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 is on Tuesday the December 2
and second one is on Wed, Dec 3.
FDA
Official Validation Rules for Submission Data
Wednesday, December 3
at 2:00 PM EST
Click on the above links to register for the webinar.
Best,
Sarath
