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Consultation on a revised Position Statement on Safety Reporting and Monitoring in Clinical Trials Involving Therapeutic Goods

Closed on Friday, 27 May 2016, 11:59pm (AEDT). Submissions are no longer being accepted.

The National Health and Medical Research Council (NHMRC), with the assistance of a Working Committee of the Australian Health Ethics Committee (AHEC), has revised the 2009 AHEC Position Statement on Monitoring and reporting of safety for clinical trials involving therapeutic products.

NHMRC is now seeking public comment on the revised Position Statement.

The Position Statement clarifies the responsibilities of all parties in relation to reports of adverse events, including serious adverse events and suspected unexpected serious adverse reactions. The Position Statement outlines the minimum requirements regarding safety reporting and monitoring needed to conform to the National Statement on Ethical Conduct in Human Research (2007) (National Statement).

The intention of the revised Position Statement is to remove the existing duplication in reporting requirements between a Principal Investigator, a sponsor and the approving Human Research Ethics Committee (HREC), and to clarify reporting requirements so that the most appropriate body receives the necessary reports. Importantly, safeguards remain in place to ensure participant safety.

The revised Position Statement takes account of reforms to safety reporting in the European Union and United States and provides detailed guidance for trials involving investigational medicinal products and investigational medical devices. The revision of the Position Statement is part of a broader program of work to move towards a nationally consistent approach to the way clinical trials are conducted and overseen.

Comments on the revised Position Statement close at 11:59pm Friday 27 May 2016.

Consultation documents

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Consultation date

Please note the Timezone is AEDT.

Opening date: 
Wednesday, 27 April 2016 - 9:00am
Closing date: 
Friday, 27 May 2016 - 11:59pm
Please note that for some NHMRC consultations no extensions will be given. Where extensions are available you will need to contact the project officer using the contact details at the bottom of this page. However, in order for NHMRC to extend the date of a submission you will need to have created an account and started a submission.
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Page reviewed: 26 May, 2016