Abbreviations

ABPI

Association of the British Pharmaceutical Industry

ADR

Adverse Drug Reaction

AE

Adverse Event

AR

Adverse Reaction

ARSAC

Administration of Radioactive Substances Advisory Committee

CI

Chief Investigator

CRA

Clinical Research Associate

CRF

Case Report Form

CRO

Clinical Research Organisation

CTA

Clinical Trial Authorisation

DMC

Data Monitoring Committee

DOH

Department Of Health

DSMB

Data Safety Monitoring Board

EU

European Union

EUDRACT

European Clinical Trials Database

GCP

Good Clinical Practice

GTAC

Gene Therapy Advisory Committee

IB

Investigator Brochure

ICF

Informed Consent Form

ICH

International Conference on Harmonisation

IMP

Investigational Medicinal Product

IRAS

Integrated Research Approval System

IRMER

Ionising Radiation (Medical Exposure Regulations)

NRES

National Research Ethics Committee

MHRA

Medicines and Healthcare products Regulatory Agency

PI

Principal Investigator

QA

Quality Assurance

R&D

Research & Development

REC

Research Ethics Committee

SAE

Serious Adverse Event

SOP

Standard Operating Procedures

SSAR

Suspected Serious Adverse Drug Reaction

SUSAR

Suspected Unexpected Serious Adverse Reaction