Regulatory Focus™ > News Articles > FDA Wants New Study Data Exchange Format

FDA Wants New Study Data Exchange Format

Posted 13 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling for comments from industry and the public on the development of standards for study data exchange standards.

In a 13 August 2012 Federal Register notice, FDA said it would be holding a meeting to assess the suitability of the current study data exchange format, the ASCII-based SAS Transport (XPORT) version 5 used by its drugs, biologics and devices regulatory centers. Though FDA said the standard has been in place for a number of years, it lacks the extensible qualities of more modern standards like XML that allow for interoperability and the review, analysis and reporting of large amounts of data as efficiently as possible.

Also at issue for FDA: the XPORT data standard is, "Not supported and maintained by an open, consensus-based standards development organization." The agency said its meeting will be geared toward understanding the costs and benefits of moving to a new study data exchange standard and determining the next steps to formulate a plan of action.

Ten main categories of questions will guide the meeting, FDA said. Among them:

  1. What are the most pressing challenges that industry faces with regard to study data management?
  2. How could FDA's regulatory requirements make the study data management process more efficient?
  3. What does industry need to make clinical trials data management more effective and efficient? 
  4. What data standards are you currently using for the conduct of regulated research studies?
  5. Would Health Level Seven v3 (e.g., messages, structured documents and Clinical Data Architecture) be a viable study data exchange standard?  What would be the impact?
  6. Would CDISC Operational Data Model be a viable study data exchange standard? 
  7. Are there other open data exchange standards that should be evaluated?  What would be the impact?
  8. What would be a reasonable phased implementation period for each recommended exchange standard?  And should supporting multiple, concurrent study data exchange standards be evaluated?  What can FDA do to help industry be more prepared for, or reduce the burden of, a migration to a new study data exchange standard?
  9. FDA encourages sponsors to design study data collection systems so that relationships between data elements, as well as relationships across data domains, can be captured at the point of data entry.  Describe the challenges to, and opportunities for, accomplishing this goal.
  10. What other comments would you care to share with FDA concerning the general topic of data exchange standards?

FDA also asked sponsors to note the financial, technical and implementation costs of alternatives, as well as guidance documents that might be necessary to define potentially murky areas.

The meeting will be held on 5 November 2012 at FDA's White Oak Campus in Silver Spring, MD.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.