Documents required for R&D approval
Prior to the SSI Form being submitted to the Trust’s R&D Governance Office, researchers should ensure all applicable documents listed below have been submitted if not already done so at the time of registering your study:
- Study Protocol
- Participant Information Sheets and Consent Forms – please ensure the correct version is sent and corresponds with the version that was approved by the Ethics Committee.
- Written confirmation of sponsorship from the organisation acting as sponsor (signature on the IRAS R&D Form from an appropriate administrator at the sponsor may be sufficient)
- Draft Clinical Trial Agreement for review. This is obligatory for industry sponsored CTIMPs
- Draft study costings for review for industry-sponsored studies
- CVs (signed and dated) of research team members*
- Evidence of GCP training for the Principal Investigator*
- Signed Principal Investigator Agreement
- Signed Divisional Director/ Clinical Service Lead approval form
- If applicable a Local ionising radiation risk assessment form (IRMER Form),
- Data Transfer Form
- For no objection studies only you must provide the R&D Governance Office with copies of the protocol, IRAS R&D Form if appropriate, any participant information sheets and consent forms. We would not usually issue other forms to complete.
* CVs and GCP evidence are not required if the R&D Governance Office already holds copies that are no more than 2 years old. We recommend GCP refresher training every 3 years and will require it after 5 years.
The above documents do not need to be submitted as a single package; the R&D Governance Office will routinely prompt for missing documents.