The RETP presents a workshop on

NHMRC Safety Reporting and Three Supplementary Guidance

Day & Date:

Friday, February 22, 2019

Time:

09:00 – 11:00

0Weeks0Days0Hours

Workshop Format

Face-to-Face attendance where you will be engaged in discussion and a question and answer format).

Cost

$200 per person (*please note that some institutions are hosting and funding this w/shop for their staff).

Facilitator

The facilitator is Tanya Symonds was a consultant technical writer for the NHMRC Safety Reporting & 2018 Three Supplementary Guides:

  1. NHMRC Data Safety monitoring Board (2018)
  2. Reporting of Serious Breaches of Good Clinical Practice or the Protocol for Trials Involving Therapeutic goods (2018)
  3. Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods (2018)

Topic overview

The NHMRC published new safety monitoring and reporting guidelines for clinical trials in 2016 that substantially changed requirements in Australia. In 2018, the NHMRC published three more guidance documents: Reporting of Serious Breaches of GCP and the Protocol. Data Safety Monitoring Boards and Risk Based Management and Monitoring of Clinical Trials. These guidelines impact on a wide range of clinical trial stakeholders – Site staff, sponsors, ethics committees and research offices.

The session will summarise the key content of all four documents with particular focus on the Safety Monitoring and Reporting and Serious Breach Guidelines as these have raised a number of change management issues. The key aim of the session is to help delegates better understand how these Guidelines should be operationalised at site or sponsor level.

Who should attend?

Anyone with an interest in finding out how the four sets of NHMRC Clinical Trial Guidance have been (or should be) operationalised.  In addition, those who want to better understand their particular responsibilities for either safety monitoring and reporting or serious breach reporting for clinical trials, will find this session useful.

Location

Harry Perkins Institute for Medical Research (north) at the QEII Medical Centre, Nedlands

Room (TBC)

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