Glossary

Glossary

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

Acronym
(where applicable)
Term
AE Adverse Event
AR Adverse Reaction
CATEF Conference and Training Evaluation Form
CATRF Conference and Training Request Form
CE European Conformity
CHaRT Centre for Healthcare Randomised Trials
CI* Chief Investigator
CI* Confidence Interval
CLSM College of Life Sciences and Medicine
CONSORT Consolidated Standards of Reporting Trials
COS Core Outcome Set
CPMS Central Portfolio Management System
CRF Case Report Form
CRN Clinical Research Network
CSO Chief Scientist Office
CSOG Clinical Studies Oversight Group
CT Clinical Trial
CTA* Clinical Trial Authorisation
CTA* Clinical Trial Agreement
CTIMP Clinical Trial of an Investigational Medicinal Product
CTU Clinical Trials Unit
DC Data Coordinator
DCE Discrete Choice Experiment
DMC Data Monitoring Committee
DMP Data Management Plan
DP Data Protection
DSUR Development Safety Update Report
EDI Equality, Diversity and Inclusion
eDRIS electronic Data Research and Innovation Service
EMA European Medicines Agency
ePRO electronic Patient Reported Outcomes
EUCTD EU clinical trials directives
FOI Freedom of Information
GCP Good Clinical Practice
GDPR General Data Protection Regulation
GET-IT Glossary of Evaluation Terms for Informed Treatment choices
GLM General Linear Model
GRP Good Research Practice
HCA Health Care Assessment
HEAP Health Economic Analysis Plan
HERU Health Economics Research Unit
HES Hospital Episode Statistics
HIS Healthcare Improvement Scotland
HRA Health Research Authority
HSC R&D Health and Social Care Gateway R&D Division (Northern Ireland)
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/sIMPD Investigational Medicinal Product Dossier
ImpEC Improving Experiences of Care
IRAS Integrated Research Application System
ISD Information Services Division
ISF Investigator Site File
ISRCTN International Standard Randomised Controlled Trial Number
IVR Interactive Voice Response
LIP Local Information Pack
LOA Letter of Access
LRM Lunchtime Research Meeting
Medicines for Human Use (Clinical Trials) Regulations 2004
MCN Managed Clinical Network
MHRA Medicines and Healthcare products Regulatory Agency
MNCA Model Non-Commercial Agreement
MRC Medical Research Council
NHS England
NES NHS Education for Scotland
NETSCC NIHR Evaluation, Trial and Studies Co-ordinating Centre
NHSD NHS Digital (now NHS England)
NICE National Institute for Health and Care Excellence
NIHR CRNCC National Institute for Health and Care Research: Clinical Research Network Coordinating Centre
NIHR EME National Institute for Health and Care Research: Efficacy and Mechanism Evaluation
NIHR HS&DR National Institute for Health and Care Research: Health Services and Delivery Research
NIHR HTA National Institute for Health and Care Research: Health Technology Assessment programme
NIHR PGfAR National Institute for Health and Care Research: Programme Grants for Applied Research
NIHR RfPB National Institute for Health and Care 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
NRS NHS Research Scotland
NRS Permissions CC NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) in Scotland
OID Organisation Information Document
ONS Office for National Statistics
PEG Public Engagement Group
PI Principal Investigator
PIC Participant Identification Centre
PIL Patient or Participant Information Leaflet
PMG Project Management Group
PPI Patient and Public Involvement
PPIE Patient and Public Involvement and Engagement
PRO/ePRO Patient Reported Outcome/electronic Patient Reported Outcome
PROM Patient Reported Outcome Measures
PWI Project Website Initiation
QA Quality Assurance
QALY Quality Adjusted Life Years
QC Quality Control
Research governance
R&D Research & Development
R&I Research and Innovation
RCT Randomised Controlled Trial
REC Research Ethics Committee
RES Research Ethics Service
RGF Research governance framework
RP Research passport
RN Research Nurse
Sponsor
SADE Serious Adverse Device Effect
SAE Serious Adverse Event
SAP Statistical Analysis Plan
SAR Serious Adverse Reaction
SB Serious breach
SD Standard Deviation
SDV Source document/data verification
SERB School Ethics Review Board
SIGN Scottish Intercollegiate Guidelines Network
SIV Site Initiation Visit
SMC Scottish Medicines Consortium
SMMSN School of Medicine, Medical Sciences and Nutrition
SmPC or SPC Summary of Product Characteristics
SoA Statement of Activities
SoE Schedule of Events
SoECAT Schedule of Events Cost Attribution Tool
SOP Standard Operating Procedure
SPIRIT Standard Protocol Items: Recommendations for Interventional Trials
STA Single Technology Appraisal
SUSAR Suspected Unexpected Serious Adverse Reaction
SWAR Studies Within A Review
SWAT Studies Within A Trial
TAR Technology Assessment Review
THIS Institute The Healthcare Improvement Studies Institute
TM Trial Manager
TMF Trial Master File
TSC Trial Steering Committee
TSD Trial Service Definition
UAT User Acceptance Testing
UKTMN UK Trial Managers' Network
USADE Unanticipated Serious Adverse Device Effect
USM* Unit Staff Meeting
USM* Urgent Safety Measure
WPD Working Practice Document
WTP Willingness To Pay
* This abbreviation has more than one meaning