Site Principle Investigator Responsibilities
The Site Principle Investigators' (PIs) responsibilities for reporting deviations and serious breaches to Sponsors (for all types of trials - commercially sponsored, collaborative research group or investigator-initiated trials (IITs)) should be described in the protocol and Manual of Procedures (MOP) or standard operating procedure (SOP).
The Site PIs' responsibilities for reporting serious breaches to their institution (via the research governance office) should be described in SOPs owned by their institution. Furthermore, the institution may also require site staff to record important non-compliance with the protocol or Good Clinical Practice (GCP) on a centralised quality system log.
The Site PI is not responsible for reporting deviations or serious breaches to the reviewing Human Research Ethics Committee (HREC), this is the responsibility of the Sponsor-Investigator.
The Sponsor-Investigator should provide sites with a mechanism for recording and reporting non-compliance, including capturing deviations in the Case Report Form (CRF) and a deviation/non-compliance report form.
The Site Principal Investigator responsibilities include:
- Ensure all members of the trial team know how to identify a serious breach and escalate them to both the Sponsor-Investigator for assessment and the local research governance office.
- Capture all deviations of the protocol (and associated procedures) and GCP that are linked to a participant in the CRF.
- Identify when a deviation potentially meets the definition of a serious breach. At this stage in the assessment, a potential serious breach is termed a 'suspected breach'.
- Report serious breaches to stakeholders.
- Work with the institution/Sponsor-Investigator, to implement any corrective and preventative actions (CAPAs). Also consider whether the issue could impact other patients or trials.
- Management of essential documents relating to deviations and serious breaches in the Investigator Site File.
Reporting to stakeholders and timeframes
- Sponsor-Investigator should be notified of suspected breaches within 72 hours of becoming aware of the suspected breach.
~ Serious breaches are reported using the Sponsor-Investigator’s non-compliance report form template and submission process, eg emailing the Sponsor-Investigator’s nominated account or uploading via a trial portal.
~ No participant identifiable information should be included in the report.
- The local Research Governance Office should be notified of serious breaches (confirmed by Sponsor-Investigator) within 72 hours of being notified of the serious breach by the Sponsor-Investigator. Forward the copy of the Serious Breach Report from the Sponsor-Investigator to the Research Governance Office using the locally-approved process.