Mind the Gap! How to prepare for SDTM migrations.

Posted by Cytel

Mar 8, 2016 9:30:00 AM

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.

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Topics: Statistical Programming, ISS, ISE, CDISC, SDTM


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