Liste restreinte d'acronymes couramment utilisés en recherche clinique

Dernière mise à jour: Août 17, 2026

 

Liste restreinte d'acronymes couramment utilisés en recherche clinique

700U Statement of Economic Interest

ACRP Association of Clinical Research Professionals

AE Adverse Event

ADR Adverse Drug Reaction

AMA American Medical Association

BID Twice Daily

BIND BiologicalIND

CAP Collegeof American Pathologists

CBCTN Community Based Clinical Trials Network

CBER Centerfor Biologics Evaluation and Research (FDA)

CCRA Certified Clinical Research Associate (ACRP)

CCRC Certified Clinical Research Coordinator (ACRP)

CCRC CTSC ClinicalResearchCenter

CCRP Certified Clinical Research Professional (SoCRA)

CDA Confidential Disclosure Agreement

CDC Centerfor Disease Control

CDER Centerfor Drug Evaluation and Research (FDA)

CDRH Centerfor Devices and Radiological Health (FDA)

CF Consent Form

CFR Code of Federal Regulations

CLIA Clinical Laboratory Improvement Amendments

CME Continuing Medical Education

CP Compliance Program (FDA)

COI Conflict of Interest

CRA Clinical Research Associate CTSC Clinical Research Training Program

CRC Clinical Research Coordinator

CRF Case Report Form

CRO Clinical Research Organization

CT Clinical Trial

CTA Clinical Trial Agreement

CS Clinically Significant

CSA Clinical Service Agreement

CTSC Clinical and TranslationalScienceCenter

CV Curriculum Vitae

DCF Data Correction Form / Data Clarification Form

DEA Drug Enforcement Agency (division d'application de la loi de la FDA)

DHHS Department of Health & Services à la personne

DOS Description of Study

EAB Ethical Advisory Board (similaire à l'IRB, used by other nations)

EDC Electronic Data Capture

FDA Food and Drug Administration

FDA-482 Notice of Inspection

Avis FDA-483 de résultats anormaux lors d’une inspection

FDA-1572 FDA Form for New Drug Application

FDA-1572 FDA Form for Statement of Investigator

FDA-SRS Spontaneous Reporting System of the FDA

FDCA Food, Médicament, et loi cosmétique

FOIA Freedom of Information Act

FTC Federal Trade Commission

GCP Good Clinical Practice

GDA Global Disclosure Agreement

GLP Good Laboratory Practice CTSC Clinical Research Training Program

 

GMP Good Manufacturing Practice

HIPAA Health Insurance Portability and Accountability Act

HHS Health and Human Services (Department of)

HMO Health Maintenance Organization

IACUC Institutional Animal Care and Use Committee (IRB à usage animal)

IB Investigator’s Brochure

 

Formulaire de consentement éclairé de l'ICF

Conférence internationale de l'ICH sur l'harmonisation

IDB Investigational Drug Brochure

IDE Investigational Device Exemption

IDS Investigational Drug Service (pharmacy)

INAD – nouveau médicament expérimental pour animaux (FDA)

INDInvestigational New Drug

Comité d'examen institutionnel de la CISR

Commission mixte JCAHO d'accréditation des établissements de soins de santé

Lettre d'accord de LOA

Rapports sur les dispositifs médicaux MDR

Protocoles d'entente

Associé de recherche médicale MRA

IAN Aucune action Indication (classification d'inspection post-FDA la plus favorable)

Institut national du cancer NCI

NCS Not Clinically Significant

Demande de drogue nouvelle NDA

NHLBI National Heart, Poumon, and Blood Institute

Programme de formation à la recherche clinique du NIAID National Institute of Allergy and Infectious Diseases CTSC

 

NIH National Institutes of Health

NIMH National Institute of Mental Health

NKA No Known Allergies

Action officielle de l’OAI indiquée (classification sérieuse d'inspection post-FDA)

Bureau de l'OHRP pour la protection de la recherche humaine

OSHA Occupational Safety and Health Administration

OTC de gré à gré (médicaments sans ordonnance)

OVCR Bureau du vice-chancelier à la recherche

PCCPoisonControlCenter

PD Pharmacodynamics

PDQ Physician’s Data Query (NCI sponsored cancer trial registry)

PDR Physician’s Desk Reference

PE Physical Examination

PHI Protected Health Information

Notice d'emballage PI

Chercheur principal PI

Pharmacocinétique PK

Demande de licence de produit PLA (lorsqu'on cherche à commercialiser un produit biologique)

PMA Pre-Market Approval (when seeking commercialization of a device)

POBy Mouth

PPE Personal Protective Equipment

PPI Patient Package Inserts

PPO Preferred Provider Organization

PRN As Needed

QA Quality Assurance

Contrôle qualité CQ

Programme de formation quotidien en recherche clinique QD CTSC

 

QID Four Times a Day

QOL Quality of Life

R.&D Recherche et Développement

RDE Remote Data Entry

Lettre réglementaire RL (lettre d'audit post-FDA)

réception. Ordonnance

Événement indésirable grave SAE

Coordinateur d'études SC

Document source SD

Organisation de gestion du site SMO

SoCRA Society of Clinical Research Associates

SOMSchoolof Medicine

Procédure opérationnelle standard SOP

Associé de recherche du personnel de la SRA

TID Three Times a Day

UNK Unknown

USPU.S.Pharmacopeia

VAUnited StatesDepartment of Veterans Affairs

VAI Voluntary Action Indicated (post-FDA audit inspection classification)

VS Vital Signs

OMS Organisation Mondiale de la Santé

Lettre d'avertissement WL