Acronyms of Clinical Trial Terms: Difference between revisions
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''For acronyms of clinical trial names, click [[Clinical trial names|here]]'' | ''For acronyms of clinical trial names, click [[Clinical trial names|here]]'' | ||
; AA: Anaplastic Anaemia | ; AA: Anaplastic Anaemia | ||
; AAALAC: Association for Assessment and Accreditation of Laboratory Animal Care | ; AAALAC: Association for Assessment and Accreditation of Laboratory Animal Care | ||
Revision as of 15:34, 3 July 2009
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Please Join in Editing This Page and Apply to be an Editor-In-Chief for this topic: There can be one or more than one Editor-In-Chief. You may also apply to be an Associate Editor-In-Chief of one of the subtopics below. Please mail us [2] to indicate your interest in serving either as an Editor-In-Chief of the entire topic or as an Associate Editor-In-Chief for a subtopic. Please be sure to attach your CV and or biographical sketch.
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
- 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)