Clinical Research Glossary

Below is a list of commonly used terms in clinical research and an explanation of each.

510(k) Medical Device Submissions Requirements (FDA)
ABPI Association of the British Pharmaceutical Industry
ACRPI Association for Clinical Research in the Pharmaceutical Industry – changed its name to ICR–Institute of Clinical Research
ADE Adverse Drug Event; Adverse Drug Effect
ADME Absorption, Digestion, Metabolism & Excretion – (used to describe pharmacokinetic processes)
ADR Adverse Drug Reaction
AE Adverse Event
BARQA British Association of Research Quality Assurance
CA Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations)
CDA Confidentiality Agreement
CFR Code of Federal Regulations
CI Chief Investigator
CIOMS Council for International Organisations of Medical Sciences (post-approval international ADR reporting, UK)
Cmax Concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug
CPMP Committee for Proprietary Medicinal Products (now known as CHMP – Committee for Medicinal Products for Human Use)
CRA Clinical Research Associate
CRF Clinical Record Form/Case Report Form
CRO* Clinical Research Organisation
CRO* Contract Research Organisation
CSR Clinical Study Report
CTA* Clinical Trial Associate
CTA* Clinical Trial Authorisation
CTA* Clinical Trial Agreement
CTC Clinical Trial Certificate (now incorporated into the CTA)
CTD* Clinical Trial Directive
CTD* Common Technical Document
CTMS Clinical Trial Management System
CTX Clinical Trials Exemption Certificate (now incorporated into the CTA)
CV Curriculum Vitae
DCF Data Clarification Form
DDI Drug-Drug Interaction
DDX Doctors and Dentists Exemption Certificate (now incorporated into the CTA)
DLT Drug Limiting Toxicity
DM Data Management
DMC Data Monitoring Committee
DMEC Data Monitoring and Ethics Committee
DoH Department of Health (UK)
Double Blind A trial where neither the participants nor the researchers know who belongs to the control group and the experimental group. A double blind trial is a way to lessen the potential for bias on the results.
DQF Data Query Form
DSMB Data Safety Monitoring Board
EC European Commission
eCRF Electronic Case Report Form
EDC Electronic Data Capture
EMEA European Medicines Agency
EMWA European Medical Writers Association
EU European Union
EU CTD European Union Clinical Trial Directive
EudraCT European Clinical Trial Database
EudraVIGILANCE European Database for Pharmacovigilance
FDA Food & Drug Administration (USA)
GAfREC Governance Arrangements for Research Ethics Committees
GCP Good Clinical Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
IB Investigator’s Brochure
ICF Informed Consent Form
ICH GCP International Conference on Harmonisation Good Clinical Practice
ICR Institute of Clinical Research
IMP Investigational Medicinal Product
IMPD Investigational Medicinal Product Dossier
Investigator Clinician or nurse involved in a clinical trial
IRB* Institutional Review Board / Independent Review Board
ISF Investigator Site File
ISRCTN International Standard Randomised Controlled Trial Number
LOA Letter of Access
MA Marketing Authorisation
MAH Marketing Authorisation Holder
MedDRA Medical Dictionary for Regulatory Activities (global standard medical terminology used in the medical product development process)
MHRA Medicines and Healthcare products Regulatory Agency
MRC Medical Research Council
MREC Multi-centre Research Ethics Committee
MS Member State
MTD Maximum Tolerated Dose
NDA* Non-Disclosure Agreement
NDA* New Drug Application (FDA)
NHS R&D National Health Service Research & Development
NHS REC National Health Service Research Ethics Committee
NICE National Institute for Health and Clinical Excellence
NRES National Research Ethics Service (formerly COREC – Central Office for Research Ethics Committees)
OTC Over-the-Counter (refers to non-prescription drugs)
Participant Person participating in a clinical trial
PD Pharmacodynamics
Phase I

Phase I or Healthy Volunteer Studies are non-placebo controlled, small studies, and the first test of a drug in humans.

  • To establish safe/tolerable levels
  • To establish initial pharmacology in humans
  • Usually carried out on volunteers who may be paid
Phase II

Phase II studies are non-placebo controlled or randomised studies.

  • To provide evidence of activity and better evidence of safety
  • To define dosage and regimen
  • Includes participants with the disease
Phase III

Phase III studies are usually larger scale comparative, controlled trials

  • To assess the risks and benefits
  • To compare benefits/side effects with those of other drugs or a placebo
  • Includes participants with the disease
PI Principal Investigator at a trial site
PIL Patient Information Leaflet
PIS Patient Information Sheets
PK Pharmacokinetics
PMA Pre-Market Approval Application (FDA)
QA Quality Assurance
QC Quality Control
QP Qualified Person responsible for final despatch of trial drug
R&D Research & Development
RCT Randomised Controlled Trial
RDE Remote Data Entry
REC Research Ethics Committee
RFP Request for Proposal
RN Research Nurse
SAE Serious Adverse Event
SAR Serious Adverse Reaction
SD Standard deviation
SDV Source document/data verification
SIG Special Interest Group
SIV Site Initiation Visit
SMO Site Management Organisation
SmPC Summary of Product Characteristics
SOPs Standard Operating Procedures
SPC Summary of Product Characteristics
Sponsor Individual/organisation responsible for the initiation, management/financing of a clinical trial
SSA Site Specific Assessment
SSC Study Site Co-ordinator
SSI Site-Specific Information
SUE Serious Unexpected Event
SUSAR Suspected Unexpected Serious Adverse Reaction
TMF Trial Master File
TMG Trial Management Group
TSC Trial Steering Committee

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