quality Assurance Review Center
QAU
Quality Assurance Unit
QC
Quality Control
QD
Once Daily
qid
Four times a day (quater in die)
QL
Quality of Life
QNS
Quantity Not Sufficient
QOD
Every Other Day
QoL
Quality of Life
QOL
quality of life (also QoL)
R & D
Research and Development
RA
Research Associate
RAB
Regulatory Affairs Branch (DAIDS)
RAC
Reviewer Affairs Committee (CDER)
RADAR
Risk Assessment of Drugs Analysis and Response
RAPS
Regulatory Affairs Professionals Society
RBC
Red blood cell / red blood count
RC
Research Coordinator
RCC
Research Coordinating Committee (CDER)
RCC
Regulatory Compliance Center (DAIDS)
RCH
Remove Clinical Hold
RCR
Responsible Conduct of Research
RCRA
Regional Clinical Research Associate
RCRIM
Regulated Clinical Research Information Management, a technical committee of HL7 with responsibility for developing technical standards for the exchange and management of health research information to be submitted to regulatory authority(ies)
RCT
Randomized Clinical Trial
RD
Response to Request for Information (COMIS term)
RDE
Remote Data Entry
RDRC
Radioactive Drug Research Committee
RDT
Rising dose tolerance
REB
research ethics board (Canada)
REMS
Risk Evaluation and Mitigation Strategy (FDA, in FDAAA)
RFA
Radiofrequency ablation
RFD
retrieve form for data capture
RFP
Request for Proposals (Contracts)
RFQ
Request for Quote
RHIO
regional health information organization
RIF
Reduction In Force
RIGS
Radioimmunoguided surgery
RIM
Reference Information Model (HL7)
RKI
Robert Koch Institut, Bundesinstitut für Infektionskrankheiten und nich übertragbare Krankheiten (Federal Institute for Infectious and Noncommunicable Diseases, Germany)
RL
Regulatory Letter
RMO
Regulatory Management Officer
RMS
Rhabdomyosarcoma
RMW
Regulated Medical Waste
ROC
Receiver operating characteristic
ROE
Report of Expenditures
RPE
Radiation Producing Equipment
RPS
Regulated Product Submission (HL7 RCRIM)
RSC
Radiation Safety Committee
RSO
Radiation Safety Officer
RT
Radiotherapy
RTF
Refuse To File
RTOG
Radiation Therapy Oncology Group
RTPCR
Reverse transcriptase polymerase chain reaction
RUG
Resource Utilization Group
Rx
Treatment
S
Standard
SA
Surface area (see BSA)
SAAVI
South African AIDS Vaccine Initiative
SACHRP
Secretary's Advisory Committee on Human Protection. See also OHRP .
SADR
suspected adverse drug reaction (FDA)
SAE
Serious adverse event
SAG
Science Administration Group
SAL
Sterility Assurance Level
SAS
Statistical Analysis System (commonly used statistical analysis package)
SATCM
State Administration of Traditional Chinese Medicine (China)
SBA
Summary Basis of Approval
SBIR
Small Business Innovation Research Grant
SBS IRB
Social and Behavioral Sciences Institutional Review Board
SC
Subcutaneous
SC
Study Coordinator
SCAW
Scientists Center for Animal Welfare
SCDM
Society for Clinical Data Management
SCHARP
Statistical Center for HIV AIDS Research and Prevention
SCLC
Small cell lung cancer
SCSO
Supervisory Consumer Safety Officer
SCT
Society for Clinical Trials
SCTN
Scottish Cancer Therapy Network
SD
Stable Disease
SD
Standard Deviation
SD
Source Document
SDA
State Drug Administration (China)
SDM
Submission Data Model (CDISC)
SDMC
Statistical and Data Management Center
SDO
standards development organization
SDS
Submission Data Standards (CDISC)
SDTM
Study Data Tabulation Model (CDISC)
SDV
Source Data Verification
SDV
source document (data) verification
SE
Standard Error
SE
standard error (statistics)
SEA
Single European Act of 1987
SEER
Surveillance, Epidemiology, and End Results (Registry of NCI)
SEG
Special Emphasis Group (Laboratory)
SEND
Standard for the Exchange of Nonclinical Data. NOTE: The focus of the SEND Team is on data collected from animal toxicology studies. [CDISC]
SES
Senior Executive Service
SF
Standard Form (Federal)
SFOP
French Paediatric Oncology Scociety
SGDM
Study Group on Data Management (EORTC)
SGML
Standard Generalized Markup Language
SGO
Society of Gynecologic Oncologists
SGOT
Serum glutamic oxalacetic transaminase a liver function test
SGPT
Serum glutamic pyruvic transaminase a liver function test
SHIV
Simian Human Immunodeficiency Virus
SHO
Senior House Officer
SIAC
Special Interest Area Community (DIA)
SIG
Special Interest Group (HL7)
SIOP
International Society of Paediatric Oncology
SIV
Simian Immunodeficiency Virus
SLA
service level agreement
SMART
Submission Management and Review Tracking
SMDA
Safe Medical Devices Act (1990)
SME
Significant Medical Event
SMO
Site Management Organization
SmPC
summary of product characteristics. See also SPC.
SNAP
Streamlined Noncompeting Award Process (NIH)
SNDA
Supplemental New Drug Application
SNIP
Syndicat National de l'Industrie Pharmaceutique (France)
SNLG
Scottish and Newcastle Lymphoma Group
SNOMED
Systematized Nomenclature of Medicine (a dictionary)
SNP
Single Nucleotide Polymorphism
SOAP
simple object access protocol (a W3C XML initiative)
SOB
Short of breath
SoCRA
Society of Clinical Research Associates
SOM
School of Medicine
SOMCTO
School of Medicine Clinical Trials Office
SOMOGC
School of Medicine Office of Grants and Contracts Administration
SON
School of Nursing
SOP
Standard operating procedure
SOW
Scope of Work
SPAC
State Pharmaceutical Administration of China
SPC
summary of product characteristics. See also SmPC.
SPL
Structured Product Labeling (HL7, FDA)
SPM
Society of Pharmaceutical Medicine (UK)
SPOHNC
Support for People with Oral and Head and Neck Cancer
SPORE
Specialized Programs of Research Excellence
SQ
Subcutaneous
SQA
Society of Quality Assurance
SQAP
systems quality assurance plan
SRA
Society of Research Administrators
SRA
Staff Research Associate
SRS
Spontaneous Reporting System
SSC
Scientific Steering Committee (HVTN)
SSC
study site coordinator. See also CRC, CCRC, SC.
SSCT
Swedish Society for Clinical Trials
SSFA
Società di Scienze Farmacologiche Applicate (Italy)
SSM
Superficial Spreading Melanoma
SSM
Skin Surface Microscopy
STD
Sexually Transmitted Disease
STF
study tagging file
STI
Sexually Transmitted Infection
STT
Short Term Tests
STTR
Small Business Technology Transfer Grant
SUAE
serious unexpected adverse event
SUD
sudden unexpected death
SUPAC
Scale up and post approval changes
SWG
Strategic Working Group
SWOG
Southwest Oncology Group
SX
Symptoms
TAC
Technical Advisory Committee (CDISC)
TAMs
tumour associated macrophages
TBI
Total body irradiation
TC
Technical Committee (HL7)
TCC
Transitional Cell Carcinoma (usually bladder cancer)
TCP
Thrombocytopenia
TCP/IP
Transmission Control Protocol/Internet Protocol
TDC
Total Direct Costs
tds / tid
Three times a day (ter in die)
TESS
treatment emergent signs and symptoms
TID
Three Times A Day
TIND
Treatment IND
TK
Toxicokinetics
Tmax
the time after dosing when Cmax occurs
TMO
trial management organization
TNF
Tumour Necrosis Factor
TNM
Staging system primary tumour
TOP
Topical
TPN
total parenteral nutrition
TRK
Transketolase
TSH
Thyroid Stimulating Hormone
UA
Urinalysis
ug
microgram 0.000001 gram
UICC
Union Internationale Contre le Cancer International Union Against Cancer
UKACR
UK Association of Cancer Registeries
UKCCCR
UK Coordinating Committee for Cancer Research
UKCCR
United Kingdom Coordinating Committee on Cancer Research
UKCCRG
UK Children's Cancer Research Group (Oxford)
UKCCSG
UK Children's Cancer Study Group (UK)
ULN
Upper Limits of Normal
UMMS
University of Maryland Medical System
UMT
universal mean time (also known as Greenwich mean time). See UTC.
UNAIDS
Joint United Nations Programme on HIV/AIDS
UNESCO
United Nations Educational Science and Cultural Organization
UNK
Unknown
URL
uniform resource locator (address of a Web site)
URTI
Upper respiratory tract infection
US
Ultrasound (scan)
USAN
United States Adopted Name
USDA
United States Department of Agriculture
USMHRP
U.S. Military HIV Research Project
USP
U.S. Pharmacopeia
USPC
U.S. Pharmacopeial Convention
USP DI
United States Pharmacopeia Drug Information
USPIO
Ultrasmall particle superparamagnetic iron oxide
USP NF
United States Pharmacopeia National Formulary
UST
user site testing. Synonym for UAT (user acceptance testing)
USUHS
Uniformed Services University of the Health Sciences
UTI
Urinary Tract Infection
UVR
Ultra Violet Radiation
VA
Department of Veteran’s Affairs (Federal)
VAERS
Vaccine Adverse Event Reporting System
VAI
Voluntary Action Indicated
VAI
Voluntary Action Indicated (FDA postaudit inspection classification)
VAI
Voluntary Action Indicated (post FDA audit inspection classification)
Value stream mapping
a lean process visualization technique used to analyze the flow of materials and information through a system. The goal of value stream mapping is to understand and streamline the work processes by reducing waste, or activities that do not add value.
VCDE
vocabularies and common data elements (caBIG)
VDGIF
Virginia Dept. of Game and Inland Fisheries
VEF
Ventricular ejection fraction (tests lung function)
VGDS
voluntary genomic data submission
VIEW
Virtual Imaging Evaluation Workspace
VM 26
Teniposide (anti cancer drug)
VMA
Vanillylmandelic Acid
VP 16
Etoposide (anti cancer drug)
VPRP
Vaccine and Prevention Research Program (DAIDS)
VRC
Dale and Betty Bumpers Vaccine Research Center (NIAID/NIH)
VS
Vital Signs
VTN
(see HVTN)
WBC
White blood cell count
WCC
White cell count
WD
Withdrawn (COMIS term)
WHO
World Health Organization
WHOART
World Health Organization Adverse Reaction Terminology
WI
Inactive (COMIS term)
WIHS
Women's Interagency HIV Study (DAIDS)
WITS
Women and Infants Transmission Study (DAIDS)
WL
Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days)
WNL
Within Normal Limits
WOCBP
Women of Child Bearing Potential
WR
written request
WRAIR
Walter Reed Army Institute of Research
WTO
World Trade Organization
WVA
World Veterinary Association
WWW
World Wide Web
XIP
EXtensible Imaging Platform
XML
eXtensible Markup Language
XRT
Radiotherapy (external)
YST
Yolk sac tumour (aka. germ cell tumour)

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