Definitions for terms commonly used in relation to research governance and health and social care research.
Glossary
A
| Adult | A person who has reached the age of 16 years old |
| Adverse Event | Any untoward medical occurrence in a person involved in a a clinical study to which a medicinal product has been administered, including occurences which are not necessarily caused by or related to any dose administered to that person |
| Allogenic | Being genetically different although belonging to or obtained form the same species e.g. human donor cells |
| Authorised REC | A Research Ethics Committee established under the governance arrangments for REC but not recognised by UKECA. An athorised REC may review all applications except those relating to clinical trials of investigational medicinal products |
| Autologous | Derived or transferred form the same body as the individuals |
B
| Blinding | A procedure in which one or more parties involved in a trial are kept unaware of the particular courses of treatment being employed |
C
| Case Report Form | A printed or electronic document which records all of the informaiton required in the protocol anout each trial subject that needs to be reported to the sponsor. |
| Chief Investigator | The investigator responsible for a research site where the study involves specified procedures requiring site specific assessment. There should be one CI for each research site. In the case of a single-site study the CI and Principle Investigator will normally be the same person. |
| Clinical Trial |
Any investigation of human subjects, other than a non interventional trial, intended to:
|
| Comparator | A product used as a reference in a clinical trial. |
D
| Declaration of Helsinki | The Declaration of Helsinki adopted by the World Medical Association in June 1964 and subsequently amended |
| Domain | The area covered by the strategic Health Authority (England), a Health Board (Scotland), a regional office of the NHS Wales Department or the whole of Northern Ireland |
E
| Essential Documents | Documents which individually and collectively permit evaluation of the conduct of a research project/trial and quality of the data produced |
| EudraCT | European Clinical Trials Database |
| Ex vivo | In an artificial environment outside the living organism |
H
| Healthcare Professionals | A; Doctor, Dentist, Nurse, Pharmacist, registered Opthalmic Optician or other officially registered health professional |
I
| Informed Consent | Consent that a person has agreed to take part in a clinical study where the decision is:
|
| Investigational Medicinal Product | A pharmaceutical form of an active substance or placebo being tested, used or to be used, as a reference in a clinical trial. It includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial:
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| Investigators Brochure | A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects |
| In vitro | In an experimental situation outside the organism, e.g. biological or chemical work done in a test tube (in vitro is Latin for "in glass") rather than in living systems |
| In vivo | In a living cell or an organism |
M
| Manufacturing Authorisation | An authorisation to manufacture, assemble or import an investigational medicinal product which has been granted by the licensing authority (the MHRA) |
| Minor | A person under the age of 16 years |
N
| Non Interventional Trial | A study of one or more medicinal products which have a marketing authorisation, where the following conditions are met:
|
P
| Principal Investigator | The person with overall responsibility for a research study. For multi-site studies there will also be Principal Investigators at each research site who have responsibility for the study at that site |
| Protocol | A document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial |
Q
| Qualified person | The person responsible for the final despatch of an investigational medicinal product in a clinical trial. They may be required, for example, to certify that:
|
R
| Recognised REC |
A Research Ethics Committee legally recognised by United Kingdom Ethics Committee Authority (UKECA) to give an ethical opinion on a clinical trial of an investigational medicinal product to be undertaken anywhere in the UK |
S
| Serious Adverse Event | Any serious adverse event, reaction or unexpected adverse reaction that:
|
| Site Specific Assessment | An assessment, under the NHS REC system of Non-NHS sites, applicable to CTIMPs and Medical device studies only. |
| Sponsor | The organisation that takes responsibility for the initiation, management and financing of a clinical study. For more information, see our sections on the sponsor or the sponsor agreement process |
| Subject | An individual, whether or not a patient, who participates in a clinical study. They may be a recipient of a treatment/product or be involved without this, as a control |
T
| Trial Master File | A standard central orderly filing system which allows the effective storage and location of the large volume of regulatory and approvals documents needed for clinical research. The regulatory documents within the TMF should be maintained alongside case report forms and source documentation. The system could be in the form of a single project file or a number of files/filing cabinets, depending on what is deemed most appropriate |
U
| Unexpected Adverse Reaction | An adverse reaction the nature and severity of which is not consistent with the information about a medicinal product as set out:
|
X
| Xenogeneic cells | Non-human cells |
| Xenotransplantation | The transplantation of tissue and organs between different species, and in particular the transplantation of animal tissue into humans |