Project Status/Information Updates should be submitted by:
- MULTI-SITE ETHICAL REVIEW: Sponsor or Coordinating Principal Investigator (or delegate) on behalf of site or all sites
- SINGLE SITE ETHICAL REVIEW: Sponsor or Principal Investigator (or delegate) for Peter Mac site
If not submitted as a safety report, in accordance with SOP006 Safety Reporting, a project status update must be submitted in the following circumstances:
- When a research project is suspended, the reason for the termination or suspension has occurred
- When there is a significant divergence between actual progress or outcomes and the project’s original objectives, hypotheses, or expectations. This is only required if no amendment is to be submitted to address the divergence
- There have been changes to a project, having significant implications for project participants or the trial's conduct. This is only required if no amendment is to be submitted to address the implications
Submitting your project status/information updates
Progress status/information updates are usually in the form of a letter or memo addressed to the Ethics Committee and should include the following:
- Project number
- Name of the Coordinating Principal Investigator or Principal Investigator
- Name of the Study Coordinator and/or Contact Person
- Reason for notification and explanation of the impact on research participants
Note: Do not include any participant identifying information.
Email your submission to
These items will be acknowledged.