Case Report Form (CRF)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.
Chief Investigator (CI)In the case of a CTIMP: a) In relation to a clinical trial conducted at a single trial site, the Investigator for that site; or b) In relation to a clinical trial conducted at more than one trial site, the authorised health professional, whether or not he is an Investigator at any particular site, who takes primary responsibility for the conduct of the trial. 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.
Clinical TrialA clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. A Study Type.
Clinical Trial Authorisation (CTA)Authorisation by a competent authority (MHRA in the UK) to conduct a clinical trial.
Clinical Trial Certificate (CTC)Pre-2004 Clinical Trial Arrangements: former method for approval of a clinical trial by the MHRA, now replaced by the Clinical Trials Authorisation.
Clinical Trial Notification Scheme
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: they relate to the licensed range of indications, dosage and form; or they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines. See the MHRA website for further information.
Clinical Trial of an Investigational Medicinal Product (CTIMP)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.
Clinical Trials Directive (CTD) (also known as EU Clinical Trials Directive (EUCTD))Directive 2001/20/EC: On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Clinical Trials Exemption (CTX)Pre-2004 Clinical Trial Arrangements: former method for the approval of a clinical trial by the MHRA now replaced by the Clinical Trial Authorisation.
Clinical Trials Regulations (also known as the UK Regulations or the Regulations)
A term used to describe The Medicines for Human Use (Clinical Trials) Regulations (SI 2004 1031) and its amendments. A brief description of each of the statutory instruments and their relationship with the European Directives can be accessed in this pdf.
Common European Submission Platform (CESP)Provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies via one platform.
ComparatorAn investigational or marketed product (i.e. active control) or placebo, used as a reference in a clinical trial.
Competent Authority (CA)Each member state in the European Economic Area has appointed a competent authority to perform certain functions required by Directive (2001/20/EC). The MHRA (the UK’s licensing authority established under the Medicines Act 1968) is the competent authority in the UK.
Contract Research Organisation (CRO) (also known as Clinical Research Organisation)A service organisation that provides support to the pharmaceutical and biotechnology industries (and other organisations) in the form of research services outsourced on a contract basis.
Control Group / ArmThe groups being compared in the randomized trial. Also referred to as "study groups", "treatment groups", "the arms" of a trial, or by individual terms such as treatment and control groups.
Controlled TrialA type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a "historical control").
Coordinated System for gaining NHS Permission (CSP)The Coordinated System for gaining NHS Permission in England which is: a) a service to Investigators which facilitates set up and approval for research in the NHS b) a standardised process by which NHS organisations provide NHS permission for research. Also sometimes used informally to refer to the information system which supports the process.
Where two or more organisations share a significant interest in a study, they may elect to act as co-sponsors. See the Sponsorship Principles pdf document for further details.