Trust Approval

 

 | Non- Papworth Sponsored Studies (incudes Commercial)Papworth Sponsored Studies |

 

All research projects that  involve PHFT patients, their data or tissue, facilities or staff require NHS Permission in accordance with the NHS Research Governance Framework before they can be carried out at Papworth NHS Foundation Trust.

Research Governance 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 Papworth Sponsored Studies (includes Commercial research)

To discuss the process for obtaining Trust approval for your non-Papworth sponsored please contact papworth.randdenquiries@nhs.net

Which documents do you need to submit for 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 Clincial Project Managers will obtain on your behalf.

 

Papworth Sponsored Studies

To discuss the process for obtaining  Sponsorship Agreement and Trust approval for your Papworth sponsored please contact the Clinical Project Managers.

All proposed 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 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 Papworth approval for non 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 Clincial Project Managers will obtain on your behalf.

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