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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.

Amendments

Amendments cannot be reviewed by the RGO without evidence of relevant HREC approval, with the exception of contract and local team personnel changes as per the below.

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

Contract Changes

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.

Helpful Resources:

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

Useful documents

Milestones

Research Governance Officers maintain an oversight of authorised research projects through review of milestones submitted by the Principal Investigator, including any recommendations made by HREC following the review of progress/final reports.

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

Useful Documents

REGIS quick reference guide  -  Submitting a Governance Milestone