Guidance to Principle Investigators for submissions of documents
Submission of response to the ERC review
- In a cover memo, please address your response to each of the queries in sections 1 and 2 of the ERC Review Summary POINT BY POINT.
- Submit a revised amended protocol incorporating all the requested amendments. All changes should be marked either in bold or highlighted or they should be in track changes
Upon approval from the ERC:
- Please submit a final protocol without track changes or highlighting. If the requested changes are only to the informed consent documents or the study instruments, then only these may be re-submitted.