This jargon buster or glossary of words contains the definitions of some of the terms commonly used in public involvement in research. It is not a complete list of all the words you might come across. The original definitions were developed for INVOLVE by TwoCan Associates working in consultation with a panel of researchers and a panel of people who use services, and we add to them continually.
The jargon buster can be searched by clicking on one of the letters below or browsing all terms.
A medicinal product may only be placed on the market in the European Economic Area (EEA) when a marketing authorisation has been issued by the competent authority of a Member State (or EEA country) for its own territory (national authorisation) or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorisation).
The entity that has been granted a Marketing Authorisation. Marketing Authorisation Holders must be established within the EEA.
Mental Capacity Act
model Clinical Investigation Agreement
model Clinical Investigation Agreement: for medical devices, covers the running of the study, not design of prototype or design of protocol; standard template for the UK (use is not obligatory)
Medicines for Children Research Network
model Clinical Trial Agreement
model Clinical Trial Agreement: for IMP studies with commercial sponsor/CRO conducted; standard template for the UK (use is not obligatory)
Any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or related article
a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
The MHRA is the competent authority for the UK in relation to the Directive 2001/20/EC and the Clinical Trials Regulations, and for Medical Devices, the competent authority in relation to the Medical Devices Regulations 2002.
INVOLVE uses this term to cover:• patients and potential patients• people who use health and social care services• informal (unpaid) carers• parents/guardians• disabled people• members of the public who are potential recipients of health promotion programmes, public health programmes, and social service interventions• groups asking for research because they believe they have been exposed to potentially harmful substances or products (for example pesticides or asbestos)• organisations that represent people who use services.
Other organisations have different definitions of this term.
Provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. It makes it clear who can take decisions, in which situations, and how they should go about this.
The research provisions of the Mental Capacity Act 2005 do not apply to the conduct of CTIMPs.
A mentor is a person willing to share their experience, knowledge and wisdom to help, guide and support someone who is less experienced. Mentors act as friends, teachers and advisers. A person who is newly involved in research can ask for a mentor to help them adjust to their new role.
Combining data from multiple independent studies. May be undertaken in evidence syntheses.
The term methodology describes how research is done – so it will cover how information is collected and analysed as well as why a particular method has been chosen.
Medicines for Human Use (Clinical Trials) Regulations: SI 2004:1031 and subsequent amendments 2006:1928, 2006:2984 ,2008:941, 2009:1164 and 2010:1882 are the UK Statutory Instruments translating EU directives 2001/20/EC and 2005/28/EC into UK law, laying down the legal requirements for conducting CTIMPs in the UK
Mental Health Research Network
In relation to a CTIMP, defined in ‘The Medicines for Human Use (Clinical Trials) Regulations’ as a person under the age of 16.
model Non-Commercial Agreement: for clinical research studies; standard template for the UK (use is not obligatory)
The person designated by the sponsor to perform site visits and conduct the monitoring process; eg check whether there are any deviations from the protocol and that all source data was transferred into the Case Report Forms correctly