The Leeds Teaching Hospitals NHS Trust


Here you will find a list of the most commonly used terminology that you may come across when reading about Stroke Research and the Stroke Research Studies.
Adverse Event
Adverse Reaction
Coordinating Centre
Consent Form (also ICF, Informed Consent Form)
Chief Investigator - The lead investigator with overall responsibility for the research. In a multisite study, the CI has coordinating responsibility for research at all sites. The CI may also be the PI at the site in which they work. In the case of a single-site study, the CI and the PI will normally be the same person and are referred to as PI.
CRF (i)
Case Report Form - (data collection tools provided by the sponsor on which the clinical data is recorded for each participant, such as weigh, lab results and symptoms
CRF (ii)
Clinical Research Facility - hospital like facility with consulting rooms, patient beds, medical equipment and where research nurses work
Clinical Research Network
Clinical Trials Assistant - person providing coordinating / secretarial support for the running of clinical studies
Clinical Trial of an Investigational Medicinal Product
Delegation of Duties Log
Document detailing who has been delegated each duty by the Principal Investigator of the study
Department of Health (for England)
Data Protection Act
Data Query
An electronic version of the CRF(i)
A clinical assessment of whether the potential participant meets the inclusion and exclusion criteria for the study as described in the protocol
European Clinical Trials Database - a database of all the clinical trials in Europe (held since 1994 in accordance with the EU directive 2001/20/EC
The process of reviewing the protocol to determine whether or not a study can be safely and effectively delivered
Good Clinical Practice - an international ethical and scientific quality standard for designing, recording and reporting studies (the aim of GCP is to ensure the rights, safety and wellbeing of study participants are protected and research data is high quality)
Health Research Authority
Investigators Brochure - a compilation of clinical and pre-clinical pharmacological/biological data relevant to the use of that IMP(s) in human subjects (there is one single IB for all trials using the same IMP)
Informed Consent Form
Investigational Medicinal Product - an unlicensed new drug, an existing drug tested outside it’s licence, or existing drugs tested against each other for their efficacy/safety. The MHRA provide advice to help you decide if your product is an investigational medicinal product.
Researched conducting the clinical study, those researchers who are leading the team are reffered to as CI or PI
Investigator Site File - the file designed for use in organising and collating all essential documentation required to conduct a study in accordance with the principle within GCP
International Standard Randomised Control Trial Number - a simple numeric system for the identification of randomised controlled clinical trials worldwide
Medicines and Healthcare Products Regulatory Agency - The UK Competent Authority and licensing authority for medicines and medical devices
The person designated by the sponsor to perform site visits and docut the monitoring process (the person who checks whether there are any deviations from the protocol and that all source data was transferred into the Case Report Forms correctly)
National Institute for Health Research - established by Department of Health for England in 2006 to provide the framework through which DH will position, manage and maintain the research, research staff and infrastructure of the NHS in England as a virtual national research facility
Principal Investigator - The lead person at a single site designated as taking responsibility within the research team for the conduct of the study
Participant or Patient Information Sheet - an information leaflet given to those who have been invited to participate in a research study.
Research and Development - often the name of the department within the NHS hospitals giving permission to conduct projects within the facilities with patients or staff
Randomised Control Trial - a randomised controlled trial is a clinical study in which two (or more) forms of care are compared with the participants allocated to one of the arms in an unbiased way
Research Ethics Committee - authorised by NRES to review study documents for research taking place in the NHS, or social services. Some REC specialise in Clinical Trials, or topics such as research in children, MCA.
Serious Adverse Event
Serious Adverse Reaction
The process of identifying eligible patients prior to approaching them to determine if they are willing to consent to participate in the study
Site Initiation Visit
Summary of Product Characteristics - smaller version of the investigator brochure with details on pharmacological effects, side effects, but issued for a product that already holds a marketing licence
Standard Operating Procedure
Suspected Unexpected Serious Adverse Reaction - A Serious Adverse Reaction (SAR) which is Unexpected (i.e. its nature and severity is not consistent with the known information about that product from the Investigator’s Brochure or the SmPC) and suspected, as it is not possible to be certain of causal relationship with the IMP
Trial Master File - file with all essential documents held by the Chief Investigator/Sponsor Organisation
World Health Organisation
Please note that this list is not exhaustive, it merely covers the ones you may find most commonly. 

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