Post Approval - Updated Reporting Requirements and Information
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RMH, the ethics committee and investigators must ensure that the research continues to conform to approved ethical standards, and in accordance with the Melbourne Health Research Policy.
I have Ethics and Governance approval, what now?
- Ensure that every participant enrolled in a research project is registered on the iPM patient database as a research participant at the time they are first enrolled or consented. For more information on how to register patients.
- Ensure that participants are registered and have a UR number. All study participants must be registered with Health Information Services (HIS) and issued with a Melbourne Health UR number. This includes healthy volunteers participating in research who do not have an existing medical record. Visit the HIS webpage for more information.
- Notify the Office for Research of the actual start date of the project at Melbourne Health
You are also required to submit or notify the Office for Research of the following:
- Amendments where:
- There have been changes to the indemnity, insurance arrangements or Clinical Trial Research Agreement for the project
- You are unable to continue as Principal Investigator or any other change in research personnel involved in the projects
- Adverse Events involving patients of Melbourne Health.
- Protocol Deviation and Violation
- Updated insurance certificates - submit to: InsuranceCertificates@mh.org.au - include the project number in the subject line
- Progress Report every 12 months
- A Final Report upon completion of the project
- Correspondence which may include:
- Unforeseen events
- Any matters not covered elsewhere which may impact on the conduct of the project at Melbourne Health.
- Amendments to the project approved by another Ethics Committee
For all CTN Clinical Trials
If your study is a CTN clinical trial, you must also provide the following to the Office for Research:
- The confirmation of the date of the site initiation visit. If your research project is a commercially sponsored clinical trial, email the Office for Research as soon as the site initiation visit has occurred, and provide confirmation of the date of this visit (and reference the corresponding local HREC project number).
- A PDF copy of the CTN submitted to the TGA supplied by your sponsor.
- A copy of the TGA acknowledgement letter in respect of the CTN notification.
Post approval monitoring
RMH is required to monitor all approved research until completion in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007) 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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