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Looking Beyond the Pandemic: Ensuring Data Integrity Post-COVID-19

Lessons Learned from a Virtual Town Hall held on May 22, 2020

The impact of COVID-19 has become clear on a more granular level as we continue conducting clinical trials in the midst of the pandemic. Importantly, trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever, and it’s imperative that industry keeps this top of mind.

Halloran’s 8th Virtual Town Hall held on May 22, 2020, convened a panel of clinical and statistical experts to provide insight on how sponsor companies should approach documentation, analysis, and reporting in the COVID-19 era. The discussion centered around COVID-19 impact assessments, mitigations, monitoring visits, and documenting protocol deviations appropriately to ensure data integrity. The following strategies and processes are currently being utilized by key players in the industry during the pandemic, and provide insight into how to best proceed in the future.

Assessing the Impact of COVID-19

Impact Mitigation

Utilizing Monitoring

Data Integrity

Amongst our panelists, the most prevalent data integrity challenge during COVID-19 has been missing data due to missed visits. As we continue to move to converted or modified visits, coordinators are dealing with the increased workload by contacting patients, collecting as much data as possible despite missed visits, and entering data as best they can into the EDC.  Sponsors need to ensure that data entry occurs in a manner that will provide useful, meaningful information in the future.

Capture Protocol Deviations Appropriately

Before, During, and After: Evaluating Site-By-Site Differences

When to Intervene

Though most areas of the United States are still in the throes of COVID-19, it’s time for sponsors

to begin looking beyond the pandemic, focusing attention on strategies for assessing the pandemic’s impact on data integrity, tactics for impact mitigation, and methods to ensure overall data integrity. Flexibility and forethought will be key as we aim to set our studies up with meaningful data for future success both during and after the pandemic.  There is a lot to be learned from this pandemic and we are hopeful that sharing some of this information will help others as they continue to gear up their studies and plans.

Please reach out to us if we can help in any way or would like to be included in any of our upcoming town halls.


Laurie Halloran, CEO |
Paola Murphy, Chief Client Officer |
Katie McCarthy, Chief Development Officer |
Sheila Gwizdak, VP, Quality |
Kim Raymer, VP, Regulatory Affairs |
Jason Milovanovic, VP, Clinical Development |