Over the past decade, CDISC Standards have been widely accepted and implemented in clinical research. The FDA’s final “Guidance for Industry on electronic submission” mandates that submission data conform to CDISC standards, including SDTM, ADaM and SEND. Life sciences organizations, therefore, need to ensure that submission data be compliant to regulatory requirement standards (e.g., CDISC and eCTD). One of the biggest challenges, however, that organizations face is the evolution of standards, which lead the different versions of standards. The presentation will discuss how organization manage the different versions of industry standards and company standards. The presentation will introduce governance on metadata management.
Standards governance simply means “Do the right things” in standards implementation and management. The presentation will discuss how life sciences organizations can better fulfill their goals for standards implementation and management using governance. The presentation will also discuss the main aspects of data governance from the CDISC standards perspective, addressing the role of people(e.g., requestor, developer and approval), processes(e.g., work flow of requesting, developing and approving), and technology (e.g., spreadsheet, share point and MDR).