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.
The Research Governance Officer, Ethics Committee Secretariat must be notified of status/information updates for research projects at the Peter Mac site, as follows:
- Changes in Principal Investigator or Associate Investigators at Peter Mac.
- Termination or suspension of a research project has occurred along with the reason for the termination or suspension.
- Changes to a research project, having significant implications for use of Peter MacCallum Cancer Centre resources. This only is required if there is no amendment that will be submitted to address the implications.
- Updated Insurance Certificates of Currency for commercially sponsored trials only.
SUBMITTING YOUR PROJECT STATUS/INFORMATION UPDATES
- If Peter Mac Ethics Committee is not the reviewing HREC a copy of the notification must be submitted to the Research Governance Officer, Ethics Committee Secretariat. It is sufficient to submit a copy of the report as submitted to the external reviewing HREC or to submit in the format normally required for Peter Mac as reviewing HREC.
- If the external reviewing HREC requests any follow up or action to be taken please forward a copy of these communications to the Research Governance Officer, Ethics Committee Secretariat.
- If Peter Mac Ethics Committee is the reviewing HREC this requirement is satisfied by the submission to the Peter Mac Ethics Committee, if required. For information on the reporting procedures for Peter Mac as reviewing HREC, refer to SOP004 Monitoring Ongoing Research
These items will be acknowledged.
NOTE: If the reporting requirement is satisfied by submission to the Peter Mac Ethics Committee, the acknowledgement issued for the report also serves as acknowledgement by Research Governance.