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Trust R&D Approval

The procedure for Trust approval depends on the type of study proposed. The following flowcharts explain the processes for portfolio and non-portfolio research:

Approval for Patient Identification Centres
Approval for Research Sites
  1. At the same time as the application for national approval is being submitted, the Chief Investigator must submit the R&D application with the relevant documents. For Patient Identification Centre projects, the R&D application should include a list of all PICs.
  2. For research sites, the Chief Investigator will then be requested to ask all Principal Investigators to complete and submit a Site Specific Information (SSI) form for each NHS Trust in England that is taking part in the study.
  3. Receipt of the Site Specific Information (SSI) forms will mean that Solent NHS Trust can begin the local governance review.
  4. The documents required for approval will depend on the type of study proposed, and IRAS will produce a checklist. Our research office will also be able to advise you accordingly, but typically includes local versions of the following:
    • R&D Form (signed)
    • SSI Form (If applicable – Signed)
    • *Protocol
    • *Participant Information Sheet (Localised with Solent NHS Trust logo)
    • *Consent Form (Localised with Solent NHS Trust logo)
    • Ethics Approval Letter
    • Written confirmation of sponsorship
    • Written confirmation of funding
    • Letter confirming Indemnity / Insurance (please ensure this policy certificate is valid)
    • Chief Investigator CV (Signed and Dated)
    • Principal Investigator CV (Signed and Dated), if applicable
    • Research Team CV(s) (Signed and Dated), if applicable
      Please give consideration to whether you or any of the Research Team will require Letters of Access / Research Passports / GCP Training, etc.
    • Contact details for the person who will be responsible for the uploading / notifying of recruitment figures onto edge. To enable us to give access to edge we will require their email address; telephone number and postal address.
    • Copy of the Clinical Trial Agreement, if applicable
    • UK Clinical Research Network Study Portfolio ID Number, if applicable - http://public.ukcrn.org.uk/search/
    • Evidence of local costings, if applicable

    Please Note: All documents marked with * MUST be dated and have version numbers.

  5. You will need to provide evidence of costings, which you can contact us about.

  6. You will also need to outline measures to ensure data protection concerns are taken into consideration.

  7. The governance review for Portfolio projects will be processed at Solent within 30 calendar days if all the relevant documents have been submitted. Non-portfolio projects aim to be processed within 30 calendar days.