For an overview of the commercial, non-commercial, CRF run studies, Papworth Sponsored, and External CRF uses 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. These meetings are designed to assess feasibility and whether the Trust may have the capacity and capability to conduct the study. The committee will conduct a risk assessment of the study and review patient safety, operational and governance issues including contracts, indemnity, resources and finances, where upon it will be agreed whether the study can proceed through to the next stage of our Governance process, and eventually through to study set up
The PI (or their chosen representative) is also required to attend to present their study and answer any queries that may arise during the meeting. This is to avoid having to attend more than once, and helps to reduce potential delays during the setup of the study
In addition to this, proposed Royal Papworth sponsored studies are discussed at RGPAS meetings, where the decision will be made as to whether or not the Trust is able to sponsor 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.
Minimum documents required for Trust Confirmation of Capacity and Capability for non-Papworth sponsored studies at Royal Papworth Hospital
Please note: these documents are not all required to be submitted simultaneously. Due to the processes by which studies are approved, they will be requested at different intervals appropriate to your study and its progression.
Items required to initially assess feasibility:
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Research Ethics Committee (REC) letter of favourable opinion |
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Health Research Authority (HRA) letter of favourable opinion as well as confirmation from relevant regulatory bodies as applicable |
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MHRA letter of no objection (for medicinal safety and efficacy studies) |
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MHRA letter of no objection (for studies of medical devices which are unlicensed or being used in an unlicensed application) |
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All REC/HRA approved study documentation, i.e. protocol, patient information sheet, patient consent form |
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IRAS application form (for non-CTIMP studies) or CWOW form / Project Information Form (for CTIMP studies) |
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Draft budget |
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Draft site agreement / draft OID (if using as contract) |
Minimum requirements to complete site set up:
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Copies of the above documents, if recently updated or not previously sent. |
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Most recent version of the Local Information Pack (requested post RGPAS meeting) |
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Copies of approval letters from other regulatory bodies, if applicable e.g., ARSAC, CAG |
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Directorate Authorisations in are place |
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Support services have been informed of the study and the necessary registrations have been completed. |
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Risk Assessment completed |
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Evidence of GCP certification and CVs for all research staff, signed and dated in the past 3 years |
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Material Transfer Agreement in place (if required) |
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Service Level Agreement in place (if required) |
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Finalised version of the budget |
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Finalised version of the site agreement, with signatures |
We will also ensure studies are added to the asset register and study teams are informed of their obligations regarding the National Opt Out Scheme, should they be applicable.
All the above actions will be completed on your behalf by the study teams and / the Research Governance team.
To discuss the process for obtaining sponsorship agreement and Trust approval for your Royal Papworth sponsored study please contact the Clinical Project Managers.
Royal Papworth Sponsored Studies
To discuss the process for obtaining sponsorship agreement and Trust approval for your Royal Papworth sponsored study 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.
Minimum documents required to apply for study sponsorship at Royal Papworth Hospital
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Draft IRAS/CWOW (Combined Ways of Working) completed to state of completion prior to submission – must not be signed at this stage |
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Draft Protocol |
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Draft Patient Information Sheet (PIS) |
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Draft Informed Consent Form (ICF) |
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Contractual agreements with any external companies relevant to this study |
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Funding agreement |
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Evidence of independent peer review |
Which documents do you need to submit for Royal Papworth approval for Royal Papworth sponsored studies?
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1. Research Ethics Committee and HRA letters of favourable opinion |
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2. All Research Ethics Committee/HRA approved study documents e.g., protocol, patient information sheet, patient consent form |
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3. IRAS application form (xml and pdf formats of the final signed version) |
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4. MHRA letter of no objection (for medicinal safety and efficacy studies) |
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5. MHRA letter of no objection (for studies of medical devices which are unlicensed or being used in an unlicensed application) |
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6. Approval letters from other regulatory bodies, if applicable, e.g., ARSAC, CAGs |
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7. Agreed costings |
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8. Confirmation of funding to support the running of the study throughout |
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9. Contracts / SLAs with external organisations (final agreed and signed version), as applicable |
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10. CI's C.V, signed and dated within the past three years |
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11. CI's GCP certificate issued within past two years |
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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.