Course Outline: In 2016, the NHMRC published the 'Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods' guidance, which changed safety reporting requirements for all stakeholders and rationalised the type and number of reports sent to Human Research Ethics Committees (HRECs). Similarly, in 2018, the NHMRC published the 'Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods' guidance, which changed the requirements for reporting non-compliance to the HREC. Both guidance documents are complex and therefore challenging to interpret. This session, delivered by the author, aims to clarify their requirements.
Price: $800 + GST per session for up to 20 attendees
Mode of delivery: Live, interactive Zoom session
Duration: 1 hour including a question-and-answer session
Learning Objectives
NHMRC Safety Monitoring and Reporting Guidance
• Understand the rationale for the update to Australia’s safety reporting requirements for therapeutic goods trials
• Understand how to apply parallel requirements to other interventional research
• Be aware of the terminology associated with safety reporting
• Be able to delineate the roles and responsibilities of the sponsor, trial sites and ethics committee
NHMRC Serious Breach Guidance
• Understand the rationale for the publication of the NHMRC Guidelines
• Understand the terminology including the difference between a deviation, violation, and serious breach
• Be able to delineate the roles and responsibilities of the sponsor, trial sites and ethics committee
Certification: Attendees will be able to download a certificate of attendance following course completion.
