Glossary

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

An experiment in which two or more interventions, possibly including a control intervention or no intervention, are compared by being randomly allocated to participants. In most trials one intervention is assigned to each individual but sometimes assignment is to defined groups of individuals (for example, in a household) or interventions are assigned within individuals (for example, in different orders or to different parts of the body).

Committee established to provide participants, researchers, funders, sponsors, employers, care organisations and professionals with an independent opinion on the extent to which proposals for a study comply with recognised ethical standards.  For CTIMPs, the ethics committee must be one recognised by the United Kingdom Ethics Committee Authority. The REC undertaking the ethical review of an application is also known as the Main REC.

Where the term ‘ethics committees’ has been used in the Toolkit, it denotes the ethics committees in all member states that have approved a multinational clinical trial.

The UK Health Departments' Research Governance Frameworks (RGFs) documents a set of standards and principles for carrying out health related or social/community care research in the UK. It is mandatory for all research taking place in the NHS and using NHS resources. It aims to improve research and safeguard the public by:

• enhancing ethical awareness and scientific quality
• promoting good practice
• reducing adverse incidents and ensuring lessons are learned
• forestalling poor performance and misconduct.

Country specific versions of the Framework have been published: England, Scotland, Wales (PDF, 675 KB) and Northern Ireland (PDF, 350 KB).

Provides a mechanism for assuring NHS organisations of the pre-engagement checks conducted on a researcher; and other standardised procedures for handling the HR arrangements for researchers.

The NIHR has established the Research Support Service in England to help researchers develop and design high quality research proposals for submission to national, peer-reviewed funding competitions for clinical, applied health and social care research. The RSS replaces the NIHR Research Design Service (RDS) and NIHR Support Funding for Clinical Trials Units which came to an end on 30 September 2023. 

Those conducting a trial (or study).

See MRC/DH/MHRA Joint Project: The Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products (PDF, 247 KB) and the MHRA website for further information.