In March of 2020, the U.S. Food and Drug Administration (FDA) released the guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” This guidance addresses the challenges that have presented as a result of the current global pandemic, which include difficulties in meeting protocol-specific procedures, administration or use of an investigational product or adhering to protocol-mandated visits, and access to laboratory/diagnostic testing. Many roadblocks have resulted from these challenges, not the least of which is clinical study data tracking and accuracy.
NAMSA invites you to join us for this upcoming webinar, presented by leading clinical trial data management experts, to learn best practices and strategies regarding how to properly manage clinical data throughout the COVID-19 Pandemic. Included will be a deep dive into database design and/or changes and how streamlining collection and maintaining consistent data can assist with reporting and analyzing throughout a study.
Participants of this webinar will leave with a better understanding of:
- Study requirements as they relate to the COVID-19 Pandemic
- Study team collaboration and its importance when identifying changes to data collection throughout the pandemic
- Various options that can be utilized to capture COVID-19 information with existing Case Report Forms (CRFs) and/or changes to CRFs
- Documenting study decisions made to address COVID-19