AE Adverse Event
AMRC Association of Medical Research Charities
AR Adverse Reaction
BMJ British Medical Journal
CA Competent Authority
CF Consent Form
CI Chief Investigator

There is some ambiguity in the Regulations as to the definition of a CI, MHRA have clarified the following: Chief Investigator means:
(a) in relation to a clinical trial conducted at a single trial site, the investigator for that site
(b) in relation to a clinical trial conducted at more than one trial site, the authorised health care professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the trial; That is:
(a) a doctor,
(b) a dentist,
(c) a nurse,
(d) a pharmacist

Collaborative Group A group of clinicians collaborating in a clinical trial
Collaborator Clinician collaborating in a clinical trial
COREC Central Office of Research Ethics Committees
CPMP Committee for Proprietary Medicinal Products
CRF Clinical Record Form/Case Report Form
CRO Clinical Research Organisation
CTA Clinical Trial Authorisation
CTA* Clinical Trial Agreement
CTC Clinical Trial Certificate
CTD Clinical Trial Directive
CTD* Common Technical Document
CTX Clinical Trials Exemption Certificate
CV Curriculum Vitae
DDX Doctors and Dentists Exemption Certificate
DMC Data Monitoring Committee
DMEC Data Monitoring and Ethics Committee
EC European Commission
EMEA European Agency for the Evaluation of Medicinal Products
EU European Union
EU CTD European Union Clinical Trial Directive
EudraCT European Clinical Trial Database
EudraVIGILANCE European Database for Pharmacovigilance
GCP Good Clinical Practice
GMP Good Manufacturing Practice
IB Investigator’s Brochure
ICH International Conference on Harmonisation
IMP Investigational Medicinal Product
IMPD Investigational Medicinal Product Dossier
ISRCTN International Standard Randomised Controlled Trial Number
MA Marketing Authorisation
MAH Marketing Authorisation Holder
MHRA Medicines and Healthcare products Regulatory Agency
MRC Medical Research Council
MREC Multi-centre Research Ethics Committee
MS Member State
NHS R&D National Health Service Research & Development
NHS REC National Health Service Research Ethics Committee
Participant Person participating in a clinical trial
PI Principal Investigator at a trial site
PIS Patient Information Sheets
Phase I Phase I or Healthy Volunteer Studies are non-placebo controlled, small studies, and the first test of a drug in humans.

• To establish safe/tolerable levels
• To establish initial pharmacology in humans
• Usually carried out on volunteers who may be paid

Phase II Phase II studies are non-placebo controlled or randomised studies.

• To provide evidence of activity and better evidence of safety
• To define dosage and regimen
• Includes participants with the disease

Phase III Phase III studies are usually larger scale comparative, controlled trials.

• To assess the risks and benefits
• To compare benefits/side effects with those of other drugs or a placebo
• Includes participants with the disease

QA Quality Assurance
QC Quality Control
QP Qualified Person responsible for final despatch of trial drug
R&D Research & Development
RCT Randomised Controlled Trial

Most clinical trials should be designed so that the results are applicable to clinical practice in the general population, e.g. Pragmatic
Pragmatic
• Assesses risks and benefits
• Addresses practical questions, under ‘real life’ conditions
• Should X or Y be recommended overall?
• Broader range of issues including cost, side effects, compliance

REC Research Ethics Committee
SAR Serious Adverse Reaction
SAE Serious Adverse Event
SD Standard deviation
SDV Source document/data verification
SmPC Summary of Product Characteristics
SOPs Standard Operating Procedures
Sponsor Individual/organisation responsible for the initiation, management/financing of a clinical trial
SSA Site Specific Assessment
SUE Serious Unexpected Event
SUSAR Suspected Unexpected Serious Adverse Reaction
TMG Trial Management Group
TSC Trial Steering Committee