Only protocol deviation/violations that affect patient safety must be reported to the Ethics Committee.
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.
A memo or Protocol Deviation or Violation Report form addressed to the Ethics Committee should include an explanation of why the deviation/violation occurred and what steps will be taken to prevent re-occurrence. The memo or report form should include the following
- Project number
- Name of the Coordinating Principal Investigator or Principal Investigator
- Name of the Study Coordinator and/or Contact Person
- Signature of the Coordinating Principal Investigator or Principal Investigator
Note: Please do not include any participant identifying information.
Email your submission to [email protected] including the Peter Mac Project No. and the term ‘Protocol Deviation/Violation’ in the subject line of the email.
These items will be acknowledged.
NOTE: Protocol deviations/violations that do not affect patient safety are not required by the Ethics Committee.