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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.