Writing CSRs and Protocols for Potential Public Release
ON DEMAND | Live Q&A Wed, March 24, 11:20 - 11:40am EDT
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.
Session Chair & Speaker:
- Andrea Meyers, Senior Vice President, Medical Writing, Syneos Health
- Pooja Phogat, PhD, VP, Head of Development Operations, Kinapse, A Syneos Health Company, India