Sponsorship is required for studies under the Research Governance Framework(s) including trials that that fall within the scope of the Clinical Trial Regulations. It may take some time to secure a sponsor(s), so identification of the sponsor must be considered early in the planning process.
For Clinical Trials of Investigational Medicinal Products (CTIMPs), the European Commission Directive 2001/20/EC define the sponsor as: An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.
The sponsor therefore is not simply responsible for ensuring there are adequate funds for the trial and for CTIMPs; the Clinical Trials Regulations define legal responsibilities that the sponsor must arrange to carry out. These legal responsibilities should not be confused with liability for the harm of a subject.
Before initiating a trial, the sponsor should define, establish and allocate all trial-related duties and functions. The NHS R&D Forum Sponsorship Principles document (pdf, 103.44 KB) provides a comprehensive summary of the legal responsibilities that an organisation sponsoring a CTIMP must arrange to carry out. This document also describes various models of sponsorship that are possible under the Clinical Trials Regulations and the allocation of responsibilities, duties or functions.
For CTIMPs, the person(s) responsible for the sponsor’s functions must be named on the Clinical Trial Authorisation (CTA). If the sponsor of a CTIMP with sites in the European Economic Area (EEA) does not reside within the EEA, a legal representative should be appointed. Further guidance can be found in the Sponsorship Principles document which also includes advice and future developments for UK sponsors of international CTIMPs.
As of 21 July 2014, sponsors are also responsible for the mandatory posting of clinical trial summary results within EudraCT. Results should be submitted within six or twelve months following the end of a trial, depending on the type of trial.
Sponsor approval may be sought for data sharing requests. A Data Sharing Guidance document has been produced as part of an MRC Hubs for Trials Methodology Research funded research project, which summaries good clinical practice principles to follow when sharing individual participant data from publicly funded clinical trials.
In England, NHS organisations that sponsor trials, conduct these activities in line with The Research support Services Framework. Please see Annex 5 of the Research Support Services Framework Documents.
Resources relation to Indemnity and Insurance:
- Insurance and compensation in the event of injury in Phase I clinical trials: Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical Contract Research Association, in consultation with the Department of Health and the National Research Ethics Service.
- EudraCT trial results: modalities and timing of posting document.