Glossary

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Click on the term to see the definition and weblink (where applicable)

 Acronym
(where applicable)

Term

AE

Adverse Event

AR

Adverse Reaction

CERB

College Ethics Review Board

CHaRT

Centre for Healthcare Randomised Trials

CI

Chief Investigator

CLSM

College of Life Sciences and Medicine

CRF

Case Report Form

CRN

Clinical Research Network

CSO

Chief Scientist Office

CSOG

Clinical Studies Oversight Group

CTA*

Clinical Trial Authorisation

CTA*

Clinical Trial Agreement

CTIMP

Clinical Trial of an Investigational Medicinal Product

CTU

Clinical Trials Unit

DAHS

Division of Applied Health Sciences

DC

Data Coordinator

DMC

Data Monitoring Committee

DMP

Data Management Plan

 

Data protection

 

Declaration of Helsinki

DOC

Delivery of Care

DSUR

Development Safety Update Report

EMA

European Medicines Agency

EudraCT

European Clinical Trial Database

EudraVIGILANCE

European Database for Pharmacovigilance

EUCTD

EU clinical trials directives

GCP

Good Clinical Practice

GET-IT

Glossary of Evaluation Terms for Informed Treatment choices

HCA

Health Care Assessment

HRA

Health Research Authority

HSC R&D

Health and Social Care Gateway R&D Division (Northern Ireland)

HSCIC

Health and Social Care Information Centre

HSRU

Health Services Research Unit

IAHS

Institute of Applied Health Sciences

IB

Investigator's Brochure

ICH

International Council on Harmonisation

ICMJE

International Committee of Medical Journal Editors

IMPD

Investigational Medicinal Product Dossier

ISRCTN

International Standard Randomised Controlled Trial Number

IRAS

Integrated Research Application System

ISF

Investigator Site File

IVRS

Interactive Voice Response System

LRM

Lunchtime Research Meeting

MCN

Managed Clinical Network

MHRA

Medicines and Healthcare products Regulatory Agency

 

Medicines for Human Use (Clinical Trials) Regulations 2004

MRC

Medical Research Council

MAGI

Monitoring And Audit Group

MNCA

Model agreement for Non-Clinical research Agreement

NES

NHS Education for Scotland

NETSCC

NIHR Evaluation, Trial and Studies Co-ordinating Centre

NICE

National Institute for Health and Care Excellence

NIHR CRNCC

National Institute for Health Research Clinical Research Network Coordinating Centre

NIHR HTA

National Institute for Health Research Health Technology Assessment programme

NIHR RfPB

National Institute for Health Research: Research for Patient Benefit

NISCHR

National Institute for Social Care and Health Research
(Welsh Co-ordinating function)

NOCRI

NIHR Office for Clinical Research Infrastructure

NOSRES

North of Scotland Research Ethics Service

NRES

National Research Ethics Service

NRS Permissions CC

NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) in Scotland

PI

Principal Investigator

PIL

Patient or Participant Information Leaflet

PMG

Project Management Group

PPI

Patient and Public Involvement

QA

Quality Assurance

QALY

Quality Adjusted Life Years

QC

Quality Control

QP

Qualified Person

RCT

Randomised Controlled Trial

R&D

Research & Development

REC

Research Ethics Committee

 

Research governance

RGF

Research governance framework

 

Research passport

RN

Research Nurse

SAE

Serious Adverse Event

SAP

Statistical Analysis Plan

SAR

Serious Adverse Reaction

SB

Serious breach

SDV

Source document/data verification

SIGN

Scottish Intercollegiate Guidelines Network

SMC

Scottish Medicines Consortium

SmPC

Summary of Product Characteristics

SoA

Statement of Activities

SoE

Schedule of Events

SOP

Standard Operating Procedure

SPIRIT

Standard Protocol Items: Recommendations for Interventional Trials

SSA

Site Specific Assessment

SSI

Site Specific Information

SUSAR

Suspected Unexpected Serious Adverse Reaction

SWAR

Studies Within A Review

SWAT

Studies Within A Trial

TM

Trial Manager

TMF

Trial Master File

TSC

Trial Steering Committee

UKTMN

UK Trial Managers' Network

USM

Unit Staff Meeting

WPD

Working Practice Document

 

* This abbreviation has more than one meaning

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