The amendment form must be used by the lead Principal Investigator (PI) when submitting an amendment for a clinical trial or health/medical research project approved by the CALHN Human Research Ethics Committee.
Amendment submissions incorporate both CALHN ethics and CALHN governance review. Where an external site(s) is participating, the site PI’s must also report amendments to their institution via their local Research Governance Office.
Please note: Where CALHN is not the lead HREC, any external documents submiited to the lead HREC and their corresponding approvals from lead HREC are required for governance review by CALHN. Governance submissions using CALHN templates will not be accepted.
To access the CALHN Research Amendment Request Form click here.
For inquiries regarding amendments to studies, safety, protocol deviations and breaches, please contact CALHN Research Services at 08 7117 2223 or via email at Health.CALHNResearchMonitoring@sa.gov.au.