Every research study that falls within the scope of the Medicines for Human Use (Clinical Trials) Regulations (SI 1031/20/2004), termed ‘the Regulations’ and the UK Policy Framework for Health and Social Care Research v3.2 10/10/2017 termed ‘the Framework’ must have a nominated Research Sponsor.
For studies which fall within the scope of the Regulations the Sponsor is defined as: ‘An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial’.
For studies outside the Regulations but within the scope of the Framework a Sponsor is defined as: ‘the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor and finance a study’.
The Clatterbridge Cancer Centre will protect the rights, safety and wellbeing of all participants involved in clinical research and to assure the quality of their care when we act as Sponsor for a research study assuring timely set-up and full research governance and oversight from our RM&G Team and working in partnership with the Liverpool Cancer Trials Unit as preferred service provider.
We will provide all support necessary for the Chief Investigator to develop and then deliver the study. The process has been pared to be as streamlined as possible whilst retaining robust governance and patient safety and wellbeing.
- The CI should register the project with the RM&G team and should either indicate that they wish for CCC to act as Sponsor or indicate that the study is to be sponsored by a different organisation.
- For those studies where the CCC clinician is CI but CCC is not acting as Sponsor but as lead site, this should be flagged with the Research Partnerships Manager at the earliest opportunity.
- The CI should indicate the level of input required from any CCC staff or departments and request input; this should be confirmed in writing to the Research Governance and Quality Manager (RGQM).The request should be made in a timely manner and as early as possible to assure enough lead time for requested staff/ input to be given.
- The CI should complete a Sponsorship Application form available from the RGQM if they wish for CCC to act as Sponsor.
- The CI should also arrange for peer review to be submitted for consideration for studies. CNG support is acceptable, or review by the grant awarding body is acceptable, if the proposal is already funded. If the project is in the early stages, the CI should contact the RQQM and CCC will provide all support in the grant application process.
- For studies of a Clinical Trial Investigational Medicinal Product (CTIMP) or interventional studies, the trial should be run using a Clinical Trials Unit. The Liverpool Cancer Trials Unit (LCTU) is CCC’s preferred provider and work closely with CCC RM&G.
- The RGQM should ensure that for interventional studies, for which CCC is to act as Sponsor, the study documentation is circulated to the Sponsorship Committee for review.
- The RGQM will co-ordinate the responses from the Sponsorship Committee and relay the decision/ any further requests for documentation/ clarification to the CI.
- The Research Manager will issue a letter of Sponsorship in principle in the first instance listing any conditions which must be met before full Sponsorship is given by CCC.Once the conditions are met, full Sponsorship will be given.
- The RM&G Team with the CI and the LCTU will have a start up meeting agreeing timelines and process for study development and submissions to REC/ HRA and Competent authority.The LCTU provides all aspects of study management and development services, CCC provides contracts management, governance oversight and support.