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Running a trial amid COVID-19 is one thing, capturing the data accurately for it is another.
Maintaining data integrity is critical when conducting a clinical trial. One of the key strategies was to keep abreast of the guidance being released. Specific guidance was provided by FDA, CDISC, and MedDRA for what data related to the pandemic needed to be captured in trials, how it was to be captured and how it was to be coded. We implemented these across all ongoing and future studies.
Katherine Welsh, Nutrasource's Data Manager, explains how we were able to adapt and maintain integrity of our clinical trial data.