Prior to Start Up and Approval

Operational Review (Capacity and Capability)

The Research Facilitation Group review is a standard process for all PI’s to complete for all new research studies that involve Trust patients, facilities, equipment, data or staff bar no objection studies. When registering your study with the R&D Governance Team you will be advised if your study needs to be reviewed by this process. Please use your RRK reference in any correspondence.

A RFG PI questionnaire must be completed and submitted along with a data set that will facilitate operational capacity and capability review. The Principal Investigator of the Study is responsible for completing the RFG PI questionnaire.

Please follow link to PI C(RFG) Questionnaire

Please follow link to the R & D Study Stage Map

If you have access to R & D Manager, please ensure documents are uploaded before a slot is requested.  You are able to submit any manuals, grant applications & protocols at the end of the RFG questionnaire before you hit submit. If you do not have access please email RFG@uhb.nhs.uk with your RRK reference and request that it be uploaded on your behalf.

Please ensure you provide/upload the following information:

  •  REC/ HRA Approval documents
  • Latest Protocol
  • Blank patient information (PIS) + consent form
  • Completed PI questionnaire
  • Funding details i.e. copy of grant application/ award letter if Lead Site and/or Statement of Activities/ Events if participating
  • If Pharmacy involvement; IB; Material Safety Data Sheet or Pharmacy Review Sheet Sample IMP Labels
  • Manuals (Lab, Pharmacy, Imaging)

 

If particular information is not available or not applicable please detail this in your e-mail.

 

Research studies may be tabled for remote review and approval however this is dependent on the:

  • Complexity of the study
  • if speciality has an internal research facilitation infrastructure (with terms of reference) and can support the study set up and delivery (e.g. speciality has research nurses with capacity)
  • if the study has been internally peer reviewed and approved (i.e. CRF Scientific Advisory Committee (SAC) or Internal Research Speciality Group).
  • There are no implications to the following service departments ie labs/imaging/pharmacy/informatics/therapy services /funding/research delivery team

Depending on the complexity of your study it will either be remotely reviewed and approved or a face to face presentation will be requested. A review slot will be confirmed on receipt of this completed questionnaire and receipt of the minimum document set.

Please use this e-mail address when sending any additional queries or documentation to the team:

RFG@uhb.nhs.uk            For non-cancer research studies

CRFG@uhb.nhs.uk         For cancer research studies

This review process works in parallel to the Governance Trust approval and Contracts process.  RFG Approval is required as part of that review process. Reviews can be turned around quickly if all information is provided and necessary service department reviews have taken place. Principal Investigators and the Lead Research Nurses will be notified of RFG Approval via email.

If you have any questions please email RFG@uhb.nhs.uk