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 Reprt 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: 

  • discover or verify the clinical, pharmalogical or other pharma-codynamic effects of one or more medicinal products
  • identify any adverse reactions to one or more such products
  • study absorbption, distribution, metabolism and excretion of one or more such products
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 artifical 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:
  • given freely after that person is informed of the nature, significance, implications, inconveniences and risks of the study and is either:
  • evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate consent, or
  • if the person is unable to sign or mark a document so as to indicate consent, is given orally in the presence of at least one witness and recorded in writing
Investigational Medicinal Product The subject should also be informed of his or her right to withdraw from the study at any time. 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:
  • used, formulated or packaged in a way different from the form of the product authorised under the authorisation
  • used for an indication not included in the summary of product characteristics under the authorisation for the product
  • used to gain further information about the form of that product as authorised under the authorisation
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

Main REC In the case of multi-site studies, the REC undertaking the ethical review of an application. The main REC may be a LREC or a MREC
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:
  • the products are prescribed in the usual manner in accordance with the terms of that authorisation
  • the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice
  • the decision to prescribe a particular medicinal product i s clearly separated from the decision to include the patient in the study
  • no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question 
  • epidemiological methods are to be used for the analysis of the data arising from the study 

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:
  • a product has been manufactured in the UK in accordance with Good Manufacturing Practice (GMP), or
  • an overseas manufacturing site operates in accordance with standards equivalent to EU GMP

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:
  • results in death
  • is life-threatening
  • requires hospitalisation or prolongation of existing hospitalisation
  • results in persistent or significant disability of incapacity
  • consists of a congenital anomaly or birth defect 
Site Specific Assessment An assessment, under the NHS REC system, of the suitability of the investigator, site and facilities made for any study with a Principal Investigator at each research site (The application should be made by the PI using Part C of the COREC application form)
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:
  • in the case of a product with a marketing authorisation in the summary of product characteristics for that product
  • in the case of any other investigational medicinal product, in the investigator's brochure relating to the study in question

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