Standardizing the Standards: A Road Map for Establishing, Implementing and Unifying Standards in Your Organization

Electronic data submission is the future of clinical trials and reviewers will soon have the statutory authority to reject submissions that do not conform to expectations (e.g., via PDUFA V, section XII in the US). Data standards comprise the core of these expectations with the Standard Data Tabulation model (SDTM) standards as the centerpiece. The extensive body of existing guidance is undergoing rapid development and expansion, including the addition of therapeutic area standards which supplement and extend the existing SDTM implementation guidance. As the deadline for standardized submissions approaches, it is incumbent upon all organizations involved in the pharmaceutical industry to internalize the standardization of data collection, transformation, and analysis to ensure compliance with emerging regulatory requirements. This paper explores the challenges of developing, implementing, and maintaining organizational SDTM standards that are flexible, current and harmonized with industry standards. We illustrate how a standards initiative can be established and managed, highlighting the fundamental need for organizational commitment, the value added by SDTM and functional area subject matter experts, and the importance of an extensible infrastructure that provides process and content support to study teams. This infrastructure encompasses standard CRFs, comprehensive mapping specifications, programming tools, and an extensive professionalization of standards knowledge including in-depth training and standards implementation support for study teams. We will discuss this initiative, outlining the challenges and opportunities along with providing a roadmap for ongoing development activities to maintain currency, while extending and embedding the role of standards in the organization.