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Post-approval responsibilities

Researcher looking at the reader

After your study has been given ethics approval, there are a number of responsibilities that you will need to maintain:

Amendments

Please submit an amendment if you want to change the study design, study team or request a time extension.

Worktribe amendments

Amendments for studies completed and approved via Worktribe, go to your approved application in Worktribe. In addition, please complete the Notice of Amendment (Worktribe) and upload to Worktribe with your updated documentation (tracked changes).

Please do not use the 'extend' button in Worktribe for requesting a time extension. For this please follow the process above for requesting this in an amendment.

Pre Worktribe amendments

Amendments for studies approved pre Worktribe the Notice of study amendment [Word] form should be used. Once completed, this form (along with any updated documentation, tracked changes) should be submitted to the Ethics and Research Governance Coordinator

Annual Progress Report

This is a condition of receiving ethics approval. If you do not submit an Annual Progress Report, your study will be assumed to be closed, and ethics approval will be stopped.

Pre Worktribe

The Annual progress report [Word] must be submitted to the Ethics and Research Governance Coordinator within 30 days of the anniversary of a project being granted ethics approval. If a study is completed within a year of first obtaining ethical approval, an End of Study Notification must be submitted instead.

Worktribe

Annual progress reports for studies completed and approved via Worktribe, notify the Ethics and Research Governance Coordinator as above. If you receive an annual report request via Worktribe, then please complete the relevant online forms for this instead.

End of Study Notification

You must notify the RGI team when your study has ended; within 90 days of the termination of your study or when the practical research activity ended. Practical research in this context means, for example, the end of participant related procedures (last participant last visit) but not data analysis.

This must be supported by an end of study summary report submitted within 12 months of the notification. You must also notify the committee within 15 days if you have terminated the study early.

Pre Worktribe

Once completed, the forms below should be submitted to the Ethics and Research Governance Coordinator.

Worktribe

End of study reports for studies completed and approved via Worktribe, notify the Ethics and Research Governance Coordinator as above. If you receive an end of study notification request via Worktribe, then please complete the relevant online forms for this instead.