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DoubleTree Bethesdan

Sep 18, 2019 8:30 AM - Sep 18, 2019 12:00 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Short Course 1: Clinical Trial Disclosure 101


Short Course requires Pre-Registration and is an additional fee.

This short course presents ‘the big picture’ of clinical trial disclosure for those new to this growing profession or experienced professionals who may still be struggling to understand how all the pieces fit. We will offer an overview of study registration, posting of summary study results, sharing of participant-level data, lay summary results and public posting of study documents such as protocols, SAPs and clinical study reports. ‘Old’ regulations (US FDAAA and EU CTD) will be compared to updated regulations/policies (US Final Rule and EU CTR and Policy 0070), with a bit of time spent on the newly enacted Canadian regulation. We will also cover the influencers of clinical trial disclosure and the impact they have had and will continue to have on the public, WMA, WHO, ICMJE, MRCT, AllTrials, others. Let’s put all these pieces together.

Learning objectives

At the conclusion of this short course, participants should be able to:
  • Describe the full range of clinical trial disclosure activities and scope of colleagues who need to coordinate their activities
  • Analyze prior “old” regulations and updated regulations and describe differences
  • Identify different audiences who are influenced by disclosure activities and how best to communicate with them

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