Accelerating FDA Submissions with the Trial Summary Domain

A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, the study start date is earliest date of informed consent from any subject enrolled in the study, whereas nonclinical studies use the study initiation (protocol finalization) date. This article reviews the importance of the study start date and makes recommendations to help ensure a successful submission for current and legacy studies.

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