Review process

Overview of the review process for clinical trials and clinical research studies

review process revised
  1. Meeting with Research Governance, Ethics & Assurance (RGEA) Team (new researchers only)
  2. Researcher submits draft protocol and risk assessment if available the PIS, ICF, IB/SmPC
  3. Agree review timelines
  4. RGEA reviews protocol and provides comments
  5. Researcher returns amended protocol
  6. Final draft protocol agreed
  7. Researcher submits complete set of draft documents to RGEA
  8. RGEA checks for completeness
  9. Agree review timelines
  10. RGEA reviews documents and provides comments
  11. Researcher returns amended documents
  12. RGEA assesses amended documents
  13. RGEA final signatory review
  14. Researcher finalises documents
  15. Approval of sponsorship
  16. Submit application to NHS REC and HRA (if required) and MHRA (CTIMPs only). Initiate NHS trust or other host organisation approvals
  17. Amended documents (at NHS REC/HRA/MHRA request) sent to RGEA
  1. Researcher submits complete set of draft documents to RGEA
  2. RGEA checks for completeness
  3. Agree review timelines
  4. RGEA reviews documents and provides comments
  5. Researcher returns amended documents
  6. RGEA assesses amended documents
  7. RGEA final signatory review
  8. Researcher finalises documents
  9. Approval of sponsorship
  10. Submit application to MS IDREC or NHS REC and HRA (if required) and MHRA (CTIMPs only). Initiate NHS trust or other host organisation approvals. 
  11. Amended documents (at MS IDREC/NHS REC/HRA/MHRA request) sent to RGEA

Contacts

RGEA TEAM  

Related links