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Mar 22, 2021 9:50 AM - Mar 24, 2021 2:30 PM

(Eastern Standard Time)

Medical Affairs and Scientific Communications Forum

On Demand 2 Track 2: Writing CSRs and Protocols for Potential Public Release

Session Chair(s)

Andrea Tuttle Meyers

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


    Andrea Tuttle Meyers

    Bringing Clinical Trial Conduct and Reporting to the Dinner Table

    Andrea Tuttle Meyers

    Syneos Health, United States

    Senior Vice President, Clinical Operations

    Pooja  Phogat, PhD

    Regulations Governing Public Disclosure of Clinical Trial Documents

    Pooja Phogat, PhD

    Krystelis Ltd., India

    Co-founder and Co-CEO

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