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Yesterday, FDA published its first official list of validation rules for CDISC SDTM. These long awaited 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.
For Official list of rules, here is the direct link for the FDA website: http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm
The FDA is asking sponsors to validate their study data before submission using these published validation rules and either correct any validation issues or explain, why they could not be corrected, in the Study Data Reviewer’s Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission.
Open CDISC is offering a webinar on the official list of validation rules. They are offering 2 sessions, 1…
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| This post was kindly contributed by StudySAS Blog - go there to comment and to read the full post. |