A quick reference guide for acronyms commonly used in relation to research governance and health and social care research

Acronyms A-G

A
 ABPI  Association of  British Pharmaceutical Industry
 AE  Adverse Event
 AR  Adverse Reaction
 ARSAC  Association of Radioactive Substances Advisory Committee
B
BMA  British Medical Association
C
 CA  Competent Authority
 CAG  Confidentiality Advisory Group
 CI  Chief Investigator
 CRF  Case Report Form
 CRO  Contract Research Organisation
 CSR Clinical Study Report
 CTA  Clinical Trial Authorisation
 CTA*  Clinical Trial Agreement
 CTD  Clinical Trials Directive
E
 EMA  European Medicines Agency
F
FDA  Food and Drug Administration
G
 GCP  Good Clinical Practice
 GMC  General Medical Council
 GMP  Good Manufacturing Practice

Acronyms I-R

I
 ICH  International Conference on Harmonisation
 IMP  Investigational Medicinal Product
 ISRCTN  International Standards Randomised Control Trial Number
L
 LREC  Local Research  Ethics Committee
M
 MA  Manufacturing Authorisation
 MHRA  Medicines and Healthcare practices Regulatory Agency
 MRC  Medical Research Council
 MREC  Multicentre Research Ethics  Committee
P
PI  Principle Investigator
Q
 QA  Quality Assurance
 QC  Quality  Control
 QP  Qualified Person
R
 R&D  Research and Development
 REC  Research Ethics Committee

Acronyms S-W

S
 SAE  Serious Adverse Events
 SAR  Serious Adverse Reaction
 SOP  Standard Operating Procedure
 SSA  Site Specific Assessment
 SUSAR  Suspected Unexpected Serious Adverse Reaction
T
 TMF  Trial Master File
 TSC  Trial Steering Committee
U
UKCRC  United Kingdom Clinical Research Collaboration
UKECA  United Kingdom Ethics Committee Authority
W
 WMA  World Medical Association