Monitoring Report Requirement Change
Effective October 1, 2017, written reports of study monitors will require central filing with the Post Approval Review (PAR) program of the HRPP and no longer require mandatory submission to the IRB. This change is being carried out in light of the full migration of all clinical research protocols to ETHOS and aligns with planned global changes described in the Advancing Human Research Protections Final Monitoring Report.
Investigators are required to submit promptly reportable events to the IRB within five business days of discovery of the event. Occasionally, such events are identified during clinical monitoring and, as such, must be reported to the IRB accordingly.
To submit monitoring reports to PAR, complete this form. You'll be asked to attach the monitoring report to the form.