Glossary
The world of clinical research can sometimes feel as though it’s full of acronyms and jargon! The Clinical Research and Innovation 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 Eve Dawber in the Clinical Research and Innovation Office at eve.dawber2@nhs.net |
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 NIHR National Institute for Health and Care 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. |
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: 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: https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/research-ethics-committees-overview/ 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 |