If you’re attempting SDTM mapping and converting data to SDTM, you should have a basic knowledge of how SDTM works. If you’re interested you can read more on SDTM on our blog post All you need to know about SDTM . The best practice is always to align with CDISC standards before you collect any patient data. In order for clinical trial data to be analyzed and accepted by regulatory reviewers, CDISC standards must be adhered to. If CDISC standards haven’t been implemented from the start, it’s going to take a lot more time and effort when it comes to SDTM mapping later on. An example is mapping datasets from the structure used in your clinical data management system, or from another similar database to a CDISC SDTM structure. That is mapping datasets from a non-CDISC structure to the CDISC SDTM structure. One of the most challenging programming problems in a clinical trial involves SDTM mapping.
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