The governance review is completed when all the relevant permissions and approvals have been obtained and reviewed by the relevant parties.
Occasionally during review of the project, regulatory bodies may require clarification or give approval subject to certain amendments. Following this period of iteration, or in some cases resubmission, there should come a time when all necessary approvals and permissions are obtained. The governance timeline can be suspended if all internal checks are complete, but an external approval is outstanding.
Clear evidence of the documents submitted to the approval bodies (the submission package) and the documents that were approved (approval letters referencing the submission package) need to be retained in the Trial Master File. This will allow auditors / inspectors to confirm that all legal and good practice requirements have been followed.
Approve trial
Once the JRCO is satisfied that all approvals are in place, it can approve the trial.
Resources
| Type | Where to find |
|---|---|
| Key contacts | JRCO |
| Useful links | NIHR Clinical Trials Toolkit - permissions and approvals |
| NIHR benchmark | Within NIHR 70-day benchmark (Day 0-30) |
| Process map links | This activity occurs in the governance stage: > Imperial College London as sponsor > Imperial College Hospital NHS Trust as sponsor > Commercial organisation as sponsor > Non-commercial organisation as sponsor |