Acronyms of Clinical Trial Terms

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List of terms related to Acronyms of Clinical Trial Terms

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

For acronyms of clinical trial names, click here

AA

Anaplastic Anaemia

AAALAC

Association for Assessment and Accreditation of Laboratory Animal Care

AAALAC

Assoc. for Assessment and Accreditation of Laboratory Animal Care International

AAAS

American Association for the Advancement of Science

AABB

American Association of Blood Banks

AACR

American Association for Cancer Research

AACR

American Association for Cancer Research

AADA

Abbreviated Antibiotic Drug Application

AAFP

American Academy of Family Physicians

AAHRPP

.

AAI

American Academy of Immunologists

AALAS

American Assoc. for Laboratory Animal Science

AAMC

Association of American Medical Colleges

AAP

American Association of Pathologists

AAPS

American Association of Pharmaceutical Scientists

ABC

Advanced Breast Cancer

ABMT

Autologous bone marrow transplant

ABPI

Association of the British Pharmaceutical Industry

ABSL

Animal Biosafety Level

ABTA

American Brain Tumour Association

ACCP

American College of Clinical Pharmacology

Accrual

the enrollment of qualified patients into clinical trials.

Accrue

to enroll qualified patients into clinical trials.

ACDM

Association for Clinical Data Management

ACE

Adverse Clinical Event

ACIL

American Council of Independent Laboratories

ACIL

A national trade association representing independent, commercial scientific, and engineering firms

ACLAM

American College of Laboratory Animal Medicine

ACNP

American College of Nuclear Physicians

ACOR

Association of Cancer Online Resources

ACOSOG

American College of Surgeons Oncology Group

ACP

Associates of Clinical Pharmacology

ACPU

Association of Clinical Pharmacology Units

ACR

American College of Radiology

ACRA

Associate Commissioner of Regulatory Affairs

ACRP

Association of Clinical Research Professionals

ACRPI

Association of Clinical Research for the Pharmaceutical Industry

ACRPI

Changed its name to Institute of Clinical Research (UK)

ACS

American Cancer Society

ACS

American Chemical Society

ACT

Applied Clinical Trials

ACTG

AIDS Clinical Trials Group (DAIDS)

ACTG

AIDS Clinical Trials Group (NIAID)

ACTU

AIDS Clinical Trials Unit (NIH)

ACT UP

AIDS Coalition to Unleash Power

ACUC

Animal Care and Use Committee

ADaM

Analysis Data Model (a CDISC standard)

ADaM

Analysis Dataset Model (CDISC)

ADAMHA

Alcohol, Drug Abuse and Mental Health Administration

ADE

Adverse Drug Event

ADI

Acceptable Daily Intake

Adjuvant therapy

medical treatment given in addition to a primary treatment. In the case of cancer, this can be chemotherapy, radiation, or hormone therapy given in addition to surgical removal of a tumor, for example. Adjuvant therapies are used to enhance the effect of primary treatment, and would not necessarily be expected to have therapeutic effect in the absence of the primary treatment.

ADME

Absorption, Distribution, Metabolism and Excretion

ADP

Automated Data Processing

ADR

Adverse Drug Reaction

ADRS

Adverse Drug Reporting System

AE

Adverse Event (any negative or unwanted effect from a drug, device, or medical test).

AEGIS

ADROIT Electronically Generated Information Service, a subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency’s ADROIT (Adverse Drug Reaction On line Information Tracking) database.

AERS

Adverse Event Reporting System (FDA)

AFCR

American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)

AFDO

Association of Food and Drug Officials

AFMR

American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)

AFP

Alphafetoprotein eg. expressed by germ cell tumours and other cancers

AHA

American Heart Association

AHCPR

Agency for Health Care Policy and Research

AHCPR

Agency for Health Care Policy Research (NIH)

AHRQ

Agency for Healthcare Research and Quality

AICRC

Association of Independent Clinical Research Contractors (UK)

AIDS

Acquired immune deficiency syndrome

AIG

Active Ingredient Group

AIM

Active Ingredient Manufacturer

AIOM

Italian Association for Medical Oncology

AIP

Abbreviated Inspection Program

AIRO

Associazione Italiana di Radioterapia Oncologica

AIUM

American Institute of Ultrasound in Medicine

AJCC

American Joint Committee on Cancer

ALARA

As Low As Reasonably Achieved

ALAT

Alanine aminotransferase / alinine transaminase

ALCL

Anaplastic Large cell Lymphoma

ALCOA

attributable, legible, contemporaneous, original, accurate (dimensions of data quality)

ALL

Acute lymphoblastic leukaemia

ALT

Alanine Aminotransferase

am

ante meridian, morning (12:00 midnight thru 11:59:59)

AMA

American Medical Association

AMA DE

AMA Drug Evaluations

AMC

Antibody mediated cytotoxicity

AMF

Administrative Management of the Files

AmFAR

American Foundation for AIDS Research

AMG

West Germany Drug Law

AMKL

acute megakaryocytic leukemia

AML

Acute Myeloid leukemia

AMWA

American Medical Writers Association

ANADA

Abbreviated New Animal Drug Application

ANC

Absolute neutrophil count

ANDA

Abbreviated New Drug Application (for a generic drug)

ANED

Alive no evidence of disease

ANLL

Acute non lymphatic leukaemia

ANOVA

Analysis of variance

ANSI

American National Standards Institute

AO

Administrative Official

AOAC

Association of Official Analytical Chemists

AOAC

Association of Official Analytical Chemists

APB

Association Pharmaceutique Belge (Belgium)

APhA

American Pharmaceutical Association

APHIS

Animal and Plant Health Inspection Service

APHIS

Animal and Plant Health Inspection Service (USDA)

API

active pharmaceutical ingredient

APPI

Academy of Pharmaceutical Physicians and Investigators

AQL

Acceptable Quality Level

ARCS

Association of Regulatory & Clinical Scientists (Australia)

ARENA

Applied Research Ethics National Association

ARMS

Alveolar rhabdomyosarcoma

ARO

academic research organization

ART

Antiretroviral Therapy

ASA

American Statistical Association

ASAP

administrative systems automation project (FDA)

ASCII

American Standard Code for Information Interchange (computer files)

ASCO

American Society of Clinical Oncology

ASCPT

American Society for Clinical Pharmacology and Therapeutics

ASCPT

American Society for Clinical Pharmacology and Therapeutics

ASH

American Society for Hematology

ASM

American Society for Microbiology

ASO

AIDS Service Organization

ASQ

American Society for Quality, formerly American Society for Quality Control

ASR

Age Standardised Rate (Incidence)

ASTRO

American Society for Therapeutic Radiology and Oncology

AT

Active (COMIS term)

ATC

Anatomic Therapeutic Chemical Coding dictionary

ATF

Bureau of Alcohol, Tobacco, and Firearms

AU

Authorized User

AUC

Area Under the Curve (an expression of exposure)

AV

Attending Veterinarian

AVAC

AIDS Vaccine Advocacy Coalition

AVEG

AIDS Vaccine Evaluation Group

AVMA

American Veterinary Medical Association

AVRC

AIDS Vaccine Research Committee (also known as Baltimore Committee)

AWA

Animal Welfare Act (1966)

AWAR

Animal Welfare Act Regulations

AWIS

Animal Welfare Information Center

AWRs

Animal Welfare Regulations (USDA)

BAA

Broad Agency Announcement

BACR

British Association for Cancer Research

BAER

Brainstem Auditory Evoked Responce

B ALL

B cell Acute Lymphoblastic Leukaemia

BARQA

British Association of Research Quality Assurance

BARQA

British Association of Research Quality Assurance

BASO

British Association of Surgical Oncologists

BCC

Basal Cell Carcinoma

BCE

Beneficial Clinical Event

BCE

beneficial clinical event

BCHD

Baltimore City Health Department

BDMC

Biostatistics and Data Monitoring Center

BDPA

Bureau of Drug Policy and Administration (China)

BEUC

European Bureau of Consumer Unions

BfArM

Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)

BGA

Bundesgesundheitsamt (Federal health office; former German public health agency)

BGVV

Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany)

BID

Two Times per Day

BID / BD

Twice a day (bis in die)

BIND

Biological Investigational New Drug

BIO

Biotechnology Industry Organization

Biospecimen bank

a facility that collects, catalogs, and stores samples of biological materials (such as urine, blood, tissue, cells, DNA, RNA, and protein) used for laboratory research.

Biostatistics

the use of statistics to analyze biological or health science data.

BIP

Biomedical Imaging Program

BIRA

British Institute of Regulatory Affairs

BLA

Biologics License Application (FDA)

BM

Bone Marrow

BMA

British Medical Association

BMB

Bioresearch Monitoring Branch

BMI

Body Mass Index

BMJ

British Medical Journal

BMR

Basal Metabolic Rate

BMT

Bone Marrow Transplant

BNF

British National Formulary

BNLI

British National Lymphoma Investigation

BOA

British Oncology Association

BODMA

British Oncology Data Managers Association (UK)

BOV

Board of Visitors

BP

Blood pressure

BPI

Bundesverband der Pharmazeutischen Industrie EV (Germany)

BPM

Beats Per Minute

BrAPP

British Association of Pharmaceutical Physicians

BrAPP

British Association of Pharmaceutical Physicians

BRB

Biomedical Research Branch

BREF

Baltimore Research and Education Foundation (at Baltimore VA)

BRIDG

Biomedical Research Integrated Domain Group

BRM

Biological Response Modifier

BSA

Body Surface Area

BSE

Breast Self Examination

BSL

Biosafety Level

BVC

British Veterinary Codex

Bx

Biopsy

C & S

Culture and Sensitivity

C/O

Complaining of

C/W

Continue With

C1 C7

Cervical vertebrae (spine eg. C7 = seventh cervical vertebra)

Ca

Cancer; carcinoma

CA

Chemical Abstracts

CA

Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations)

CAAT

Center for Alternatives to Animal Testing

CAB

Community Advisory Board

CaBig

Cancer Biomedical Informatics Grid

CAC

Carcinogenicity Assessment Committee

CACE

Committee for Advancement of Chemistry Education

caDSR

Cancer Data Standards Repository and toolset maintained by NCI

CALGB

Cancer and Leukemia Group B (USA)

cALL

Common ALL

CANDA

Computer Assisted New Drug Application

CAP

College of American Pathologists

CAPLA

Computer Assisted Product License Application

CAPRA

Canadian Association of Pharmaceutical Regulatory Affairs

CAPRA

Canadian Association of Professional Pharmaceutical Regulatory Affairs (also ACPR Association canadienne des professionnels en réglementation)

CAQ

Certificate of Added Qualifications

CAS

Chemical Abstracts Service

CAS

Chemical Abstracts Service

CASB

Cost Accounting Standards Board

CAT

Computerised axial tomography (scan)

CBC

Complete Blood Count

CBCTN

Community Based Clinical Trials Network

CBER

Center for Biologics Evaluation and Research

CBO

Community Based Organization

cc

Cubic centimeter

CCASE

Coordinating Committee for Advancement of Scientific Education

CCC

Compliance Coordinating Committee (CDER)

CCF

Congestive Cardiac Failure

CCG

Children's Cancer Group (USA)

CCI

Committee on Clinical Investigations. See also Ethics Committee box.

CCM

Center for Comparative Medicine

CCOP

Community Clinical Oncology Program

CCPPRB

Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also Ethics Committee box in the Glossary.

CCR

Continuous complete remission

CCRA

Certified Clinical Research Associate. Certification issued to monitors by ACRP.

CCRC

Certified Clinical Research Coordinator

CCRC

CTSC Clinical Research Center

CCRG

Children's Cancer Research Group (Oxford, UK)

CCRP

Certified Clinical Research Professional (SoCRA)

CCS

Canadian Cancer Society

CCSI

Company Core Safety Information

CCT

Center for Clinical Trials, School of Medicine (UMB)

CDA

Confidential Disclosure Agreement

CDA

Clinical Document Architecture (HL7)

CDASH

Clinical Data Acquisition Standards Harmonization (a 2006 CDISC initiative)

CDC

Centers for Disease Control and Prevention

CDE

common data element

CDER

Center for Drug Evaluation and Research

CDISC

Clinical Data Interchange Standards Consortium(formerly a DIA special interest group called the Clinical Data Interchange Standards Committee)

CDM

clinical data management

CDMS

clinical data management system

CDRH

Center for Devices and Radiological Health

CDUS

Clinical Data Update System

CEA

Carcinoembryonic Antigen (tumour marker)

CEN

Comité Européen de Normalisation(European Committee for Standardization)

CESS

CDER Executive Secretariat Staff

CEU

continuing education unit

CF

Consent Form

CFDA

Catalog of Federal Domestic Assistance

CFH

Connecting for Health

CFR

Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211)

CFSAN

Center of Food Safety and Applied Nutrition

CGH

Comparative Genomic Hybridisation cytogenetics method

CGMP

Current Good Manufacturing Practice

cGy

Centi Gray (unit of radiation)

CH

Clinical Hold

CHAVI

Center for HIV/AIDS Vaccine Immunology

CHF

Congestive heart failure

CHI

Consolidated Health Initiative (eGov)

CHR

Committee on Human Research. See also Ethics Committee box.

CIB

Clinical Investigator's Brochure

CIC

clinical imaging center

CID

CTFA Cosmetic Ingredient Dictionary

CIOMS

Council for International Organizations of Medical Sciences

CIP

Cancer Imaging Program

CIP

Certified IRB Professional

CIR

Cosmetic Ingredient Review

CIRA

Center for Information on Research with Animals

CIS

Commonwealth of Independent States

CITI

Collaborative Institutional Training Initiative

CLIA

Clinical Laboratory Improvement Amendments

CLL

Chronic lymphocytic Leukaemia

cm

centimeter 0.01 meters

Cmax

concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug

CMC

Chemistry and Manufacturing Controls

CMC

Contaminated Materials Container

CMCCC

Chemistry and Manufacturing Controls Coordinating Committee (CDER)

CME

Continuing Medical Education

CMMS

Centers for Medicare and Medicaid Services

CMS

Centers for Medicare & Medicaid Services

CNS

Central nervous system the brain and spine

COE

Code of Ethics

COG

Cooperative Oncology Group (USA)

COI

Conflict of Interest

COLA

Cost of Living Adjustment

COMIS

Center Office Management Information System

CONSORT

Consolidated Standards of Reporting Trials

COP

CDISC Operating Process/Procedure

CORE

CDISC Operational Roadmap Environment (CDISC)

COS

Canadian Oncology Society

COSTART

Coding Symbols for Thesaurus of Adverse Reaction Terms

COSTART

Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA.

CP

Compliance Program

CP

Community Partners

CPCRA

The Terry Beirn Community Programs for Clinical Research on AIDS (DAIDS)

CPHS

Committee for the protection of human subjects

CPMP

Committee for Proprietary Medicinal Products

CPMP

Committee for Proprietary Medicinal Products (EU)

CPR

Cardio pulmonary resuscitation

CPSC

Consumer Product Safety Commission

CR

Complete remission / complete response

CR

Cross Reference (COMIS term)

CRA

Clinical Research Associate

CRADA

Cooperative Research and Development Agreement

CRB

case record book

CRB

central review board

CRC

Cancer Research Campaign (UK)

CRC

Clinical Research Coordinator

CRF

Case Report Form

CRIS

Current Research Information Service

CRISP

Computer Retrieval of Information on Scientific Programs (NIH)

CRIX

Clinical Research Information Exchange

CRO

Contract Research Organisation

CRS

Clinical Research Site

CS

Clinically Significant

CSA or CTA

Clinical Study Agreement or Clinical Trial Agreement

CSDD

Center for the Study of Drug Development

CSF

Cerebro spinal fluid

CSF

Collaborative Standards Forum (CDISC)

CSF

colony stimulating factor

CSI

Consumer Safety Inspector

CSM

Committee on Safety of Medicines (UK)

CSO

Consumer Safety Officer (FDA)

CSR

clinical study report

CSU

clinical supply unit

CSUICI

(replaces CSUCT) Computerized Systems Used In Clinical Investigations. NOTE: usually pronounced "seesweecy."

CT

Computed tomography

CT

clinical trial

CT(X)

Clinical Trial Exemption

CTA

Clinical Trial Agreement

CTC

Computerized tomographic colonography

CTC

Clinical Trial Certificate

CTC

Clinical Trials Coordinator

CTEP

Clinical Therapeutics Evaluation Program (NCI)

CTM

Clinical Trials Manager

CTM

clinical trials materials

CTO

Clinical Trials Office

CTP

Clinical Trials Physician

CTSC

Clinical and Translational Science Center

CTSC

Clinical Research Training Program

CTSU

Clinical Trials Support Unit

CTU

Clinical Trials Unit

CTWG

Community Training Working Group

CTX

Clinical Trials Exemption

CTX

Clinical Trial Exemption Certification

CUI

common unique identifier. A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.

CV

Curriculum Vitae

CVA

Cardiovascular Accident (stroke)

CVC

Central venous catheters

CVM

Center for Veterinary Medicine

CVM

Center for Veterinary Medicine (FDA)

CVP

Central Venous Pressure

CXR

Chest X Ray

D/C

Discharge

D/H

Drug History

D/W

Discussed With

DAIDS

Division of AIDS (NIAID)

DAS

Drug Abuse Staff

DAWN

Drug Abuse Warning Network

DB

Double Blind

DC

Direct Costs

DCE MRI

Dynamic contrast enhanced MRI

DCF

Data Correction Form / Data Clarification Form

DCIS

Ductal Carcinoma In Situ type of breast cancer

DCTD

Division of Cancer Treatment and Diagnosis at the NCI

DD

Department of Drugs(Swedish regulatory agency)

DDF

Data Definition File

DDI

drug–drug interaction

DDIR

Division of Drug Information Resources

DDMAC

Division of Drug Marketing, Advertising, and Communications

DDx

Differential diagnosis

DEA

Drug Enforcement Administration

DEN

Drug Experience Network

DEN

Drug Experience Network

DEQ

Department of Environmental Quality

DES

Division of Epidemiology and Surveillance

DES

Data Encryption Standard

DESI

Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962)

DFI

Disease Free Interval

DFS

Disease Free Survival time without disease prior to relapse or last follow up

DGPharMed

Deutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly ÄPI

DHEW

Department of Health,Education and Welfare (U.S.,now split into DHHS and Department of Education)

DHHS

Department of Health and Human Services

DHR

Maryland Department of Human Resources

DHTML

dynamic HTML (IT)

DI

Diabetes Incipidus

DIA

Drug Information Association

DICOM

Digital imaging and communication in medicine

DIS

Decay in Storage

DISD

Division of Information Systems Design

dl

deciletre 0.01 litres

DLBCL

Diffuse Large B cell Lymphoma

DLCL

Diffuse large cell lymphoma

DLT

Dose limiting toxicity determined by phase 1 studies

DLT

dose limiting toxicity

DM

Data management

DMB

Data Management Biomedical (France)

DMC

Data Monitoring Committee

DMF

Drug Master File

DMIST

Digital Mammographic Imaging Screening Trial

DNR

Do Not Resusitate

DOA

Dead on Arrival

DOD

Department of Defense

DOS

Description of Study

DPC PTR Act

Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman Hatch or Hatch Waxman bill)

DRG

Diagnosis Related Groups

DSI

Division of Scientific Investigations

DSM

Diagnostic and Statistical Manual (of the American Psychiatric Association)

DSMB

Data and Safety Monitoring Board

DSMC

Data and Safety Monitoring Committee

DSNP

development of standardized nomenclature project (FDA)

DSTU

Draft Standard for Trial Use. See HL7 definition .

DSUR

Development Safety Update Report (ICH)

DTC

direct to consumer (drug advertising)

DTD

Document Type Definition (XML)

DUR

Drug Utilization Review

DWI

Diffusion weighted imaging

Dx

Diagnosis

E3C

European CDISC Coordinating Committee

EA

Environmental Assessment

EAB

Ethical Advisory Board

EAB

Editorial Advisory Board (Applied Clinical Trials )

EACR

European Association for Cancer Research

EANO

European Association for NeuroOncology

EBM

Evidence Based Medicine

EBMT

European Group for Blood and Marrow Transplantation

EC

European Commission

EC

Ethics Committee

ECG

Electrocardiogram

ECG

European CDISC Group

ECOG

Eastern Cooperative Oncology Group

ECPHIN

European Community Pharmaceutical Information Network

eCRF

electronic case report form

ECRIN

European Clinical Research Infrastructures Network

eCTD

electronic common technical document

ED

Effective Dose

EDC

Electronic Data Capture

EDC

electronic data capture/collection

EDI

electronic data interchange

eDMS

electronic data management system

EDR

electronic document room. NOTE: The EDR is an extension of the e Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links.

EEG

Electroencephalogram

EER

Establishment Evaluation Request

EFGCP

European Forum for Good Clinical Practice

EFPIA

European Federal of Pharmaceutical Industries Associations

EFS

Event Free Survival time from diagnosis to defined events (eg relapse or deat

eHR

electronic health record

EHS

Environmental Health and Safety

EIA

Establishment Inspection Reports

EICESS

European Intergroup Ewing's Sarcoma Study

EIN

Entity Identification Number

EIR

Establishment Inspection Report

EJC

European Journal of Cancer

ELA

Establishment License Application

ELISA

Enzyme Linked Immunosorbent Assay (test)

ELISpot

Enzyme Linked Immunospot (assay)

EMEA

European Medicines Agency

EMERSE

Electronic Medical Record Search Engine

EMUO

Early Morning Urine Osmolality (evaluating urine concentration)

EMWA

European Medical Writers Association

ENSG

European Neuroblastoma Study Group

ENT

Ear nose throat

EO

Executive Order

EOI

European Osteosarcoma Intergroup

EOP1

End of phase 1

EOP2

End of phase 2

EORTC

European Organisation for Research and Treatment of Cancer

EOS

End of Study

EPA

Environmental Protection Agency

EPAR

European Public Assessment Report

EPL

Effective Patent Life

EPMS

Employee Performance Management System

EPO

European Patent Office; erythropoietin

EPRG

European Pharmacovigilance Research Group

ER

Essential Requirements (EMEA)

ERA

Electronic Research Administration

ERISA

Employee Retirement Insurance Security Act

Erlotinib (Tarceva)

(Tarceva) a drug used to treat locally advanced or metastatic non small cell lung cancer and other cancers. Like gefitinib, it targets epidermal growth factor receptor tyrosine kinase, and specific genetic mutations correlate to patients’ response to the drug.

ERSR

electronic regulatory submissions and review (FDA's e Submissions processing group)

eRX

electronic prescribing

eSDI

electronic Source Data Interchange

ESO

European School of Oncology

ESR

Erythrocyte Sedimentation rate

ESRA

European Society of Regulatory Affairs

ESS

Executive Secretary and Staff

ESTRI

Electronic Standards for the Transfer of Regulatory Information (ICH)

ESTRO

European Society for Therapeutic Radiation and Oncology

ETS

Environmental Tobacco Smoke

ETT

Exercise Tolerance Test

EUDRA

European Union Drug Regulatory Authorities

EudraCT

European Union clinical trials database

EUP

Experimental Use Permit

EUROVAC

European Vaccine Effort Against HIV/AIDS

EVS

Enterprise Vocabulary Services (National Cancer Institute)

EWG

expert working group

F&A Costs

Facilities and Administrative Costs

F/H

Family history

FAB

French American and British classification scheme for leukaemia

FACA

Federal Advisory Committee Act 1972

FAR

Federal Acquisition Regulation

FBC

Full Blood Count

FCCSET

Federal Coordinating Council for Science, Engineering and Technology

FD & C Act

Federal Food, Drug and Cosmetic Act

FDA

Food and Drug Administration (USA)

FDA 1572

FDA Form for Statement of Investigator

FDA 482

Notice of Inspection

FDA 483

Notice of Adverse Findings in an Inspection

FDAAA

Food and Drug Administration Amendment Act (pronounced fedaahh or fedah ah)

FDAMA

FDA Modernization Act

FDA SRS

Spontaneous Reporting System of the Food and Drug Administration

FDCA

Food, Drug, and Cosmetic Act

FDG PET

Fluorodeoxyglucose PET

FDLI

Food and Drug Law Institute

FDP

Federal Demonstration Partnership

FECS

Federation of European Cancer Societies

FEV

Forced expectorant volume (a lung test)

FFA

For Further Appointment

FFDCA

Federal Food, Drug, and Cosmetic Act

FFPM

Fellow of the Faculty of Pharmaceutical Medicine (UK)

FHCRC

Fred Hutchinson Cancer Research Center

FHI

Family Health International

FIC

Fogarty International Center, NIH

FIGO

International Federation of Gynecology and Obstetrics

FIPS

Federal Information Processing Standards

FISH

Flourescence in situ Hybridisation

FMD

Field Management Directives

FMTC

Familial Medullary Thyroid Carcinoma

FNA

Fine Needle Aspiration a type of biposy using a thin needle (or FNAB)

FOI

Freedom of Information

FOIA

Freedom of Information Act

FONSI

Finding of No Significant Impact

FPL

Final Printed Labeling

FPR

Final Proposal Revision

FRC

Federal Records Center (Suitland)

FRCP

Fellow of the Royal College of Physicians, sometimes followed by a place name for example, FRCP (Edin.) that indicates a university medical school

FSIS

Food Safety and Inspection Service

FTE

Full Time Equivalent

FU

Follow up

FUR

Follow up Request

FVC

Forced Vital Capacity

FWA

Federalwide Assurance

g

gram unit of weight

GA

General Anaesthetic

GAO

General Accounting Office

GATT

General Agreement of Tariffs and Trade

GBP

good business practice

Gbps

gigabits, or billions of bits per second (data transmission)

GC

General Counsel (FDA)

GCAB

Global Community Advisory Board

GCP

Good clinical practice

GCRC

General Clinical Research Center

GCRP

good clinical research practice

GDA

Global Disclosure Agreement

GFR

Gromerular filtration rate

GI

Gastrointestinal

GI

Gastrointestinal

GLP

Good Laboratory Practice

GMC

General Medical Council (UK)

GMO

Grants Management Officer

GMP

Good Manufacturing Practice

GOG

Gynecology Oncology Group

GP

general practitioner; general practice (UK)

GPMS

good postmarketing surveillance practice (Japan)

GPOH

Gesellschaft fur Padiatrische Onkologie und Hamatologie (German Paed. Onc Group)

GPR

Good Partial Remission

GPRA

Government Performance and Results Act

GQA

General Qualifying Application

Grade 1 toxicities

mild adverse events.

Grade 3 toxicities

severe adverse events.

Grade 4 toxicities

life threatening or disabling adverse events.

GRAS

Generally Recognized as Safe

GRASE

Generally Recognized as Safe and Effective

GRP

Good Review Practice

GU

Genito urinary

GXP

good (pharmaceutical) practice

Gy

Grays (units of radiation)

H&E

Hematoxylin and Eosin (stain)

H/O

History of

HA

health authority (UK)

HAACP

Hazard Analysis and Critical Control Point (inspection technique)

HAART

Highly Active Antiretroviral Therapy

HAI

Health Action International

HANC

HIV/AIDS Network Coordination

Hb

Haemoglobin

HCFA

Health Care Financing Administration; now renamed The Centers for Medicare & Medicaid Services (CMS).

HCPCS modifier

An HCPCS code descriptor utilized to provide additional information regarding the service or item identified by the HCPCS code, including specific circumstances that may apply to the service or item.

HDC

High Dose Chemotherapy

HEPA

High Efficiency Particulate Air Filter

HEX

Human Experimentation Committee. See also Ethics Committee box in the Glossary.

HF

Routing code for mail to the Office of the Commissioner of the FDA

HFD

Routing code for mail to CDER

HFM

Routing code for mail to CBER

HFS

Routing code for mail to CFSAN

HFT

Routing code for mail to NCTR

HFV

Routing code for mail to CVM

HFZ

Routing code for mail to CDRH

HHS

Health and Human Services (Department of)

HHS

Department of Health and Human Services (U.S., also called DHHS)

HIC

Human Investigation Committee(former name of HSR)

HIE

health information exchange

HIMA

Health Industry Manufacturers Association

HIMSS

Healthcare Information and Management Systems Society (pronounced hymns)

HIPAA

Health Insurance Portability and Accountability Act

HIRE

Human Investigations Involving Radiation Exposure (subcommittee of RSC)

HIT

health information technology

HITSP

Health Information Technology Standards (pronounced hitspee)

HIV

Human Immunodeficiency Virus

HIVNET

HIV Network for Prevention Trials – United States (Closed October 1999)

HL7

Health Level 7 (a not for profit ANSI accredited standards developing/development organization [SDO])

HL A

Human Leukocyte Associated antigens (HL A matching for BMT)

HLA

Human Leucocyte Antigen

HMO

Health Maintenance Organization

HNPCC

Hereditary NonPolyposis Colorectal Cancer

HP

Health Physicist

HPA

Human Protections Administration

HPB

Health Protection Branch, Laboratory Centre for Disease Control (Canada); has been superseded by Health Canada

HPLC

high performance liquid chromatography

HPTN

HIV Prevention Trials Network

HPTU

HIV Prevention Trials Unit

HPV

Human Papilloma Virus implicated in some gynacological cancers

HR

High risk

HRG

Health Research Group

HRRC

Human Research Review Committee

HRSA

Health Resources and Services Administration

HRT

Hormone replacement therapy

HRW

High Risk Women

HSRC

Human Subjects Review Committee. See also Ethics Committee box in the Glossary .

HTLV

Human T cell leukemia lymphoma virus

HTML

Hypertext Markup Language

HTTP

Hypertext Transfer Protocol

HVTN

HIV Vaccine Trials Network

HVTU

HIV Vaccine Trials Unit

HX

History

I3C

India CDISC Coordinating Committee

IAB

Industry Advisory Board (for CDISC)

IACR

International Association of Cancer Registries

IACUC

Institutional Animal Care and Use Committee

IARC

International Agency for Research on Cancer

IASLC

International Association for the Study of Lung Cancer

IAVI

International AIDS Vaccine Initiative

IB

Investigator’s Brochure

IBC

Institutional Biosafety Committee

IC

Informed consent

IC

Chemistry Information Amendment (COMIS term)

IC

informed consent

ICARE

International Cancer Alliance for Research and Education (ICARE)

ICASO

International Council of AIDS Service Organizations

ICCCPO

International Confederation of Childhood Cancer Parent Organisations

ICCG

International Collaborative Cancer Group

ICCPO

Icelandic Childhood Cancer Parent Organisation

ICD

International Classification of Diseases (coding system)

ICD

Informed Consent Document

ICD9

International Classification of Diseases, 9th revision. See also MedDRA.

ICD 9 CM

International Classification of Disease Codes, 9th revision Clinical Modification

ICDO

International Classification of Diseases for Oncology (coding system)

ICF

Intercellular fluid

ICF

informed consent form

ICG

India CDISC Group

ICH

International Conference on Harmonization (GCP)

ICH GCP

ICH Harmonised Tripartite Guideline for Good Clinical Practices

ICLAS

International Council for Laboratory Animal Sciences

ICMJE

International Committee of Medical Journal Editors

ICPEMC

International Commission for Protection Against Mutagens and Carcinogens

ICR

Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK)

ICRF

Imperial Cancer Research Fund (UK)

ICSR

individual case safety report

ICTH

International Committee on Thrombosis and Hemostases

ICTRP

International Clinical Trials Registry Platform (WHO)

ICU

Intensive Care Unit

IDB

Investigational Drug Brochure

IDC

Indirect costs

IDE

Investigational Device Exemption Application to CDRH to get permission for investigational device testing in clinical trials

IDR

Idiosyncratic Drug Reaction

IDS

Investigational Drug Service (pharmacy)

IDSMB

Independent Data Safety Monitoring Board

IDU

Injecting Drug User

IEC

Independent Ethics Committee

IEEE

Institute of Electrical and Electronic Engineers, Inc.

IESS

Intergroup Ewing's Sarcoma Study (USA)

IFAPP

International Federation of Associations of Pharmaceutical Physicians

IFN

Interferon

IFPMA

International Federation of Pharmaceutical Manufacturers and Associations

IG

Inspector General

IG

Immunoglobulin

IHE

Integrating the Healthcare Enterprise (an international standards organization)

IHI

Institute for Healthcare Improvement

IHS

Indian Health Service

IKS

Interkantonale Kontrollstelle für Heilmittel (Switzerland)

IL

Interleukin

IL2

Interleukin2

ILAR

Institute for Laboratory Animal Research

IM

Intramuscular into a muscle

IM

Clinical Information Amendment (COMIS term)

IMI

Innovative Medicines Initiative (European Commission)

IMP

investigational medicinal product; investigational materials plan

IMPAACT

International Maternal Pediatric Adolescent AIDS Clinical Trial Group

IMPD

Investigational Medicinal Product Dossier (EUDRA)

IMRT

Intensity Modulated Radiotherapy

INAD

Investigational New Animal Drug

IND

Investigational new drug

INDA

Investigational New Drug Application

INDC

Investigational New Drug Committee

INFA

International Neurofibromatosis Association

INN

International Nonproprietary Name

INSS

International Neuroblastoma Staging System

Investigational New Drug (IND)

A new molecular, antibiotic, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.

IO

Institutional Official

IOM

Institute of Medicine (National Academy of Science, U.S.)

IOM

Institute of Medicine

IPC

Institutional Participants Committee

IPCS

International Program for Chemical Safety

IPRA

International Product Registration Document

IPRO

Independent Pharmaceutical Research Organization

IPRO

independent pharmaceutical research organization. See also CRO.

IPSO

International Society of Pediatric Surgical Oncology

IRB

Institutional Review Board

IRB HSR

Institutional Review Board Health Sciences Research

IRC

Institutes Review Committee

IRD

international registration document

IRG

Integrated Review Group (NIH peer review)

IRG

Initial Review Groups

IRS

Identical, Related, or Similar

IS

International System of Units (may also be referred to as SI Systéme Internationale)

ISCB

International Society for Clinical Biostatistics

ISDN

Integrated Services Digital Network

ISNCC

International Society of Nurses in Cancer Care

ISO

International Organization for Standardization

ISOQOL

International Society for Quality of Life Research

ISP

Internet service provider

ISPE

International Society for Pharmacoepidemiology

IT

Information Technology

ITCC

Information Technology Coordinating Committee (CDER)

ITU

Intensive Therapy Unit

ITU T

International Telecommunication Union Telecommunication Standardization Sector

IU

International units

IUPAC

International Union of Pure and Applied Chemistry

IV

Intravenous into a vein

IVD

In Vitro Diagnostics

IVP

Intravenous Pyelogram type of Xray after injection with iodine dye

J3C

Japan CDISC Coordinating Committee

JCAH

Joint Commission for the Accreditation of Hospitals

JCAHO

Joint Commission on Accreditation of Health Care Organizations

JCG

Japan CDISC Group

JCO

Journal of Clinical Oncology

J Code

An HCPCS code used to bill payors (such as CMS or insurance companies) for drugs. A J code, as opposed to another letter code (i.e., A code or B code), generally signifies an injectable drug that cannot be self administered.

JCPT

Journal of Clinical Pharmacology and Therapeutics

JCRDD

Journal of Clinical Research and Drug Development

JCRP

Journal of Clinical Research and Pharmacoepidemiology

JMA

Japan Medical Association

JPA

Joint Personnel Agreement

JPMA

Japan Pharmaceutical Manufacturers Association

K+

Potassium

Kbps

kilobits, or thousands of bits per second (data transmission)

kg

Kilogram a thousand grams

LAB

Laboratory Data Model (CDISC)

LATA

Laboratory Animal Training Association

LCH

Langerhans cell histiocytocis

LCIS

Lobular Carcinoma In Situ type of breast cancer

LD

Lethal Dose

LD50

Lethal Dose (50%)

LDH

Lactic dehydrogenase high levels correlate with tumour volume in some cancers

LEAA

Law Enforcement Assistance Administration

LERN

Library Electronic Reference Network

LIF

Swedish Pharmaceutical Industry Association

LKP

Leiter der Klinischen Prüfung

LMP

Low Malignant Potential (context: ovarian tumours)

LN

Lymph Node

LNC

Labeling and Nomenclature Committee

LOC

Level of Concern

LOCF

Last Observation Carried Forward

LOINC

logical observations, identifiers, names, and codes

LP

Lumbar puncture

LPP

Local Partnership Project

LRC

Lipid Research Clinic

LREC

Local Research Ethics Committee (UK)

LRF

Leukaemia Research Fund (UK)

LRFA

Lymphoma Research Foundation of America

LRI

Lower Respiratory Infection

LTE

Less Than Effective

LVEF

Left Ventricular Fjection Fraction a heart function test

Lx

Lumpectomy

m

meter (unit of length)

M/H

Medical history

MA

marketing authorization

MAA

Marketing Authorisation Application (EMEA, EU)

MAB mAb

Monoclonal antibody

MACS

Multi center AIDS Cohort Studies

MAH

Marketing Authorisation Holder (EU)

MAPP

Manual of Policy and Procedures

MBC

Minimum Bactericidal Concentration

MBE

Minority Business Enterprise

Mbps

megabits, millions of bits per second (data transmission)

MCA

Medicines Control Agency (UK)

MDI

Metered Dose Inhaler

MDR

Multi drug resistant

MDR

Medical Device Reporting

MDS

Myelo dysplastic syndrome

MedDRA M

Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others)

MedID

Medicinal Product Identifier

MEDLARS

Medical Literature Analysis and Retrieval System

MEDWATCH

MEFA

Association of the Danish Pharmaceutical Industry

MEN

Multiple Endocrine Neoplasia (familial) a.k.a. FMEN

mEq/l

milliequivalent per liter

MERIT

Method to Extend Research in Time award (NIH)

mets

Metastases (where the tumour has spread to secondary sites)

Mg

Magnesium

MHC

Major Histocompatibility Complex

MHLW

Ministry of Health, Labor and Welfare (Japan)

MHRA

Medicines and Healthcare products Regulatory Agency (UK)

MHW

Ministry of Health and Welfare (Japan's equivalent to the FDA)

MI

Miocardial Infarction

MI

Myocardial Infarction

MIAME

minimum information about a microarray experiment (standard for microarray data)

mIBG

Radioactive Iodine Metaidobenzoguanidine (mIBG scans or mIBG therapy).

MIC

Minimum Inhibitory Concentration

ml

millilitre 0.001 liter

MM

Malignant Melanoma

MMR

Minor Modification Review

MO

Medical Officer

MOH

Ministry of Health (UK, Canada, others)

MOP

Manual of Operations

MOPH

Ministry of Public Health (Thailand, Yemen, others)

mOsm

milliosmole

MPCC

Medical Policy Coordinating Committee (CDER)

MPNST

Malignant Peripheral Nerve Sheath Tumour

MPR

Medical Products Agency (Swedish Regulatory Agency)

MQSA

Mammography Quality Standards Act

MR

Medical Representative (Japan)

MRA

Magnetic resonance angiography

MRA

Medical Research Associate

MRC

Medical Research Council (UK)

MREC

Multi centre Research Ethics Committee (UK)

MRgFUS

MR guided focused ultrasound

MRI

Magnetic resonance imaging

MRSI

Magnetic resonance spectroscopic imaging

MRT

Malignant Rhabdoid Tumour

MSM

Men who have Sex with Men

MSSU

Mid stream specimen urine

MTA

Material Transfer Agreement

MTD

Maximum Tolerated Dose

MTDC

Modified Total Direct Costs

MTN

Microbicide Trials Network

MTPCI

Multidisciplinary Training Program in Clinical Investigations

MUD

Matched Urelated Donor for bone marrow transplant

MVP

master validation plan

Mx

Mastectomy

N/V

Nausea and vomiting

NA

Not Approvable

Na+

Sodium

NAACCR

North American Association of Central Cancer Registries

NABCO

National Alliance of Breast Cancer Organizations

NABR

National Association for Biomedical Research

NABTT

New Approaches to Brain Tumor Therapy

NAD

No Abnormality Detected

NADA

New Animal Drug Application

NAF

Notice of Adverse Findings

NAHC

National Advisory Health Council

NAI

No Action Indicated

NAS

National Academy of Sciences

NAS

new active substance (UK)

NAS

National Academy of Sciences –National Research Council (U.S.)

NBAC NRC

National Bioethics Advisory Commission

NBAC

National Bioethics Advisory Commission (U.S.)

NBCCS

Nevoid basal cell carcinoma syndrome

NBM

Nil by mouth

NCA

national competent authority

NCCAM

National Center for Complementary and Alternative Medicine, NIH

NCCF

National Childhood Cancer Foundation (USA)

NCCLS

National Committee for Clinical Laboratory Standards

NCCTG

North Central Cancer Treatment Group

NCE

No Cost Extension

NCE

New Chemical Entity

NCHS

National Center for Health Statistics

NCI

National Cancer Institue (USA)

NCI LSS

National Cancer Institute Lung Screening Study

NCIA

National Cancer Imaging Archive

NCIC

National Cancer Institute of Canada

NCI CIRB

National Cancer Institute Central Institutional Review Board

NCI

National Cancer Institute

NCI PCIRB

Nat. Cancer Inst.. Pediatric Central Inst. Review Board

NCMHD

National Center for Minority Health and Health Disparities, NIH

NCPF

National Cancer Policy Forum

NCRA

National Cancer Registrars Association (USA)

NCRN

National Cancer Research Network

NCRR

National Center for Research Resources, NIH

NCS

Networking and Communications Subcommittee

NCS

Not Clinically Significant

NCTR

National Center for Toxicological Research

NCVIA

National Childhood Vaccine Injury Act (1986)

NDA

New Drug Application

NDE

New Drug Evaluation

NDS

New Drug Study

NECCR

North of England Children's Cancer Research Unit

NED

No evidence of disease

NEFARMA

Dutch Association of the Innovative Pharmaceutical Industry

NEI

National Eye Institute, NIH

NEJM

New England Journal of Medicine

NF

National Formulary

ng

nanogram 0.000000001 gram

NGA

Notice of Grant Award

NGO

Non Governmental Organization

NHGRI

National Human Genome Research Institute, NIH

NHI

National Health Insurance (Japan)

NHIN

National Health Information Network

NHL

Non Hodgkin's Lymphoma

NHLBI

National Heart, Lung, and Blood Institute

NHS

National Health Service (UK)

NHVREI

NIAID HIV Vaccine Research Education Initiative

NHW

National Health and Welfare Department (Canada's equivalent of DHHS)

NIA

National Institute on Aging, NIH

NIAAA

National Institute on Alcohol Abuse and Alcoholism, NIH

NIAID

National Institute of Allergy and Infectious Diseases, NIH

NIAID

National Institute of Allergies and Infectious Diseases (NIH)

NIAMS

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)

NIAMSD

National Institute of Arthritis and Musculoskeletal and Skin Diseases

NIBIB

National Institute of Biomedical Imaging and Bioengineering, NIH

NICHD

National Institute of Child Health and Human Development, NIH

NICHD

National Institute of Child Health and Human Development (NIH)

NIDA

National Institute of Drug Abuse, NIH

NIDCD

National Institute on Deafness and Other Communication Disorders, NIH

NIDCD

National Institute of Deafness and other Communication Disorders

NIDCD

National Institute on Deafness and Other Communication Disorders (NIH)

NIDCR

National Institute of Dental and Craniofacial Research, NIH

NIDCR

National Institute of Dental and Craniofacial Research (NIH)

NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases, NIH

NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases (NIH)

NIDDKD

National Institute of Diabetes And Digestive And Kidney Diseases

NIDR

National Institute of Dental Research

NIEHS

National Institute of Environmental Health Services, NIH

NIGMS

National Institute of General Medical Sciences, NIH

NIH

National Institutes of Health

NIH NRSA

National Research Service Award

NIMH

National Institute of Mental Health, NIH

NINDS

National Institute of Neurological Disorders and Stroke, NIH

NINR

National Institute of Nursing Research (NIH)

NIOSH

National Institute for Occupational Safety and Health, CDC

NIRB

noninstitutional review board, also known as an independent review board. See also Ethics Committee in the Glossary, NIRB.

NK

Natural Killer cells (large lymphocytes, part of the immune system)

NKA

No Known Allergies

NKCA

National Kidney Cancer Association (USA)

NLEA

Nutrition Labeling and Education Act (1990)

NLM

National Library of Medicine, NIH

NLST

National Lung Screening Trial

NME

New Molecular Entity

NMR

Nuclear Magnetic Resonance

NMSC

Non Melanoma Skin Cancer

NNFF

National Neurofibromatosis Foundation (USA)

NOAEL

no observed adverse effect level (IUPAC)

NOEL

No Observed Effect Level

Non Mem

Non linear Nixed Effect Model

NORD

National Organization for Rare Disorders (USA)

NOS

Not otherwise specified (see ICDO)

NPC

Nasopharyngeal Carcinoma

NR

No Reply Necessary (COMIS term)

NRB

noninstitutional review board, also known as an independent review board

NRC

Nuclear Regulatory Commission

NRC

National Research Council

NRCT

National Registry of Childhood Tumours (UK) held by the CCRG at Oxford

NRSA

National Research Service Award (NIH)

NRSTS

Non Rhabdomyosarcoma Soft Tissue Sarcoma

NSABP

National Surgical Adjuvant Breast and Bowel Project

NSAID

Nonsteroidal Anti inflammatory Drug

NSCLC

Non–small cell lung cancer

NSE

Neuron Specific Enolase a neural marker

NSF

National Science Foundation

NSR

Non significant result

NSR

Nonsignificant Risk

NTP

National Toxicology Program

O/E

On Examination

OAI

Official Action Indicated (serious FDA postinspection classification)

OAR

Office of AIDS Research (NIH)

OARAC

Office of AIDS Research Advisory Committee

OASH

Office of the Assistant Secretary for Health

OB GYN

Obstetrics Gynecology

OC

Office of Compliance (CDER)

OCD

Office of the Center Director (CDER)

OCGR

Office of Communications and Government Relations (NIAID)

OCPB

Office of Clinical Pharmacology and Biopharmaceutics (CDER)

OD

Right Eye

ODAC

Oncologic Drugs Advisory Committee (U.S.)

ODB

Observational Database

ODE

Office of Drug Evaluation (CDER)

ODM

Operational Data Model (CDISC)

OEB

Office of Epidemiology and Biostatistics (CDER)

OECI

Organization of European Cancer Institutes

OEHS

Office of Environmental Health and Safety

OGA

Office of Grants and Contracts Administration

OGD

Office of Generic Drugs (CDER)

OHA

Office of Health Affairs

OHITA

Office of Health Information Technology Adoption (ONCHIT)

OHRM

Office of Human Resource Management

OHRP

Office for Human Research Protections

OIG

Office of the Inspector General

OIS

Office of Interoperability and Standards

OJC

Official Journal of the European Union–C Series (Information)

OJEC

Official Journal of the European Communities

OJL

Official Journal of the European Union–L Series (Legislation)

OLAW

Office of Laboratory Animal Welfare (NIH)

OM

Office of Management (CDER)

OMB

Office of Management and Budget

ONB

Olfactory Neuroblastoma

ONCHIT

Office of the National Coordinator for Health Information Technology (HHS)

ONDC

Office of New Drug Chemistry (CDER)

ONR

Office of Naval Research

ONS

Oncology Nursing Society (USA)

OPCRO

Office for Policy in Clinical Research Operations

OPERA

Office of Policy for Extramural Research Administration (NIH)

OPR

Office of Policy and Research

OPRR

Office of Protection for Research Risks

OPS

Office of Pharmaceutical Science (CDER)

ORA

Office of Regulatory Affairs

ORAGS

Office of Research and Graduate Studies, UMB School of Medicine

ORI

Office of Research Integrity

ORM

Office of Review Management (CDER)

ORO

Office of Regional Operations

ORWH

Office of Research on Women’s Health (NIH)

OS

Overall Survival

OS

Left Eye

OSHA

Occupational Safety Health Administration

OSP

U.Va. Office of Sponsored Programs

OTA

Office of Technology Assessment

OTA

Office of Technology Assessment (U.S., abolished 1995)

OTC

Over the Counter Drugs

OTC

Over the counter (non prescription drugs)

OTC

over the counter (refers to nonprescription drugs)

OTCOM

Office of Training and Communications (CDER)

OTR

Office of Testing and Research (CDER)

OU

Both Eyes

OVCR

Office of the Vice Chancellor for Research

PA

Program Announcement (in context of funding searches)

PAB

Pharmaceutical Affairs Branch

PAHO

Pan American Health Organization

PAIR

Patient Advocates in Research

PAITS

Pre Approval Inspection Tracking System

PAR

Postapproval Research

PAVE

Partners for AIDS Vaccine Evaluation

PBSC

Peripheral Blood Stem Cell (see PBSCT)

PBSCH

Peripheral Blood Stem Cell Harvest

PBSCR

Peripheral Blood Stem Cell Rescue (transplant)

PBSCT

Peripheral Blood Stem Cell Transplant

PBTC

Pedi Brain Tumor Consortium

PC

Personal Computer

PCC

Parklawn Computer Center

PCC

Poison Control Center

PCP

Pneumocystis carinii pneumonia

PCR

Polymerase Chain Reaction

PD

Progressive disease

PD

Pharmacodynamics

PDA

Parenteral Drug Association

PDA

personal digital assistant (Palm Pilot, for example)

PDC

Protocol Development Coordinator

PDF

portable document format

PDQ

Physician's Data Query (CancerNet)

PDR

Physician's Desk Reference

PDRC

Protocol Development and Regulatory Compliance

PDUFA

Prescription Drug User Fee Act of 1992

PE

Physical Examination

PEM

prescription event monitoring

PEP

Performance Evaluation Plan

PERI

Pharmaceutical Education & Research Institute (not for profit division of PhRMA)

PET

Positron Emmission Tomography a scan after a small radioactive injection.

PFS

Progression Free Survival

PFT

Pulmonary Function Tests

PFT

pulmonary function test

pg

picogram 0.000000000001 gram

PGT

pharmacogenetics

PGX

pharmacogenomics

pH

hydrogen ion concentration acid / alkaline

Phase I trial

A clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed.

Phase II trial

A clinical trial in which the safety and preliminary efficacy of an intervention are assessed.

Phase III trial

A large scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market.

Phase IV trial

A large scale trial undertaken after FDA approval for safety surveillance to detect rare or long term adverse events. Also known as a post marketing surveillance trial.

PHI

Protected health information

PHI

Protected Health Information

PHI

Protected Health Information

PhPID

pharmaceutical product identifier

PhRMA

Pharmaceutical Research and Manufacturers of America

PhRMA

Pharmaceutical Research and Manufacturers of America

PHRP

Partnership for Human Research Protection, Inc.

PHS

Public Health Service

PHS

Public Health Service

PHS2590

Refers to the form used for noncompeting continuation applications to the NIH

PHS398

Refers to the form used for new and competing renewal applications to the NIH

PI

Principal Investigator

PI

Package Insert (approved product labeling)

PIM

product information management (a system introduced by the EMEA)

PK

Pharmacokinetics

PLA

Patent License Agreement

PLA

Product License Application (when seeking commercialization of a biologic)

PLA/ELA

Product License Application/Establishment License Application

PLWA

Person Living With AIDS

PM

Project Manager

PMA

Pre Market Approval (when seeking commercialization of a device)

PMCC

Project Management Coordinating Committee (CDER)

PMDIT

Project Management

PMS

Postmarketing Surveillance

PN

Protocol Amendment New Protocol (or Pending Review) (COMIS term)

PNET

Primitive neuroectodermal tumour Context: CNS tumours

PNS

Peripheral nervous system nervous system outside the brain and spine.

PO

Purchase Order

PO

Per Os (by mouth)

POG

Pediatric Oncology Group (USA)

PONF

Paediatric Oncology Nurses Forum (UK)

PPA

Poison Prevention Act

PPE

Personal Protective Equipment

PPI

Patient Package Insert

PPO

Policy and Procedure Order

PPO

Preferred Provider Organization

PR

Partial Responce / Partial Remission

PR

Pulse Rate

PRC

Protocol Review Committee U.Va. Cancer Center

PRG

Protocol Representation Group (CDISC)

PRIM & R

Public Responsibility in Medicine and Research

prn

as required

PRN

As Needed

PRO

patient reported outcome

Process map

A visual representation of a workflow comprising a stream of activities that transforms a well defined input or set of inputs into a pre defined set of outputs.

PROG

Peer Review Oversight Group (NIH)

PROMIS

Patient Reported Outcomes Measurement Information Systems (pronounced promise)

Protocol

A study plan on which a clinical trial is based. The plan is designed to safeguard the health of participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

PRT

Primary Review Team

PSA

Protocol specific Application

PSRC

Prevention Sciences Review Committee

PSUR

periodic safety update report

PTAO/PTAEO

Project Task Award Office

PTC

points to consider

PTCC

Pharmacology/Toxicology Coordinating Committee (CDER)

PTN

(see HPTN)

PTV

Primary tumor volume

PV

pharmacovigilance

PWA

Person With AIDS

QA

Quality Assurance

QALY

Quality Adjusted Life Year

QARC

Quality Assurance Review Center

QAU

Quality Assurance Unit

QC

Quality Control

QD

Once Daily

qid

Four times a day (quater in die)

QL

Quality of Life

QNS

Quantity Not Sufficient

QOD

Every Other Day

QoL

Quality of Life

QOL

quality of life (also QoL)

R & D

Research and Development

RA

Research Associate

RAB

Regulatory Affairs Branch (DAIDS)

RAC

Reviewer Affairs Committee (CDER)

RADAR

Risk Assessment of Drugs Analysis and Response

RAPS

Regulatory Affairs Professionals Society

RBC

Red blood cell / red blood count

RC

Research Coordinator

RCC

Research Coordinating Committee (CDER)

RCC

Regulatory Compliance Center (DAIDS)

RCH

Remove Clinical Hold

RCR

Responsible Conduct of Research

RCRA

Regional Clinical Research Associate

RCRIM

Regulated Clinical Research Information Management, a technical committee of HL7 with responsibility for developing technical standards for the exchange and management of health research information to be submitted to regulatory authority(ies)

RCT

Randomized Clinical Trial

RD

Response to Request for Information (COMIS term)

RDE

Remote Data Entry

RDRC

Radioactive Drug Research Committee

RDT

Rising dose tolerance

REB

research ethics board (Canada)

REMS

Risk Evaluation and Mitigation Strategy (FDA, in FDAAA)

RFA

Radiofrequency ablation

RFD

retrieve form for data capture

RFP

Request for Proposals (Contracts)

RFQ

Request for Quote

RHIO

regional health information organization

RIF

Reduction In Force

RIGS

Radioimmunoguided surgery

RIM

Reference Information Model (HL7)

RKI

Robert Koch Institut, Bundesinstitut für Infektionskrankheiten und nich übertragbare Krankheiten (Federal Institute for Infectious and Noncommunicable Diseases, Germany)

RL

Regulatory Letter

RMO

Regulatory Management Officer

RMS

Rhabdomyosarcoma

RMW

Regulated Medical Waste

ROC

Receiver operating characteristic

ROE

Report of Expenditures

RPE

Radiation Producing Equipment

RPS

Regulated Product Submission (HL7 RCRIM)

RSC

Radiation Safety Committee

RSO

Radiation Safety Officer

RT

Radiotherapy

RTF

Refuse To File

RTOG

Radiation Therapy Oncology Group

RTPCR

Reverse transcriptase polymerase chain reaction

RUG

Resource Utilization Group

Rx

Treatment

S

Standard

SA

Surface area (see BSA)

SAAVI

South African AIDS Vaccine Initiative

SACHRP

Secretary's Advisory Committee on Human Protection. See also OHRP .

SADR

suspected adverse drug reaction (FDA)

SAE

Serious adverse event

SAG

Science Administration Group

SAL

Sterility Assurance Level

SAS

Statistical Analysis System (commonly used statistical analysis package)

SATCM

State Administration of Traditional Chinese Medicine (China)

SBA

Summary Basis of Approval

SBIR

Small Business Innovation Research Grant

SBS IRB

Social and Behavioral Sciences Institutional Review Board

SC

Subcutaneous

SC

Study Coordinator

SCAW

Scientists Center for Animal Welfare

SCDM

Society for Clinical Data Management

SCHARP

Statistical Center for HIV AIDS Research and Prevention

SCLC

Small cell lung cancer

SCSO

Supervisory Consumer Safety Officer

SCT

Society for Clinical Trials

SCTN

Scottish Cancer Therapy Network

SD

Stable Disease

SD

Standard Deviation

SD

Source Document

SDA

State Drug Administration (China)

SDM

Submission Data Model (CDISC)

SDMC

Statistical and Data Management Center

SDO

standards development organization

SDS

Submission Data Standards (CDISC)

SDTM

Study Data Tabulation Model (CDISC)

SDV

Source Data Verification

SDV

source document (data) verification

SE

Standard Error

SE

standard error (statistics)

SEA

Single European Act of 1987

SEER

Surveillance, Epidemiology, and End Results (Registry of NCI)

SEG

Special Emphasis Group (Laboratory)

SEND

Standard for the Exchange of Nonclinical Data. NOTE: The focus of the SEND Team is on data collected from animal toxicology studies. [CDISC]

SES

Senior Executive Service

SF

Standard Form (Federal)

SFOP

French Paediatric Oncology Scociety

SGDM

Study Group on Data Management (EORTC)

SGML

Standard Generalized Markup Language

SGO

Society of Gynecologic Oncologists

SGOT

Serum glutamic oxalacetic transaminase a liver function test

SGPT

Serum glutamic pyruvic transaminase a liver function test

SHIV

Simian Human Immunodeficiency Virus

SHO

Senior House Officer

SIAC

Special Interest Area Community (DIA)

SIG

Special Interest Group (HL7)

SIOP

International Society of Paediatric Oncology

SIV

Simian Immunodeficiency Virus

SLA

service level agreement

SMART

Submission Management and Review Tracking

SMDA

Safe Medical Devices Act (1990)

SME

Significant Medical Event

SMO

Site Management Organization

SmPC

summary of product characteristics. See also SPC.

SNAP

Streamlined Noncompeting Award Process (NIH)

SNDA

Supplemental New Drug Application

SNIP

Syndicat National de l'Industrie Pharmaceutique (France)

SNLG

Scottish and Newcastle Lymphoma Group

SNOMED

Systematized Nomenclature of Medicine (a dictionary)

SNP

Single Nucleotide Polymorphism

SOAP

simple object access protocol (a W3C XML initiative)

SOB

Short of breath

SoCRA

Society of Clinical Research Associates

SOM

School of Medicine

SOMCTO

School of Medicine Clinical Trials Office

SOMOGC

School of Medicine Office of Grants and Contracts Administration

SON

School of Nursing

SOP

Standard operating procedure

SOW

Scope of Work

SPAC

State Pharmaceutical Administration of China

SPC

summary of product characteristics. See also SmPC.

SPL

Structured Product Labeling (HL7, FDA)

SPM

Society of Pharmaceutical Medicine (UK)

SPOHNC

Support for People with Oral and Head and Neck Cancer

SPORE

Specialized Programs of Research Excellence

SQ

Subcutaneous

SQA

Society of Quality Assurance

SQAP

systems quality assurance plan

SRA

Society of Research Administrators

SRA

Staff Research Associate

SRS

Spontaneous Reporting System

SSC

Scientific Steering Committee (HVTN)

SSC

study site coordinator. See also CRC, CCRC, SC.

SSCT

Swedish Society for Clinical Trials

SSFA

Società di Scienze Farmacologiche Applicate (Italy)

SSM

Superficial Spreading Melanoma

SSM

Skin Surface Microscopy

STD

Sexually Transmitted Disease

STF

study tagging file

STI

Sexually Transmitted Infection

STT

Short Term Tests

STTR

Small Business Technology Transfer Grant

SUAE

serious unexpected adverse event

SUD

sudden unexpected death

SUPAC

Scale up and post approval changes

SWG

Strategic Working Group

SWOG

Southwest Oncology Group

SX

Symptoms

TAC

Technical Advisory Committee (CDISC)

TAMs

tumour associated macrophages

TBI

Total body irradiation

TC

Technical Committee (HL7)

TCC

Transitional Cell Carcinoma (usually bladder cancer)

TCP

Thrombocytopenia

TCP/IP

Transmission Control Protocol/Internet Protocol

TDC

Total Direct Costs

tds / tid

Three times a day (ter in die)

TESS

treatment emergent signs and symptoms

TID

Three Times A Day

TIND

Treatment IND

TK

Toxicokinetics

Tmax

the time after dosing when Cmax occurs

TMO

trial management organization

TNF

Tumour Necrosis Factor

TNM

Staging system primary tumour

TOP

Topical

TPN

total parenteral nutrition

TRK

Transketolase

TSH

Thyroid Stimulating Hormone

UA

Urinalysis

ug

microgram 0.000001 gram

UICC

Union Internationale Contre le Cancer International Union Against Cancer

UKACR

UK Association of Cancer Registeries

UKCCCR

UK Coordinating Committee for Cancer Research

UKCCR

United Kingdom Coordinating Committee on Cancer Research

UKCCRG

UK Children's Cancer Research Group (Oxford)

UKCCSG

UK Children's Cancer Study Group (UK)

ULN

Upper Limits of Normal

UMMS

University of Maryland Medical System

UMT

universal mean time (also known as Greenwich mean time). See UTC.

UNAIDS

Joint United Nations Programme on HIV/AIDS

UNESCO

United Nations Educational Science and Cultural Organization

UNK

Unknown

URL

uniform resource locator (address of a Web site)

URTI

Upper respiratory tract infection

US

Ultrasound (scan)

USAN

United States Adopted Name

USDA

United States Department of Agriculture

USMHRP

U.S. Military HIV Research Project

USP

U.S. Pharmacopeia

USPC

U.S. Pharmacopeial Convention

USP DI

United States Pharmacopeia Drug Information

USPIO

Ultrasmall particle superparamagnetic iron oxide

USP NF

United States Pharmacopeia National Formulary

UST

user site testing. Synonym for UAT (user acceptance testing)

USUHS

Uniformed Services University of the Health Sciences

UTI

Urinary Tract Infection

UVR

Ultra Violet Radiation

VA

Department of Veteran’s Affairs (Federal)

VAERS

Vaccine Adverse Event Reporting System

VAI

Voluntary Action Indicated

VAI

Voluntary Action Indicated (FDA postaudit inspection classification)

VAI

Voluntary Action Indicated (post FDA audit inspection classification)

Value stream mapping

a lean process visualization technique used to analyze the flow of materials and information through a system. The goal of value stream mapping is to understand and streamline the work processes by reducing waste, or activities that do not add value.

VCDE

vocabularies and common data elements (caBIG)

VDGIF

Virginia Dept. of Game and Inland Fisheries

VEF

Ventricular ejection fraction (tests lung function)

VGDS

voluntary genomic data submission

VIEW

Virtual Imaging Evaluation Workspace

VM 26

Teniposide (anti cancer drug)

VMA

Vanillylmandelic Acid

VP 16

Etoposide (anti cancer drug)

VPRP

Vaccine and Prevention Research Program (DAIDS)

VRC

Dale and Betty Bumpers Vaccine Research Center (NIAID/NIH)

VS

Vital Signs

VTN

(see HVTN)

WBC

White blood cell count

WCC

White cell count

WD

Withdrawn (COMIS term)

WHO

World Health Organization

WHOART

World Health Organization Adverse Reaction Terminology

WI

Inactive (COMIS term)

WIHS

Women's Interagency HIV Study (DAIDS)

WITS

Women and Infants Transmission Study (DAIDS)

WL

Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days)

WNL

Within Normal Limits

WOCBP

Women of Child Bearing Potential

WR

written request

WRAIR

Walter Reed Army Institute of Research

WTO

World Trade Organization

WVA

World Veterinary Association

WWW

World Wide Web

XIP

EXtensible Imaging Platform

XML

eXtensible Markup Language

XRT

Radiotherapy (external)

YST

Yolk sac tumour (aka. germ cell tumour)