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Glossary

ADR Adverse Drug Reaction
AE Adverse Event
AR Adverse Reaction
CA Competent Authority
CANIS Cancer Network Information System 
CAS Central Allocation System
CI Chief Investigator
CLAHRC Collaborations for Leadership in Applied Health Research and Care
CLRN Comprehensive Local Research Network
CRA Cricial Research Associate
CRF Clinical Record Form
CRO Clinical/Contract Research Organisation
CSO Clinical Studies Officer
CSP Central Sign-off Process
CTA Clinical Trial Administrator
CTA Clinical Trial Authorisation
CTIMP Clinical Trial of an Investigational Medicinal Product
CTU Clinical Trials Unit
DCT Data Collection Tool
EDC Electronic Data Capture
EMA European Medicine Agency
EU CTD European Union Clinical Trial Directive
EudraCT European Union Drug Regulating Authorities Clinical Trials (Database)
EudraVIGILANCE European Database for Pharmacovigilance
FDA Food and Drug Administration
GAfREC Governance Arrangements for NHS Research Ethics Committees
GCP Good Clinical Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
HEI Higher Education Institute
HTA Human Tissue Act
IB Investigaor brochure
ICH International Conference on Harmonisation
ICR Institute of Clinical Research
IEC Independent Ethics Committee
IMP Investigational Medicinal Product
IMPD Investigational Medicinal Product Dossier
IRAS Integrated Research Application System 
ISRCTN International Standard Randomised Controlled Trial Number
ISS Infrastructure Support Services
ITAP Industry Trials Adoption Process
KSF Knowledge and Skills Framework
LMS Learning Management System
MA Marketing Authorisation
MHRA Medicinal and Healthcare Products Regulatory Agency
MDTs Multi Disciplinary Teams
MS Member State
MoU Memorandum of Understanding
NRES National Research Ethics Service
NREA National Research Ethics Adviser
OMG Operational Management Group
OSG Operational Steering Group
PI Principal Investigator
PLA Product Licence Application
PPI Patient and Public Involvement
QA Quality Assurance
QC Quality Control
QP Qualified Person responsible for final despatch of trial drug
R&D Research and Development
RCT Randomised Controlled Trial
RDG Research Development Group
REC Research Ethics Committee
RED Research Ethics Database
RGF Research Governance Framework
RM&G Research Management and Governance
RNMs Research Network Managers
RO Research Officer
RRN Regional Research Network
RRGs Registered Research Groups
SAE Serious Adverse Event
SAR Serious Adverse Reaction
SDV Source Document Verification
SHA Strategic Health Authority
SOPs Standard Operating Procedures
SmPC Summary of Product Characteristics
SSA Site Specific Assessment
SSC Study Site Coordinator
SSCs Service Support Costs
SUAG Service User Advisory Group
SUSAR Suspected Unexpected Serious Adverse Reaction
TCRNs Topic Comprehensive Research Networks
TMF Trial Master File
TMG Trial Management Group
TSC Trial Steering Committee
TSG Trial Steering Group
TU Trials Unit
WHO World Health Organisation