Acronyms

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

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

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

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