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Acronyms, Abbreviations & Definitions for Clinical Research
AcoRD - Attributing the costs of health and social care Research and Development
AE - Adverse Event
Amendment - A written description of a change or formal clarification.
AR - Adverse Reaction
ARSAC - Administration of Radioactive Substances Advisory Committee:
ATMP - Advanced Therapy Medicinal Products
CAG - Confidentiality Advisory Group
CC - Coordinating Centre
CCG - Clinical Commissioning Group
CF - Consent Form (also ICF)
CI - Chief Investigator
COPD - Chronic Obstructive Pulmonary Disease
CPMS - Central Portfolio Management System
CPRD - Clinical Practice Research Datalink
CQC - Care Quality Commission
CRF - Case Report Form
CRN - Clinical Research Network
CRO - Clinical Research Organisation or Contract Research Organisation
CT - Clinical Trial
CTA - Clinical Trials Agreement
CTIMP - Clinical Trial of an Investigational Medicinal Product
CTU - Clinical Trials Unit
DoH - Department of Health
DNA - Did Not Attend
EOI - Expression of interest
GCP - Good Clinical Practice
HaST - Hartlepool and Stockton
HPCA - Hadrian Primary Care Alliance
HTA - Human Tissue Act / Authority
IB - Investigator Brochure
ICF - Informed Consent Form
IMP - Investigational Medicinal Product
Indemnity - Compensation for damage, loss or injury
Investigator - Researcher conducting the (clinical) study, those researchers leading the team, referred to as CI or PI
IRAS - Integrated Research Application System
IRMER - Ionising Radiation Medical Exposure Regulations
ISF - Investigator Site File
ISRCTN - International Standard Randomised Control Trial Number
LOA - Letter of Access
MDT - Multi-Disciplinary Team
MHRA - Medicines and Healthcare products Regulatory Agency
MRI - Magnetic Resonance Imaging
mNCA - Model Non-Commercial Agreement for clinical research studies
Monitor - The person designated by the sponsor to perform site visits and conduct the monitoring of the research studies process.
MTA - Material Transfer Agreement
Multi-centre Study - Study conducted according to a single protocol but carried out at more than one site and by more than one investigator; one CI oversees several PIs
NCIC - North Cumbria Integrated Care
NECS - North of England Commissioning Support
NIHR - National Institute for Health Research
Non Substantial Amendments - Changes to the details of a study that have no significant implications for the subjects, the conduct, the management or the scientific value of the study (sometimes referred to as administrative amendments).
Participant - An individual taking part in research ‘patients’ become ‘participants’ on being recruited to a study
PC - Primary Care
PI - Principal Investigator
PIC - Participant Identification Centre
PIS/PIL - Patient Information Sheet / Leaflet
PO - Partner Organisation
PPIE - Patient and Public Involvement and Engagement
PRES - Patient Research Experience Survey
QI - Quality Improvement
QOF - Quality Outcome Framework
QOL - Quality of Life
R & D (I) - Research and Development (Innovation)
RCGP - Royal College of General Practitioners
RCT - Randomised Controlled Trial
RDM - Research Delivery Manager
RDN - Research Delivery Network
REC - Research Ethics Committee
ROC - Research Operations Coordinator
ROO - Research Operations Officer
RRDN - Regional Research Delivery Network
SAE - Serious Adverse Event
SAR - Serious Adverse Reaction
SC - Secondary Care
Screening - The process of identifying eligible patients prior to approaching them to determine if they are willing to consent to participate in the study.
SG - Specialty Group
SIV - Site initiation visit
SoECAT - Schedule of Events Cost Attribution Tool
SOP - Standard Operating Procedure
Sponsor - The Institution, Body or Organisation legally responsible for the initiation, management and financing of a research study.
SSC - Study Support Costs
SSS - Study Support Service
Substantial Amendment - An amendment to the protocol or any other study specific documentation, the terms of the REC application or the terms of the CTA application (as applicable) that is likely to affect to a significant degree the: The safety or physical or mental integrity of the subjects of the trial; The scientific value of the trial; The conduct or management of the trial; or The quality or safety of any investigational medicinal product used in the trial.
SUSAR - Suspected Unexpected Serious Adverse Reaction
TMF - Trial Master File
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