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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

Health and Care Research Wales Logo.


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