For an overview of the commercial, non-commercial and Papworth Sponsored governance processes, detailing the steps to be taken and all mandatory stages of the process, please click on links provided. 

Research Governance Project Approval System (RGPAS)
All proposed research studies are reviewed at twice monthly Research Governance Project Approval System (RGPAS) meetings to conduct a risk assessment and review governance issues (contracts, indemnity, resources, finances, Trust capacity to conduct the study).

Non-Royal Papworth sponsored studies (includes commercial research)
To discuss the process for obtaining Trust approval for your non-Royal Papworth sponsored study please contact our R&D team.

Which documents do you need to submit for Royal Papworth approval?

  1. Research Ethics Committee letter of favourable opinion
  2. HRA letter of favourable opinion
  3. All Research Ethics Committee/HRA approved study documents e.g. protocol, patient information sheet, patient consent form
  4. IRAS application form (xml and pdf formats of the final signed version)
  5. SSI form or the HRA Statement of Activities file
  6. MHRA letter of no objection (for medicinal safety and efficacy studies)
  7. MHRA letter of no objection (for studies of medical devices which are unlicensed or being used in an unlicensed application)
  8. Approval letters from other regulatory bodies, if applicable e.g. ARSAC, CAGs, GTAC)
  9. Agreed costings
  10. Contract (final agreed and signed version)
  11. PI's C.V, signed and dated within the past three years
  12. PI's GCP cerificate issued within past two years
  13. Material Transfer Agreement (if required)

We will also require a completed risk assessment, Trust departmental approvals and an asset register completion, all of which our Clinical Project Managers will obtain on your behalf.

Royal Papworth sponsored studies
To discuss the process for obtaining sponsorship agreement and Trust approval for your Royal Papworth sponsored please contact the Clinical Project Managers.

All proposed Royal Papworth sponsored studies are discussed at the Research Governance Project Approval System (RGPAS) where the decision will be made whether or not the Trust is able to be the sponsor of the study.

Which documents do you need to submit for sponsorship confirmation for Royal Papworth sponsored studies?

  1. Draft IRAS application form
  2. Draft Protocol
  3. Draft Patient Information sheet
  4. Draft Patient Consent form
  5. Funding agreement
  6. Evidence of independant peer review

Which documents do you need to submit for Royal Papworth approval for non-Royal Papworth sponsored studies?

  1. Research Ethics Committee and HRA letters of favourable opinion
  2. All Research Ethics Committee/HRA approved study documents e.g. protocol, patient information sheet, patient consent form
  3. IRAS application form (xml and pdf formats of the final signed version)
  4. SSI form or the HRA Statement of Activities file
  5. MHRA letter of no objection (for medicinal safety and efficacy studies)
  6. MHRA letter of no objection (for studies of medical devices which are unlicensed or being used in an unlicensed application)
  7. Approval letters from other regulatory bodies, if applicable, e.g. ARSAC, CAGs, GTAC)
  8. Agreed costings
  9. Contract (final agreed and signed version)
  10. CI's C.V, signed and dated within the past three years
  11. CI's GCP cerificate issued within past two years
  12. Material Transfer Agreement (if required)

We will also require a completed risk assessment, Trust departmental approvals and an asset register completion all of which our Clinical Project Managers will obtain on your behalf.