Post Approval - Updated Reporting Requirements and Information
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The Royal Melbourne Hospital is required to monitor all approved research until the completion of the project
In accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007) the RMH is required to monitor all approved research until completion and this can only occur through regular communication and reporting to the HREC and Office for Research.
This is where researchers provide information to the HREC in a timely manner as the requirement to report arises, such as serious adverse events (SAEs) and other safety information, requests for amendment of approved protocol/documents, other correspondence.
During the conduct of a research project, changes to the protocol may be proposed, or unintentional changes, deviations or violations may be discovered. Changes to the HREC-approved protocol, planned or otherwise, are governed by national regulations and Institutional policies and procedures.
In accordance with the National Statement Chapter 5.5.3, researchers also have a significant responsibility to monitor their research activity and must submit the following to the HREC, in relation to a given project:
This is where the HREC requests information from researchers about a project, such as annual project reports (or more frequent if required), final reports, safety reports. Two new forms for HREC initiated monitoring have been implemented: Annual Site Audit Reports and Annual Safety Reports. See below for further information.
There are three reporting requirements:
This is where the Office for Research requests further information about research staff or approved research projects, including auditing of research projects.