Responsibilities for Imperial or ICHT as a sponsor
The sponsor is responsible for ensuring appropriate arrangements are in place for; the initiation, management and financing of Imperial research projects. This means that where Imperial is the sponsor, it is responsible for the following;
Ensuring appropriate arrangements are in place for:
- Research teams to access sufficient resources to deliver their research as proposed.
- The collection of high quality and accurate data.
- The management and monitoring of research, to ensure it is carried out in accordance with the approved protocol (or proposal) and regulatory requirements.
- Recording and reporting of significant developments as research proceeds, either in relation to the safety of individuals or scientific direction. In particular, ensuring appropriate arrangements for the recording and reporting of serious adverse events/reactions of any kind.
- Approving modifications to the design of clinical studies, obtaining any regulatory approvals and implementing them.
- The conclusion of a study, including plans for disseminating findings.
Imperial is also responsible for ensuring that:
- Research proposals respect the dignity, rights, safety and well-being of participants and the relationship with care professionals.
- Only research of high scientific quality and good value for money is undertaken.
- An appropriate Research Ethics Committee has approved all clinical research projects. For further information see the Committees pages.
- For clinical trials of investigational medicinal products, the Chief Investigator obtains a clinical trial authorisation and all trial arrangements comply with the law.
- All clinical research being undertaken through or within Imperial, including research undertaken by students as part of their training, is formally registered.
- The Chief Investigator and other key researchers have the necessary expertise and experience to conduct research as proposed.
- Agreement has been reached about compensation in the event of harm to research participants. For further information about this, please see our section on insurance.
- Auditing or inspection by relevant authorities is permitted and assisted.
As part of the sponsor remit to demonstrate oversight and project research compliance RGIT may audit research studies at any time. If your project is selected for audit then we will contact you with more information regarding what an audit will entail. You may also request a voluntary audit if you wish to check compliance of your study.
Normally the audit process takes around 1-3 days with 2-3 auditors and will involve assessment of the projects Trial Master File, CRFs, facilities and source data verification. The audit will check that the study is running to ICH GCP guidelines, SOPs and any other applicable regulatory requirements.
In some cases an audit may be triggered if concerns are raised regarding a research project or a breach of GCP has been identified.