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Compliance In Focus
Posted by John Lehmann on Mon, Feb 27, 2012

Should the FDA Require Standardizing Data Submissions?

Recently the FDA released a Guidance for Industry on “Providing Regulatory Submissions in Electronic Format — Standardized Study Data.” This guidance expresses the FDA’s recommendation that sponsors submit clinical and nonclinical data in a standard electronic format.  In the guidance the FDA points out that standardizing study data makes the data more useful. “Data that are standardized are easier to understand, analyze, review, and synthesize in an integrated manner in a single study or multiple studies, thereby enabling more effective regulatory decisions.”

For the medical device, drug, and biologic industries, this draft guidance applies to study data involving:

- Investigational new drug applications (INDs)
- New drug applications (NDAs)
- Abbreviated new drug applications (ANDAs)
- Investigational device exemptions (IDEs)
- Biologics license applications (BLAs)
- Premarketing notifications (510(k)s)
- Premarketing approval applications (PMAs)

This is a stark contrast to data submitted via paper report forms (CRFs) and tabulations (CRTs) which are not machine readable. The FDA feels that “non-standardized data diminishes the Agency’s ability to review the data efficiently, resulting in manual, labor-intensive processes and inherent inefficiencies in the review.”

According to the notice on the Federal Register’s website one of the purposes of the draft is to increase the number of standardized study data submissions to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

 Furthermore, the guidance includes information on the related topics of:

- Planning and providing standardized study data
- Controlled terminologies
- Standardization of previously collected nonstandard data
- Data validation
- Exceptions to standardized stud submissions

What are your thoughts on the FDA encouraging standardized electronic submissions? Do you have anything to add to the guidance? Share your thoughts with us below.

Topics: Clinical Data, Standardizing Data Submission, FDA


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