Post - Authorisation Management
The Principal Investigator at a site is responsible for notifying the Research Governance Officer (RGO) of all amendments and processing all milestones within REGIS. All amendments and contract changes are to be submitted via REGIS for RGO review.
Site General Amendment
Please submit a site general amendment in REGIS for:
- changes to the study protocol, including the conduct and / or design of the study
- changes to any other study documentation (e.g. consent and recruitment material, study tools)
- site specific versions of approved masters need to be uploaded for all amended patient facing documents
If approving HREC is internal to NSW, the HREC approval and approved documents are not required to be uploaded as they will flow through the REGIS system, you will still need to upload all other site specific documents
If approving HREC is external to NSW, the HREC approval and all approved documents need to be uploaded to REGIS, along with all other site specific documents.
Changes to personnel
Please submit a site changes to personnel amendment for:
- changing site investigators
- changing administration contact
- for HREC external to NSW - change to CPI/PI and upload HREC approval and CV
Please note: HREC internal to NSW for Change to CPI / PI - the NSW HREC automatically updates REGIS, and no additional site amendment is required
Please ensure a current Good Clnical Practice Certificate (GCP) is provided if you are adding internal OR external team members for study type: clinical trial
Please ensure you nominate all external researchers that are coming on site or that will be accessing identifiable patient data within the Study Team and review HNE Site and eMR access for external researchers
Please submit all contract amendments via site amendment contract changes in REGIS.
Please ensure both CRG and HNE PI have signed the contract amendment prior to submission.
Electronic Signatures - Click here for further information
Please contact HNELHD-ResearchOffice@health.nsw.gov.au with any queries.
Request for an extension of HREC
Please submit site amendment request for an extension of HREC only if approving HREC is external to NSW
- Expiry date is automatically updated once request has been approved by ethics
Please note: HREC internal to NSW for extension of HREC - the NSW HREC automatically updates expiry date in REGIS, and no additional site amendment is required
- REGIS quick reference guide - Site Amendment - Completing & Submitting
Progress / final reports
Please use the progress/final report Milestone in REGIS only for projects with approving HRECs external to NSW, and provide the following;
- Copy of the progress/final report
- HREC approval/acknowledgement letter.
If the milestone is not appearing in REGIS, please contact the HNE Research Office via HNELHD-ResearchOffice@health.nsw.gov.au and request a milestone report be created to allow for submission of the report.
Please note: HREC internal to NSW for Progress / Final reports are reviewed and approved by the HREC, once approved NSW HREC automatically shares the reports and HREC approval in REGIS, and no additional site milestone submission is required. The HNE Research Office will only contact you if there have any queries or concerns.
Updated Certificate of Currency (CoC)
Please upload updated evidence of insurance via Milestone in REGIS for RGO acknowledgment.
If your milestone is not appearing in REGIS, please contact the HNE Research Office via HNELHD-ResearchOffice@health.nsw.gov.au and request a milestone report be created to allow for submission of the evidence of insurance/s.
- HREC approval is NOT required for this milestone submission
REGIS quick reference guide - Submitting a Governance Milestone