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
 CAS  Central Allocation Service
 CI  Chief Investigator
 COREC  Central Office for Research Ethics Committees
 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 Practical
 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
 SHA  Strategic Health Authority
 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