Study Start Date in SDTM – Why Getting It Right Matters
Study Start Date in SDTM – Why Getting It Right Matters Study Start Date in SDTM – Why Getting It Right Matters The Study Start Date (SSTDTC) is a crucial element in the submission of clinical trial data, especially in meeting regulatory requirements. Since December 2014, the FDA has provided explicit guidance on defining and utilizing this data point, but many sponsors and service providers face challenges in its consistent application. Missteps in defining the Study Start Date can lead to technical rejection during submission reviews, delaying the regulatory process. This article explores the definition, importance, and proper implementation of the Study Start Date in SDTM (Study Data Tabulation Model) submissions, based on regulatory guidance and best practices. FDA’s Definition of Study Start Date The FDA, in its 2014 guidance, clarified that the Study Start Date for clinical trials is the earliest date of informed consent for any subject ...