Any changes to a research project that affect site authorisation must be submitted as a post authorisation notification (PAN) to the Metro North Research Governance Office for review.
This includes HREC amendments that also impact the site activities or changes to the protocol or participant information sheet. HREC amendment approval is required before authorisation of a PAN can be granted.
Changes to associate investigators that do not impact the study or transfer of data do not require governance approval. These changes do not require a PAN, and can be managed via the study delegation log.
Submit a PAN
At a minimum, PANs should include:
PANs are submitted via ERM. Refer to the ERM User Guide and FAQs documents to assist with accessing and using ERM.
Cover letter
A cover letter detailing the PAN and the rationale for change is a mandatory requirement for all PANs. The cover letter must provide a summary of the HREC amendment approvals, including all documents approved by the HREC. Depending on the types of changes outlined in the PAN, the cover letter must address any site authorisation implications such as budget and resource implications, impacted supporting departments, new external collaborators that require contracts, and approval of site-specific PICFs or other supporting documents.
Study Documents
All study documents must have version control identifiers in the footer i.e. version numbers, dates and page numbers. The version control identifiers on the document must match the study document list in the cover letter.
PANs where Metro North is the reviewing HREC
Where Metro North is the reviewing HREC, copies of approved documents do not need to be attached to the PAN.
Any site-specific documents created from the approved master documents should be submitted for review.
The full list of approved documents must be provided in the cover letter.
PANs where Metro North is not the reviewing HREC
Where Metro North is not the reviewing HREC, copies of the approved documents must be uploaded with the PAN.
- For changes to the Principal Investigator, a Curriculum Vitae/Resume must be provided
- For protocol amendments, the track changed version and clean version approved by the HREC must be provided.
- For changes to the PICF and other supporting documents, the track changed version and clean version approved by the HREC must be uploaded.
Site amendments
Any HREC amendments that impact site activities, or changes to the protocol or PICF must also be submitted to the research governance office via ERM as a post-authorisation notification.