Guidance to Principle Investigators for submissions of documents
Submission of proposals for Continuing Review
ERC approval is provided to a project only for a limited time period, usually for a period of one year. In order to renew approval the WHO TO is required to submit the following documents:
- A memo to the ERC for a renewal
- A Coversheet for Continuing Review completed by the WHO Technical Officer
- Continuing Review form to be completed by the P.I.
- Progress Report of the project for the past recruiting period, highlighting the activities of the project and any deviation from the approved activities including any change to the proposal or to the informed consent documents.
- An approval from the technical unit or the peer review group. (Some departments submit the progress report of the project to the peer reviewers or a technical group or the Steering Committee for their approval before releasing funds for another year. ERC recommends this as a Best Practice and encourages technical teams to adopt this process.)
- Report from a DSMB/ DSMC, if it was established for the monitoring of the study.
- Copies of any amended or modified documents or new documents.