Navigating Complexities: Integrating Data from Ongoing Studies in Regulatory Submissions
Integrating data for regulatory submissions requires organizing and consolidating information from multiple studies for a project. The activities could include aligning variables from studies using different versions of CDISC standards and/or creating new variables to support integrated analyses. BUT, what happens when another layer of complexity is added? What if an ISS or ISE will include data from ongoing studies? What are key considerations when dealing with ongoing data?
