Sponsorship is a fundamental part of clinical research and all healthcare research studies involving humans, their tissue and/or data must have a named Sponsor.
If you are a University of Aberdeen or NHS Grampian employee, or student, and your research involves humans, their tissue and/or data, contact the Research Governance Team as soon as possible to begin the sponsorship process.
Sponsorship MUST be in place, before you can apply to REC, MHRA and R & D for further Approvals (REC/MHRA/R & D).
The following is an example of the documents that the Research Governance Team will need to see before beginning the Sponsorship process:
- Ethics / R&D
- IRAS Forms (submitted to Sponsor as full dataset PDF document)
- Any adverts
- Patient Information Sheet
- Informed Consent Forms
- GP letter
- Any patient recorded outcomes
- Diary cards
- CVs and GCP certificates of trial staff
- Sponsor Registration Form
- Evidence of peer review
- Evidence of funding
- Investigator Brochure or SMPC for studies involving drugs.
You should also start preliminary discussions with the Research and Innovation at this stage to discuss potential contract and/or formal agreement requirements.
The Research Governance Team will:
- Risk assess your project to determine whether sponsorship will be granted
- Advise you on study documentation, such as Protocol, Participant Information Sheet and Informed Consent Forms
- Provide advice on all aspects of running your study
- Discuss any research governance and regulatory issues with you
- Confirm or arrange appropriate Insurance for your study
- Refer the study to the Clinical Study Oversight Group for a full risk assessment if deemed necessary.
Remember: Any changes to your approved study MUST be approved by your Sponsor first.
Once all the documents have been reviewed by the Sponsor, and any required changes have been made, sponsorship will be confirmed to the Investigator and permission given to apply for further approvals.