Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

Glossary

The world of clinical research can sometimes feel as though it’s full of acronyms and jargon!

The Clinical Research Office has created a glossary of definitions and explanations that you may find useful. We will add to it over time and so if there is a term or abbreviation you feel would be a helpful addition to the glossary, please contact Daniel Lawrence in the Clinical Research Office at daniel.lawrence@sth.nhs.uk

 

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

 

A - back to top

Adoption The process by which a potentially eligible study is accepted for inclusion in the NIHR CRN Portfolio.
ADR Adverse Drug Reaction
AE Adverse Event
ARSAC Administration of Radioactive Substances Advisory Committee
ASR Annual Safety Report
C - back to top
CI Chief Investigator The investigator with overall responsibility for the research. In a multi-site study, the CI has coordinating responsibility for research at all sites.
CLAHRC Collaboration for Leadership in Applied Health Research and Care: Yorkshire and Humber
Consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written signed and dated informed consent form.
CRF Case Record Form/Case Report Form
CRF Clinical Research Facility
CRN Clinical Research Nurses
CRN Clinical Research Network
CSP NIHR Coordinated System for gaining NHS Permission
CSP sign-off A quality assurance process, designed to give assurance that all relevant governance checks have been performed and that the correct documentation is in place before the Governance Report is issued.
CTA Clinical Trial Administrator
CTA Clinical Trials Agreement
CTA Clinical Trial Authorisation
CTIMP Clinical Trial of an Investigational Medicinal Product: Any investigation in human subjects, other than a non-interventional trial, intended:
(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
(b) to identify any adverse reactions to one or more such products, or
(c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products.
D - back to top
DH Department of Health
DMC Data Monitoring Committee
DPA Data Protection Act
DPO Data Protection Officer
E - back to top
Epigeum Online GCP training course available through the Clinical Research Office, Sheffield
EudraCT European Clinical Trials Database
F - back to top
FDA Food and Drug Administration
G - back to top
GCP Good Clinical Practice
GTAC Gene Therapy Advisory Committee
H - back to top
HPA Health Protection Agency
HSE Health & Safety Executive
HTA Human Tissue Authority
HTA Health Technology Assessment
HT Act Human Tissue Act
HTD Health Technology Devices
I - back to top
IB Investigator Brochure
ICH International Conference on Harmonisation
ICR Institute of Clinical Research
IMP Investigational Medicinal Product
Industry-Sponsored studies These studies are funded and sponsored by a commercial company but hosted by the NHS
INN International non-proprietary name
IP Intellectual Property
IRAS Integrated Research Application System
https://www.myresearchproject.org.uk/
IRB Institutional Review Board USA
IRMER Ionising Radiation Medical Exposure Regulations
ISR Independent Scientific Review
ISRCTN International Standard Randomized Controlled Trial Number
L - back to top
LoA Letter of Access
M - back to top
MA Marketing authorisation
MAH Marketing authorisation holder
MCA Medicines Control Agency
Medical Device Medical devices may be classified as Class I, Class IIa, IIb and III, with Class III covering the highest risk products. Classification of a medical device will depend upon a series of factors, including: how long the device is intended to be in continuous use, whether or not the device is invasive or surgically invasive, whether the device is implantable or active whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
MHRA Medicines and Healthcare products Regulatory Agency: MHRA (Medicines) is the competent authority for the UK in relation to the EU Directive and the Clinical Trials Regulations. MHRA (Devices) is the competent authority for the UK in relation to the Medical Devices Regulations 2002.
MIMP Medical Imaging and Medical Physics, STH
Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted and recorded in accordance with the protocol, Standard Operating Guidelines (SOP’s), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
MPE Medical Physics Expert
MRC Medical Research Council
Multi-centre/ Multi-site Multi-centre or multi-site studies are those with more than one participating NHS Organisation, located within more than one locality
N - back to top

NEAT New and Emerging Technology
NICE National Institute for Clinical Excellence
 

NIHR National Institute for Health Research

 

Non-Portfolio, Non-Industry studies These studies do not meet the eligibility criteria for being adopted onto the NIHR Portfolio. They are often research studies that are being undertaken for education purposes (usually at Masters or Doctorate level). This category also includes studies which are funded internally through department or directorate funds.
NPSA National Patient Safety Agency
NRES National Research Ethics Service; http://www.nres.nhs.uk
NRR National Research Register

P - back to top
Participant Information Sheet (PIS) A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial.
PICTF Pharmaceutical Industry Competitive Task Force
PI Principal Investigator The Investigator responsible for the local research site. There should be one PI for each research site. In a single site study the CI and PI will normally be the same person.
PIL Patient Information Leaflet
PIS Patient Information Sheet (see above)
PK Pharmacokinetic
PL Product Licence
Portfolio Study The National Institute for Health Research (NIHR) has a Portfolio of clinical research studies that are of high-quality and clear value to the NHS. 
You can apply for your study to be adopted onto the Portfolio if it meets the NIHR’s eligibility criteria. When your study is adopted onto the Portfolio the benefits potentially include access to research support staff, NHS service support costs and the rapid approval of your study through the NHS research governance systems.
Details about the NIHR Portfolio, eligibility criteria and benefits can all be found at:

http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/

Potentially Eligible A study is “potentially eligible” for the NIHR CRN Portfolio if:
- it fulfils the DH eligibility criteria but information is missing from the CSP Application Form (formerly PAF) or clarification is being sought from the CI; or
- it is funded by an organisation which may fulfil the criteria for NIHR Partner Organisation status but the funder has yet to be confirmed as an NIHR
Partner Organisation by the DH; or
- it fulfils the first two eligibility criteria above, but the study has evoked a policy query which needs to be resolved by the DH; or
- it is funded by industry, a non-UK organisation, or is an IIT, and is awaiting adoption.
Protocol A document that describes the objectives, study design, methodology, statistical considerations or other methods of data analysis and organisation of a research study.
Q - back to top
QA Quality Assurance
QC Quality Control
QP Qualified Person
QOL Quality of Life
R - back to top
RCT Randomised Control Trial
RDSU Research & Development Support Unit
REC Research Ethics Committee
RGF Research Governance Framework: The NHS Research Governance Framework (RGF) defines the broad principles of good research governance and is key to ensuring that health and social care research is conducted to high scientific and ethical standards. The latest version of the Research Governance Framework is available from the Department of Health website.
RIDDOR Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
RPA Radiation Protection Advisor
RPO Radiation Protection Officer
S - back to top
SADR Serious Adverse Drug Reaction
SAE Serious Adverse Event
SDO NHS Service Delivery and Organisation
SDV Source Data Verification
Single centre/ single site Single site studies are those with only one participating NHS Organisation.
SME Subject matter expert
SmPC Summary of product characteristics
SMO Site Management Organisation
SOP Standard Operating Procedure
Sponsor The sponsor is the individual, organisation, or group of individuals or organisations that take on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study.
SSC Study Site Coordinator
SSI Site Specific Information
STH Sheffield Teaching Hospitals NHS Foundation Trust
Support Services Sheffield Teaching Hospitals and the University of Sheffield have a variety of support services that assist researchers including Imaging, Pharmacy and Laboratory Medicine.
SUSAR Suspected Unexpected Serious Adverse Reaction
U - back to top

UKCC UK Cochrane Centre
UKCRC UK Clinical Research Collaboration
UKCRN UK Clinical Research Network
UKECA United Kingdom Ethics Committee Authority