R&D Glossary of Terms
Glossary of Acronyms Commonly used in Research and Development
ABPI - Association of the British Pharmaceutical Industry
ADME - Absorption, Distribution, Metabolism and Excretion
ADR - Alternative Dispute Resolution Notice
AE - Adverse Event
AHPs - Allied Healthcare Professionals
AMS -Academy of Medical Sciences
APTUK - Association of Pharmacy Technicians UK
ARCP - Association of Clinical Research Professionals
ARSAC - Administration of Radioactive Substances Advisory Committee
ASR - Annual Safety Report
BARQA - The Research Quality Association
BOPA - British Oncology Pharmacy Association
C&V - Cardiff and Vale UHB
CA - Competent Authority
CAPA - Corrective and Preventative Action Plan
CAS - Central Allocation System (Research Ethics Committee)
CCRN - Comprehensive Clinical Research Network (England)
CE - Chief Executive
CI - Chief Investigator
CIOMS - Council for International Organizations of Medical Sciences (CIOMS-1 is an internationally recognised safety report form)
LCRN - Local Clinical Research Network (England)
CNST - Clinical Negligence Scheme for Trusts (England)
CLRN - Comprehensive Local Research Network (England)
CO MA - Conditions of Management Approval Agreement
COPE - Committee on Publications Ethics
CPPE - Centre of Pharmacy Postgraduate Education
CRA - Clinical Research Associate
CRF - Case Report Form or Clinical Research Facility
CRN - Clinical Research Network
CRO - Contract Research Organisation
NIHR CSP - Coordinated System for gaining NHS Permission unit (England)
CSR - Clinical Study Report (Final Report)
CT - Clinical Trial
CT Regulations - The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent Amendments
CTA - Clinical Trial Authorisation
CTA - Clinical Trial Agreement
CTC - Clinical Trial Certificate
CTIMP - Clinical Trial of an Investigational Medicinal Product
CTR - Centre for Trials Research (Cardiff University)
CTX - Clinical Trial Exemption
CU - Cardiff University
CV - Curriculum Vitae
DDX - Doctors’ & Dentists’ Exemption
DHSC - Department of Health and Social Care
DMC - Data Monitoring Committee
DMEC - Data Monitoring and Ethics Committee
DMP - Data Monitoring Plan
DPA - Data Protection Act 1998
DPO - Data Protection Officer
DSUR - Development Safety Update Report
EC - European Commission
ECRIN - European Clinical Research Infrastructure Network
EEA - European Economic Area
EMA - European Medicines Agency
ETC - Excess Treatment Cost
EU - European Union
EU CTD - EU Clinical Trials Directive (2001/20/EC)
EU GCP - EU Good Clinical Practice Directive (2005/28/EC)
EudraCT - European database of Clinical Trials
EudraVigilance - European database of safety incidents in clinical trials
FD - Financial Director
FDA - Food and Drugs Administration (USA)
GAfREC - Governance Arrangements for Research Ethics Committees
GCLP - Good Clinical Laboratory Practice
GCP - Good Clinical Practice
GDP - Good Dispensary Practice
GLP - Good Laboratory Practice
GMP - Good Manufacturing Practice
GP - General Practitioner
GTAC - Gene Therapy Advisory Committee
HCRW - Health and Care Research Wales
Host QA Visit - Host Quality Assurance Visit (for CTIMPs hosted by C&V UHB)
HRA - Health Research Authority
HRA RES - HRA Research Ethics Service
HRC - Honorary Research Contract
HSEU - Health, Safety and Environment Unit (C&V UHB)
HT - Human Tissue
HTA - Human Tissue Authority
IB - Investigator Brochure
ICF - Informed Consent Form
ICH - International Committee / Conference for Harmonisation
ICR - Institute of Clinical Research
ID - Identification
IEC - Independent Ethics Committee
IM&T - Information Management and Technology
IMP - Investigational Medicinal Product
IP - Intellectual Property
IPR - Intellectual Property Rights
IRAS - Integrated Research Application System
IRB - Institutional Review Board
IRF - Incident Record Form
IRG - Interdisciplinary Research Group
IRMER - Ionising Radiation (Medical Exposure) Regulations
ISRCTN - International Standard Randomised Controlled Trial Number
IT - Information Technology
JPMA - Japan Pharmaceutical Manufacturers Association
LC - Local Collaborator
LHB - Local Health Board (Wales)
LOA - Letter of Access
LREC - Local Research Ethics Committee
MA (+MA IMP) - Marketing Authorisation (of an IMP)
MCA - Mental Capacity Act 2005
mCTA - Model Clinical Trial Agreement
MHRA - Medicines and Healthcare Products Regulatory Authority
MIA - Master Indemnity Agreement
mICRA - Model Industry Collaborative Research Agreement
MMAU - Medicines Management Academic Unit
mNCA - model Non Commercial Agreement
MRC - Medical Research Council
MREC - Multi-centre Research Ethics Committee
MTA - Material Transfer Agreement
NHS - National Health Service
NHS PEDC - Pharmacy Education and Development Committee
NHS SC - NHS Support Costs
NHS TSET - Pharmaceutical Technical Specialists Education and Training Committee
NICE - National Institute for Health and Clinical Excellence
NIGB - National Information Governance Board
NIHR - National Institute for Health Research
NMC - Nursing and Midwifery Council
NOMS - National Offender Management Service (Ministry of Justice)
NPSA - National Patient Safety Agency
OD&T - Organisational Development & Training
OID - Organisational Information Document (often used as a site agreement)
PC - Protocol Checklist
Ph I/II/III/IV - Phase I/II/III/IV clinical trial
PhRMA - Pharmaceutical Research and Manufacturers of America
PI - Principal Investigator
PIAG - Patient Information Advisory Group
PIC - Participant Identification Centre
PICTF - Pharmaceutical Industry Competitive Task Force
PID - Patient Identifiable Data
PIE - Public Involvement and engagement
PIS - Participant Information Sheet
PoC - Point of Contact
POWs - Prisoners of War
PPI - Patient and Public Involvement
Project ID No - Project Identification Number
PSUR - Periodic Safety Update Report
PTQA - Pharmaceutical Technology and Quality Assurance
PV - PharmacoVigilance
QA - Quality Assurance
QC - Quality Control
QP - Qualified Person
R&D - Research and Development
R&E - Research and Effectiveness
RACD - Research and Commercial Division (Cardiff University)
RAF - Risk Assessment Form
RCA -Root Cause Analysis
RCT - Randomised Control Trial
REC - Research Ethics Committee
RES form - Laboratory Tests Research Form
RG - Research Governance
RGC - Research Governance Coordinator
RGF - Research Governance Framework for Health and Social Care
RGG - Research Governance Group (C&V UHB)
RM&G - Research Management & Governance
RMT - Risk Management Team
RPS - Royal Pharmaceutical Society
RS&G - Research Support & Governance
RS&PD - Researcher Support & Portfolio Development
RTB - Research Tissue Bank
SADR - Serious Adverse Drug Reaction
SAE - Serious Adverse Event
SAM - Sponsor Assessment Meeting
SAP - Statistical Analysis Plan
SB - Serious Breach (of GCP or protocol)
SDL - Study Delegation Log
SDV - Source Data Verification
SI - Statutory Instrument
SI Units - International Systems of Units
SLA - Service Level Agreement
SmPC - Summary of Product Characteristics
SMPU - St Mary’s Pharmaceutical Unit (C&V UHB)
SoM - School of Medicine – College of Biomedical & Life Sciences
SOP - Standard Operating Procedure
SPARC - Streamlined NHS Permissions Approach to Research – Cymru (now NISCHR PCU)
SpR - Specialist Registrar
SPS - Sterile Product Services (C&V UHB)
SSA - Site-Specific Assessment
SSAR - Suspected Serious Adverse Reaction
SSI - Site Specific Information Form (historical)
SUSAR - Suspected Unexpected Serious Adverse Reaction
TMF - Trial Master File
ToR - Terms of Reference
TSC - Trial Steering Committee
TSF - Trial Site File
UHB - University Health Board
UHL - University Hospital Llandough
UHW - University Hospital of Wales, Cardiff
UKCRN - UK Clinical Research Network
USM(s) - Urgent Safety Measure(s)
WG - Welsh Government
WHC - Welsh Health Circular
WMA - World Medical Association
WRP - Welsh Risk Pool
