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Mind the Gap! How to prepare for SDTM migrations.
Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create CDISC compliant outputs as part of their in-line study analysis and reporting, inevitably legacy conversion of older studies is required.
A legacy conversion project is one which requires a significant transformation effort, where neither CDASH nor SDTM has been used. Migrating to SDTM is of course a complex activity, requiring a precise and intelligent approach- it’s not just a matter of renaming variables. A gap analysis which assesses the current state of the data can ensure the project is commenced on the right footing. In the below example, we conducted a gap analysis as part of a project for a client who engaged Cytel for support with their ISS/ISE.