CTRG glossary

A B C D E G H I M N O P S T

A

AE: adverse event

AR: adverse reaction

ARSAC: Administration of Radioactive Substances Advisory Committee

B

BRC: Biomedical Research Centre

C

CA: competent authority

CE: Conformité Européenne

CI: chief investigator

CRA: clinical research associate (monitor)

CRF: case report form

CRO: contract research organisation

CSP: co-ordinated system for NHS permissions

CT: clinical trials

CTA: clinical trials authorisation

CTIMP: clinical trial of an investigational medicinal product

CTRG: Clinical Trials and Research Governance

CUREC: Central University Research Ethics Committee

CV: curriculum vitae

D

DMC/DMSC: data monitoring committee/data monitoring and safety committee

DoH: Department of Health

DPA: Data Protection Act

DSUR: development safety update report

E

EUCTD: European Union Clinical Trials Directive 

EudraCT: European Union Drug Regulating Authorities Clinical Trials

G

GCP: good clinical practice

GLP: good laboratory practice

GMP: good manufacturing practice

GP: general practitioner

H

HRA: Health Research Authority

HTA: Human Tissue Act or Human Tissue Authority

I

IB: investigators brochure

ICF: informed consent form

ICH: International Conference of Harmonisation

ICMJE: International Committee of Medical Journal Editors

IEC: independent ethics committee

IMP: investigational medicinal product

IRAS: Integrated Research Application System

IRB: independent review board

ISF: investigator site file

ISRCTN: International Standard Randomised Controlled Trial Number Register

M

MCA: Mental Capacity Act

MHRA: Medicines and Healthcare Products Regulatory Agency

N

NHS: National Health Service

NIHR: National Institute for Health Research

NRES: National Research Ethics Service

O

OUHT: Oxford University Hospitals NHS Trust

OxTREC: Oxford Tropical Research Ethics Committee

P

PI: principal investigator

PIL: participant/patient information leaflet

PIS: participant/patient information sheet

R&D: NHS Trust R&D Department

REC: research ethics committee

RGF: Research Governance Framework

S

SAE: serious adverse event

SAR: serious adverse reaction

SDV: source data verification

SmPC: summary of medicinal product characteristics

SOP: standard operating procedure

SSI: site specific information

SUSAR: suspected unexpected serious adverse reactions

T

TMF: trial master file

TSG: Oxford University Hospitals Trust/University of Oxford Trials Safety Group

TVCLRN: Thames Valley Comprehensive Local Research Network