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Annual and final reports

  • Annual reports 

    The Principal Investigator (PI) must submit annual progress reports. They should do this in Ethics Review Manager (ERM) and include their signature. They do not need to provide hard copies.

    The requirements for annual reporting depend on the type of approval your study has.

    For single-site research approved by the RCH HREC

    • An annual report is due on the annual anniversary of the HREC approval date. 
    • A Project Progress Report should be completed in ERM.
    • Once we have reviewed the report, we will email formal acknowledgement to the PI.

    For multi-site research approved by the RCH HREC

    • An annual report is due on the annual anniversary of the HREC approval date.
    • It is the Coordinating Principal Investigator (CPI) responsibility to ensure that progress from all sites covered by the ethical approval is provided. Thus the CPI should request relevant information from each site and collate this information into the Project Progress Report.  
    • A Project Progress Report must be completed and submitted in ERM by the CPI. 
    • Once the Project Progress Report has been reviewed, a formal acknowledgement will be emailed to the CPI.
    • The CPI should provide a copy of the Project Progress Report and HREC acknowledgement to the participating sites.
    • The Principal Investigator (PI) at each accepting site should then submit their Site Progress Report to their local Research Governance Officer; along with a copy of the Project Progress Report and HREC acknowledgement (for RGO information).
    • If RCH is also a participating site the RCH PI should also complete the Site Progress Report as noted above.
    • Once the Site Progress Report has been reviewed from a governance perspective, a formal acknowledgement will be emailed to the PI.
    • If a participating site is in a jurisdiction that does not use ERM the PI should submit the documentation as required by their Research Office.

    For multi-site research approved by an external HREC - governance only at RCH

    • The local RCH Principal Investigator (PI) must provide the Coordinating Principal Investigator (CPI) with relevant site information so the CPI can submit a Project Progress Report (or their equivalent report if not using ERM) to the external reviewing HREC.
    • Once the Project Progress Report has been acknowledged by the HREC, the RCH PI must complete and submit a Site Progress Report in ERM; along with a copy of the Project Progress Report and HREC acknowledgement (for RGO information) obtained from the CPI.
    • Once the Site Progress Report has been reviewed from a governance perspective, a formal acknowledgement will be emailed to the PI.

    Final reports, including site closure reports

    You should make all reports in Ethics Review Manager (ERM) and include the PI's signature. You do not need to provide hard copies.

    When a study is complete, or an individual site in a multi-site study has closed, the following reporting is to be followed.

    For single-site research approved by the RCH HREC

    • A Project Final Report must be submitted to the HREC (via ERM) when a study has been completed (or abandoned). 
    • Once the report has been reviewed, a formal acknowledgement will be emailed to the Principal Investigator (PI).

    For multi-site research approved by the RCH HREC - all sites closing

    • It is the Coordinating Principal Investigator (CPI) responsibility to ensure that information from all sites covered by the ethical approval is provided. Thus the CPI should request and collate this information into the Project Final Report.
    • Project Final Report must be submitted by the CPI to the HREC (via ERM) when a study has been completed (or abandoned).
    • Once the Project Final Report has been reviewed, a formal acknowledgement will be emailed to the CPI.
    • The CPI should provide a copy of the Project Final Report and HREC acknowledgement to the participating sites. This does not apply to the RCH participating site as we have access to the Final Report documentation.

    For multi-site research approved by the RCH HREC - individual sites closing only

    • The RCH Coordinating Principal Investigator (CPI) should request final study information from the closing site. The CPI is then to submit a Site Closure Report (via ERM) to the RCH HREC.
    • Once the Site Closure Report has been reviewed, a formal acknowledgement will be emailed to the CPI.
    • The CPI should provide a copy of the Site Closure Report and HREC acknowledgement to the closing site.
    • The Principal Investigator (PI) at the closing site should then submit a Site Notification (via ERM) to their local Research Governance Officer; along with a copy of the Site Closure Report and HREC acknowledgement (for RGO information).
    • There is no Site Final Report available in ERM for a SSA/governance only site, therefore the Site Notification form is used.
    • If an accepting site is in a jurisdiction that does not use ERM the PI should submit the documentation as required by their Research Office.

    For multi-site research approved by an external HREC - governance only at RCH

    • The local RCH Principal Investigator (PI) must provide the Coordinating Principal Investigator (CPI) with information to allow them to complete either a Site Closure Report or a Project Final Report for the external reviewing HREC as relevant. See below for which report type.
    • A Site Closure Report will be completed by the CPI if an individual site is closed, and the study continues at other sites.
    • A Project Final Report will be completed by the CPI if the study has been completed at all sites.
    • Once the Project Final Report or Site Closure Report has been reviewed by the external HREC, a formal acknowledgement will be emailed to the CPI.
    • The RCH PI should then submit a Site Notification (via ERM) to the RCH Research Governance Officer; along with a copy of the Site Closure Report or Project Final Report and the external HREC acknowledgement.
    • Once the Site Notification has been reviewed from a governance perspective, a formal acknowledgement will be emailed to the PI.

    Final letter to participants

    At the end of your study, you should send participants a final letter. These final letter guidelines tell you how to write and submit your final letter.

    Ongoing approval

    The RCH HREC cannot issue fixed ethical approval periods - this is line with Victorian standards. Instead, approval is conditional on the submission of annual progress reports. For this reason, renewals are NOT required. Approval is ongoing for the life of the project and will only end if:

    • an annual report has not been submitted within six months of the due date
    • a final report is submitted, or
    • approval is withdrawn or suspended by the HREC