Resubmission of a clinical trial
Following are the site governance requirements for clinical trials coming to the end of their ethical approval and which are re-submitted for on-going ethics approval:
• When you submit the project to the HREC please write a letter to the site Research Governance Officer (RGO) to explain that you are re-submitting the ethics documentation for on-going approval
• When you receive the HREC approval letter please send a copy to the RGO and include:
- (If applicable) the previous and new local site numbers (for RPAH they begin with an “X”) to ensure that the documentation history is retained
- Updated Participant Information and Consent Forms ensuring that the site version number follows on from the previously allocated site version number. That is, if the last site version was Version 4 then the site version for the new local number will be Version 5.
• Inform the RGO(s) of:
- any change to site personnel
- any change to the involvement of supporting Departments.
- updated Certificates of Insurance
- CTRA Amendments