Chief investigator (CI)
The Investigator with overall responsibility for the research. In a multi-site study the CI has co-coordinating responsibility for research at all sites. In relation to a clinical trial of an investigational medicinal product, CI has specific, defined responsibilities.
Clinical trial is commonly used in the academic sector to refer to any prospective evaluation of a health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle (e.g. dietary) advice.A clinical trial of an investigational medicinal product (CTIMP) is a legal definition and describes those trials which fall within the scope of the Medicines for Human Use (Clinical Trials) Regulations 2004.
Clinical Trials Regulations
The Medicines for Human Use (Clinical Trials) Regulations (2004) is the law within the UK that applies to research into the safety and/or efficacy of investigational medicinal products. These Regulations are how the EU Clinical Trials Directive was transposed into UK legislation. Further information can be found in the Clinical Trials Tool Kit.
The ability of a person, given the necessary information, to understand the nature and the consequences of the proposed procedure or treatment, and to use that information to make a valid choice in accordance with their own fundamental values.In relation to research this would be the ability to understand the research project and their proposed role with in that project and to make a decision as to whether they would like to participate or not based on this information.
Competent Authority (CA)
An organisation (usually a governmental body) that has a statutory role to ensure compliance with relevant current legislation. This can involve licensing specific activities, performing inspections, granting approvals and/or developing codes of practice.
The voluntary agreement of an adult or competent child, based on adequate knowledge and understanding of the relevant information, to participate in research. Consent is often recorded by a signature on a consent form.
A written record of the study participant's decision to take part in the research study. A template is available on the NRES website.
Central Office for Research Ethics Committees, now called National Research Ethics Service (NRES).
Clinical Record Form/Case Report Form, also used in a different context to mean Clinical Research Facility.
Clinical Trial Authorisation - statutory approval from the MHRA for a Clinical Trial of an Investigational Medicinal Product.Is also used to describe a Clinical Trial Agreement: a legal agreement drawn up between parties to define roles and responsibilities in the initiation, conduct and management of a clinical trial.
Clinical Trial of an Investigational Medicinal Product, i.e. a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. The European Commission have developed an algorithm to enable you to determine whether or not your study falls within the scope of the regulations (available from the Clinical Trials Tool Kit)