Document 3 Glossary of Terms
Clarification is given here of the meaning of some of the terms used in the application
form, as used in Governance Arrangements for Research NHS Ethics Committees and the
Research Governance Framework for Health and Social Care. These meanings are
broadly compatible with their use in other regulatory documents, although sometimes such
documents use alternative words.
ARSAC Administration of Radioactive Substances Advisory
Care organisation The organisation(s) responsible for providing care to patients
and/or users and carers participating in the study e.g. NHS
Trust, private sector care provider, Care Trust.
Caldicott principles A set of principles recommended by the Caldicott Committee
to the NHS to guide the use of and transfer of patient-
identifiable information. See www.dh.gov.uk/ipu/confiden
Chief Investigator (CI) (a) in relation to a clinical trial or other research conducted at
a single trial research site, the investigator for that research
(b) in relation to a clinical trial or other research conducted at
more than one trial research site, the authorised health care
professional or other researcher, whether or not he/she is an
investigator at any particular research site, who takes
primary responsibility for the conduct of the research,
including co-ordinating the principal investigators who take
the lead at each research site.
This individual is sometimes known as the Co-ordinating
Clinical Trial Any investigation in human participants, other than a non
interventional trial, intended –
a. to discover or verify the clinical, pharmacological and/or
other pharmocodynamic effects of one or more
b. to identify any adverse reactions to one or more such
c. to study absorption, distribution, metabolism and
excretion of one or more such products with the object
of ascertaining its (their) safety or efficacy of those
Clinical Trial or Research Protocol A document that describes the objectives, design,
methodology, statistical considerations and organisation of a
clinical trial or other research.
DMC Data Monitoring Committee. This is sometimes called by
other names, e.g. Data Monitoring and Safety Committee
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Employing organisation(s) The organisation(s) employing the Chief Investigator, co-
ordinating and/or Principal Investigator and/or other
researchers. The organisation employing the Chief
Investigator, and/or the Principal Investigator will normally
hold the contract(s) with the funder(s) of the study.
Organisations holding contracts with funder(s) are
responsible for the management of the funds provided.
Funder(s) Organisation(s) providing funding for the study through
contracts, grants or donations to an authorised member of
either the employing and/or care organisation.
GAfREC Governance Arrangements for NHS Research Ethics
Committees. See www.corec.org.uk
Health Authority A body established by the National Health Service to oversee
health matters for the population of a defined area. From
October 2002, these have been replaced by “Strategic
Health Authorities” (qv).
Host organisation The NHS or other organisation where the research will take
Human biological materials Any biological samples taken from an individual e.g.
blood, biopsy material, bodily samples, teeth, saliva, hair,
nails. It includes substances extracted from these such as
DNA and RNA.
Any research involving eggs, sperm or embryos is dealt with
by the Human Fertilisation and Embryology Authority.
IRMER Ionising Radiation (Medical Exposures) Regulations 2000
Investigators Brochure A document containing a summary of the clinical and non-
clinical data on the investigational medicinal product which
are relevant to the study of the product or products in human
MHRA The Medicines and Healthcare products Regulatory Agency.
This was formed by merging the previous Medicines Control
Agency and the previous Medical Devices Agency.
Multi-centre clinical trialA clinical trial conducted according to a single protocol but at
more than one research site, and therefore usually by more
than one investigator.
No Local Investigator studies Multi-research site studies with a Chief Investigator and
local collaborators who will be carrying out limited
procedures not requiring the appointment of a Principal
Investigator and will not therefore require research site-
specific assessment (see below).
Participants Patients, users, relatives of the deceased, professional
carers or members of the public agreeing to take part in the
study. In some legal and regulatory documents the term
“subject” is used instead.
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For research where there is no actual patient contact, e.g.
that which is based entirely on data or stored biological
samples, the word “participant” is used to refer to the human
source of the data or sample.
Personal data In the context of the 1998 Data Protection Act, data about
living people who can be identified from the data, or from
combinations of the data and other information which the
person in control of the data has, or is likely to have in future.
PIAG The Patient Information Advisory Group, which advises the
Secretary of State on use of powers provided by section 60
of the Health and Social Care Act 2001.
PIS Patient Information Sheet
Principal Investigator The Principal Investigator is the person who is responsible
for the research at a research site. One Principal Investigator
per research site. In relation to a clinical trial or other
research, the authorised health professional or researcher
responsible for the conduct of the research at a research/trial
research site. If the research is conducted by a team of
researchers at a trial research site, the Principal Investigator
is the leader responsible for that team.
Research Ethics Committee The committee convened to provide independent advice
to participants, researchers, funders, sponsors, employers,
care organisations and professionals on the extent to which
proposals for the study comply with recognised ethical
Research Governance For details see www.dh.gov.uk/research
Researchers Those involved in conducting the study.
Research site A hospital, health centre, surgery or other establishment or
facility at or from which a clinical trial, or any part of such a
trial, or other research is conducted.
Research supervisor The person who, when the lead applicant is inexperienced,
will share the responsibility for the ethical and scientific
conduct of the research.
Serious Adverse Event means any adverse event, adverse reaction or unexpected
adverse reaction, respectively that
a. results in death
b. is life-threatening
c. requires hospitalisation or prolongation of existing
d. results in persistent or significant disability or incapacity,
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e. consists of a congenital anomaly or birth defect
Research site-specific assessment This is limited to:
the suitability of the local researcher
the appropriateness of the research environment facilities
Sponsor The individual, company, institution or organisation which
takes on ultimate responsibility for the initiation, management
(or arranging the initiation and management) of and/or
financing (or arranging the financing) for that clinical trial.
The sponsor takes primary responsibility for ensuring that the
design of the study meets appropriate standards and that
arrangements are in place to ensure appropriate conduct and
reporting. The sponsor is usually, but does not have to be,
the main funder. It can be the lead employer of the research
team, or the lead health or social care organisation.
Strategic Health Authority A body established under the National Health Service Act
1977 as substituted by section 1(2) of the National Health
Service Reform and Health Care Professions Act 2002 in
England. It covers a defined geographical area and its
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