Glossary

A

AE - Adverse Event

AR - Adverse Reaction

ASR - Annual Safety Report

B

BRC - Biomedical Research Centre

C

CA - Competent Authority

CI - Chief Investigator

CRF - Case Report Form

CRO - Contract Research Organisation

D

DPA - Data Protection Act (2018)

DMC - Data Monitoring Committee EC European Commission

G

GAfREC - Governance Arrangements for NHS Research Ethics Committees

GDPR - General Data Protection Regulation (2018)

I

ICF - Informed Consent Form

ISRCTN - International Standard Randomised Controlled Trial Number

M

MA - Marketing Authorisation

MS - Member State

Main REC - Main Research Ethics Committee

N

NHS R&D - National Health Service Research & Development

P

PI - Principle Investigator

Q

QA - Quality Assurance

QC - Quality Control

R

RCT - Randomised Controlled Trial

REC - Research Ethics Committee

S

SAE - Serious Adverse Event

SDV - Source Document Verification

SOP - Standard Operating Procedure

SSA - Site Specific Assessment

T

TMG - Trial Management Group

TSC - Trial Steering Committee