In 2014, the FDA published its first official list of validation rules for CDISC SDTM study data standards. These rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.
With the help of the implementation guide, which provides documentation of metadata (data about the data) for the domain datasets that includes filename, variable names, type of variables and its labels, etc.; we can then map to the CDISC Analysis Data Model (ADaM) to be able to submit to the regulatory agency. This provides a clear content, source and quality of the datasets submitted in support of the statistical analysis performed by the sponsor.
Learn the basics on how to implement CDISC data standards concepts on your clinical trials from study design to FDA data analysis submission.
Need SAS programmers, CDISC Subject Matter Experts (SMEs) or a clinical programmer? We can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.