Patient, service user, carer, relative, professional carer, other employee, or member of the public, who consents to take participate in a study. (In law, participants in clinical trials involving medicinal products or a control are referenced as subjects). See also Subject.
See also sample participant screening log for a template to document identification of participants entering pre-trial screening.
Participant Identification Centres (PICs)
Organisations which refer potential participants to a research team at another organisation, but do not conduct trial related activity themselves. If activities such as consent take place, then the site would not be classed as a PIC.
Participant Information Sheet (PIS)
A document explaining all relevant study information to assist the potential subject in understanding the expectations and requirements of participation in a clinical trial.
Patient and Public Involvement
An active partnership between patients and the public and researchers in the research process, rather than the use of people as 'subjects' of research.
Patient and public involvement in research is often defined as doing research ‘with’ or ‘by’ people who use services rather than ‘to’, ‘about’ or ‘for’ them. This would include, for example, involvement in the choice of research topics, assisting in the design, advising on the research project or in carrying out the research.
An appropriate process of independent expert review has demonstrated that the research proposal is worthwhile, of high scientific quality and represents good value for money.
The science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines.
Phase of a Trial
The phases of a clinical trial can generally be categorised in the following terms:
- Phase I - Human pharmacology
- Phase II - Therapeutic exploratory
- Phase III - Therapeutic confirmatory
- Phase IV - Therapeutic use.
Further description of each can be found in Table 1 of the ICH E8: General Considerations for Clinical Trials (PDF, 225 KB).
A control substance (a dummy treatment) that is given to people taking part in a clinical trial. It allows researchers to test for the 'placebo effect'. This is a psychological response where people feel better even though the substance they are taking has no effect. By comparing people's responses to the placebo and to the drug being tested, researchers can tell whether the drug is having any real benefit.
Post Hoc Analysis
From Latin ‘after this’, post hoc analysis consists of looking at the data after the experiment has concluded for patterns that were not specified up front. It is sometimes called by critics, data dredging.
Principal Investigator (PI)
For CTIMPs, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the Investigator is the leader responsible for that team.
For research other than CTIMPs: The person responsible, individually or a leader of the researchers at a site, for the conduct of a study at that site.
A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments.