Acronyms of Clinical Trial Terms

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For acronyms of clinical trial names, click here

Acronym Definition
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
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/data/articlestandard/appliedclinicaltrials/502008/571306/i2_t.jpg
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
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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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