The safety reporting process to the RPAH RGO is as follows:
• SUSAR reporting Not required
• SAE occurring within the RPAH zone, submit:
1. SAE notification to HREC within 72 hours
2. Letter to RGO stating that an SAE has been submitted to HREC and that RGO will be notified of the HREC outcome when it is available
• SAE occurring at site outside the RPAH zone, do not submit to RGO unless:
- The SAE is considered possibly related, probably related or definitely related to study conduct
- The SAE had an effect on the conduct of the study (requiring any or all of the following):
- Protocol changes
- Investigator Brochure changes
- Participant Information Sheet changes
A Protocol Deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator’s control and that has not been approved by the HREC.
A Protocol Violation is any change, divergence, or departure from the study design or procedures of a research protocol that affects the participant's rights, safety, or well-being and/or the completeness, accuracy and reliability of the study data.
• Minor protocol deviations: If these do not carry significant ethical / administrative implications or consequences they do not need to be reported to the HREC.
o However, please record all such deviations in the study file and report them to the sponsor.
• Major deviations and protocol violations: If these pose a risk to patient safety, or have ethical or significant administrative implications they must be reported to the HREC and the Sponsor as soon as possible.
When SLHD (RPAH) is the lead HREC:
• submit cover letter stating that HREC approval has been obtained and date of HREC approval
When SLHD (RPAH) is NOT lead HREC:
• submit copy of annual report and copy of HREC approval letter or email of HREC acknowledgement