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 termination or suspension of a research project has occurred along with the reason for the termination or suspension.
- When there is a significant divergence between actual progress or outcomes and the project’s original objectives, hypotheses or expectations. This only is required if there is no amendment that will be submitted to address the divergence.
- There have been any changes to a project, having significant implications for project participants or the conduct of the trial. This only is required if there is no amendment that will 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 [email protected] including the Peter Mac Project No. and the term ‘Noting Item’ in the subject line of the email.
These items will be acknowledged.