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 carer is a relative, friend or partner who provides (or intends to provide, or used to provide) a substantial amount of care to another person on a regular basis, but not necessarily through living with them.
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Academic Training Programme
Central Commissioning Facility
Comprehensive Clinical Research Network
Consent Form (also ICF, Informed Consent Form)
Code of Federal Regulations (US)
In the case of a CTIMP:
For research other than CTIMPs:
The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design conduct and reporting of the study whether or not that person is an Investigator at any particular site.
Collaborations for Leadership in Applied Health Research and Care
A systematically developed statement for practitioners and participants about appropriate health care for specific clinical circumstances.
Clinical research aims to find out the causes of human illness and how it can be treated or prevented. This type of research is based on examining and observing people with different conditions and sometimes comparing them with healthy people. It can also involve research on samples of blood or other tissues, or tests such as scans or X-rays. Clinical researchers will also sometimes analyse the information in patient records, or the data from health and lifestyle surveys.
Clinical trials are research studies involving people who use services, which compare a new or different type of treatment with the best treatment currently available. They test whether the new or different treatment is safe, effective and any better than what already exists. No matter how promising a new treatment may appear during tests in a laboratory, it must go through clinical trials before its benefits and risks can really be known.
Authorisation by a competent authority (MHRA in the UK) to conduct a clinical trial.
Pre-2004 Clinical Trial Arrangements: former method for approval of a clinical trial by the MHRA, now replaced by the Clinical Trials Authorisation.
For for certain ‘Type A’ trials notification of the trial to the MHRA is possible.
Type A trials are those involving medicinal products licensed in any EU Member State if:
See the MHRA website for further information.
A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.
An investigation in human subjects, other than a non-interventional trial, intended:
a) to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products,
b) to identify any adverse reactions, or
c) to study absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products.