The ICR – The Institute of Clinical Research

GCP – Good Clinical Practice

GMP – Good Manufacturing Practice

GLP – Good Laboratory Practice

SOP – Standard Operating Procedure – detailed instructions to achieve uniformity of the performance of a specific function

Investigator: Responsible for the conduct of a clinical trial at a clinical site e.g. hospital, clinic, clinical trial unit

Subject/Trial Participant: An individual who participates in a clinical trial either as a recipient of the Investigational Medicinal Product or a control

Sponsor: An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.

Protocol: A document that describes the objective/s, design, methodology, statistical considerations and organisation of the trial.

Investigational Medicinal Product (IMP): A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.

RA – Regulatory Authority

CA – Competent Authority (EU Term)

MHRA – The Medicines and Healthcare products

Regulatory Agency (UK)

FDA – The Food and Drug Administration

EMA – European Medicines Agency

NICE – National Institute of Clinical Excellence

HRA – Health Research Authority (England)

NIHR – National Institute of Health

EC/IRB – Ethics Committee/Institutional Review Board

DSMB/DMC – Data Safety Monitoring Board/Data Monitoring Committee