Sunday, March 11, 2012

Standardized study data for electronic submission - CDISC compliance

FDA has recently issued a series of draft guidance on “providing regulatory submission in electronic format”. The most recent one is about “providing regulatory submissions in electronic format – standardized study data”. We have heard a lot of discussions about CDISC, SDTM, ADaM,…While these data standards are not mandated yet, FDA is encouraging the submission of the electronic data in CDISC compliant format. The draft guidance about ‘standardized study data’ is another sign that the industry should move toward the compliance of the CDISC standards for the submission.
In terms of what kinds of data standards to be used in electronic submissions, please see FDA’s web pages on study data standards.
CBER may have a little bit different requirements from other divisions. CBER has its own resource page for submission of data in CDISC format to CBER
While CDISC standards may be good for FDA reviewers and may accelerate the review process, it will indeed add burdens to the industry. For the original clinical datasets, there will be additional mapping to be implemented in order to prepare the datasets in SDTM compliant formats. SDTM format is not user-friendly and sometimes it is several steps to link back to the CRF/eCRFs.
Other readings:


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