Abbreviations

 AE Adverse Event
 ADR Adverse Drug Reaction
 CA Competent Authority
 CI Chief Investigator
 CPMP Committee for Proprietary Medicinal Products (known as CHMP - Committee for Medicinal Product for Human Use)
 CRC Clinical Research Centre
 CRF Case Report Form
 CTA Clinical Trial Authorisation
 CTIMP Clinical Trial of an Investigational Product
 EC European Commission
 EMEA European Medicines Agency
 EU European Union
 EudraCT European Clinical Trials Database (European Union Drug Regulating Authorities Clinical Trials)
 GCP Good Clinical Practice
 GLP Good Laboratory Practice
 GMP Good Manufacturing Practice
 GTAC Gene Therapy Advisory Committee
 IB Investigators Brochure
 ICH International Conference on Harmonisation
 IMP Investigational Medicinal Product
 IRAS Integrated Research Application System
 MA Marketing Authorisation 
 MHRA Medicines and Healthcare Products Regulatory Authority
 NRES National Ethics Research Service 
 PI Principal Investigator
 PIAG Patient Information Advisory Group
 PIS Patient/participant Information Sheet 
 R&D Research and Development
 REC Research Ethics Committee 
 SAE Serious Adverse Event
 SAR  Serious Adverse Reaction 
 SI Statutory Instrument
 SmPC Summary of Product Characteristics
 SOP Standard Operating Procedure 
 SSA Site Specific Assessment
 SSIF Site Specific Information Form
 SUSAR Suspected Unexpected Serious Adverse Reaction
 TMF Trial Master File
 TCTU Tayside Clinical Trials Unit
 UK United Kingdom