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On Demand 2 Track 2: Writing CSRs and Protocols for Potential Public Release
Session Chair(s)
Andrea Tuttle Meyers
Senior Vice President, Clinical Operations
Syneos Health, United States
Due to the impact of the current global pandemic, clinical trial transparency has become more important than ever. Prior to the COVID-19 pandemic, health authorities were already focused on clinical trial disclosure and transparency initiatives; however, with the pandemic the public-at-large and layperson have become familiar with clinical trial vernacular and are demanding access to clinical trial information. In order to encourage trial participation and successful launch of approved products, access to and transparency in clinical trial documents, particularly the Protocol and Clinical Study Report, have become a critical components in the global public health response. This session will explore the how, when, why, what, and where of disclosing study protocols and trial results to the general public as well as the HRA “Make it Public” initiative and the FDA penalties for not following the regulation.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand disclosure regulations and requirements as they relate to clinical trial documents
- Know when and how to submit study protocols and trial results for public consumption
- How to prepare the information to be digested by the average layperson
Speaker(s)
Bringing Clinical Trial Conduct and Reporting to the Dinner Table
Andrea Tuttle Meyers
Syneos Health, United States
Senior Vice President, Clinical Operations
Regulations Governing Public Disclosure of Clinical Trial Documents
Pooja Phogat, PhD
Krystelis Ltd., India
Co-founder and Co-CEO
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