Clinical Research Glossary
All the Acronyms that are Good to Know!
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.
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Phase II |
Phase II studies are non-placebo controlled or randomised studies.
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Phase III |
Phase III studies are usually larger scale comparative, controlled trials
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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 |