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FDA has recently issued a series of draft guidance on “providing regulatory submission in electronic format”.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 The draft guidance about ‘standardized study data’ is another sign that the industry should move toward the compliance of the CDISC standards for the submission.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:

• Providing Regulatory Submissions in Electronic Format — General Considerations Regulatory Submissions in Electronic Format for Biologic Products
• CDER Common Data Standards Issues Document issued last month (Version 1.1/December 2011)
• CBER Process for Planning and Accepting CDISC SDTM and ADaM Formatted Submissions in CBER
• Assessment of the Impact of the Electronic Submission and Review Environment on the Efficiency and Effectiveness of the Review of Human Drugs – Final Report
• Assessment of the Impact of the Electronic Submission and Review Environment on the Efficiency and Effectiveness of the Review of Human Drugs – Final Report