Sponsorship
Trial Planning Phase
The Sponsorship station follows the Risk Assessment station and precedes a parallel process in which the Protocol is developed and R&D Consultation takes place. Sponsorship is a legal requirement which is relevant to all trials. This station is part of the 'trial planning phase' group of stations.
Sponsorship
For Clinical Trials of Investigational Medicinal Products (CTIMPs) or an IMP/Device trial, the term sponsor is defined as: the person who takes responsibility for the initiation, management, and financing (or arranging the financing) of the trial.
A sponsor is required for all studies conducted under the UK Policy Framework for Health and Social Care Research. For non-commercial trials, securing a sponsor can take time, so it is important to identify a sponsor (or sponsors) early in the planning process. The UK Policy Framework outlines the sponsor’s responsibilities. Additionally, the Health Research Authority (HRA) offers specific guidance on the roles and responsibilities of sponsors conducting CTIMPs.
Before starting a trial, the sponsor should define, establish, and allocate all trial-related duties and functions. A trial may also have more than one sponsor. The NHS R&D Forum’s Sponsorship Principles document (.PDF) provides further details on all aspects of non-commercial trial sponsorship.
Legal Representatives
Where the sponsor is not established in the UK or in a country on the approved country list (currently, this includes countries in the European Union (EU) and the European Economic Area (EEA), a legal representative must be established in either the UK or a country on the approved country list.
The legal representative acts as the sponsor's point of contact with the Medicines and Healthcare products Regulatory Agency (MHRA) and handles any legal or regulatory matters on the sponsor's behalf. The HRA’s roles and responsibilities webpage provides additional information on the roles and responsibilities of legal representatives.
Further Reading
- MHRA Blog: Sponsor Oversight- Part 1.
- MHRA Blog: Sponsor Oversight – Part 2.
- World Health Organisation (WHO): Guidance for Best Practice for Clinical Trials.
- Association of the British Pharmaceutical Industry (.PDF): Insurance and compensation in the event of injury in Phase I clinical trials (.PDF).
- NHS R&D Forum: Resource Exchange.