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
