Post Approval - Updated Reporting Requirements and Information
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Melbourne Health 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) MH 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.
Researcher initiated monitoring
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:
- Reports of Adverse/Serious Adverse Events/Suspected Unexpected Serious Adverse Reactions - in accordance with the Melbourne Health Guidelines for Monitoring and Reporting of Safety in Clinical Trials Involving Therapeutic Products and Other Clinical Research and advise the HREC if the event has resulted in an amendment to the protocol and/or to the informed consent document.
- Protocol amendments, updates to Investigator Brochures or changes to informed consent documents - from time to time, amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors (such as pharmaceutical companies) and may also require a change to the informed consent process.
- Correspondence - notification of start of recruitment, project closed to accrual, protocol deviations or project suspended for a period of time, or any other matters that need to be reported to the HREC (including reason or discussion where appropriate).
HREC initiated monitoring
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:
- Annual progress report - each year whilst a project is in progress (including compliance with any conditions of approval and maintenance and security of records). Download the FAQ - Post Approval document for information regarding July amnesty; August reconciliation; and conditions for withdrawal of ethical approval.
- Final report - on completion, project termination or withdrawal (including a copy of the results, information sent to participants and any publications).
- Annual site audit report - an annual site audit report is to be submitted each year with the annual progress report for all projects with a Melbourne Health site whilst a project is in progress (including compliance with any conditions of approval and maintenance and security of records).
- Annual safety report - all clinical trials involving therapeutic goods required to be submitted each year with the annual progress report whilst a project is in progress (including compliance with any conditions of approval and maintenance and security of records)
- Amendments, adverse events, other relevant safety information or other matters which may impact the conduct of the project.
Office for Research initiated monitoring
This is where the Office for Research requests further information about research staff or approved research projects, including auditing of research projects.
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