The FDA is announcing a meeting “Regulatory New Drug Review: Solutions for Study Data Exchange Standards,” on Nov. 5, to solicit input from industry, technology vendors and the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The FDA also is seeking input from stakeholders on pre-meeting questions discussed below. Registration is required in advance and will be limited.

The current study data exchange format supported by FDA is the ASCII-based SAS Transport (XPORT) version 5 file format. Although XPORT has been an exchange format for many years, it is not an extensible modern technology. Moreover, it is not supported and maintained by an open, consensus-based standards development organization.

The FDA would like to discuss the current and emerging open study data exchange standards that will support interoperability. Currently, the use of XPORT can be described as an example of the exchange of study data between two or more systems using a specified file format (e.g., XML, SQL, ASCII). However, the desired path forward is to achieve interoperability with other systems where the exchange of data between systems can be reviewed, analyzed and reported with minimal need for data integration.

Based on feedback from this meeting and other information, an evaluation of the cost-benefit of a migration to a new study data exchange standard—on both FDA and regulated industry—will be conducted to inform next steps, which will include an action plan.

The FDA seeks input from stakeholders and other members of the public on the following pre-meeting questions:

1. What are the most pressing challenges that industry faces with regard to study data management? Please address each of the following areas: (a) Study design/set-up, (b) capture, (c) integration, (d) analysis, (e) reporting, and (f) regulatory submission. What opportunities/solutions exist to meet each challenge?

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? Please describe the tools, techniques, and processes that would help as well as the regulatory guidance documents that would be useful in this area.

4. What data standards are you currently using for the conduct of regulated research studies?

5. Would Health Level Seven v31 (e.g., messages, structured documents and Clinical Data Architecture) be a viable study data exchange standard? Please explain advantages and disadvantages. What would be the impact (e.g., financial, technical, or in terms of implementation or change in business processes)?

6. Would CDISC Operational Data Model2 be a viable study data exchange standard? Please explain advantages and disadvantages. What would be the impact (e.g., financial, technical, or in terms of implementation or change in business processes)?

7. Are there other open data exchange standards that should be evaluated? Please explain advantages and disadvantages. What would be the impact (e.g., financial, technical, or in terms of implementation or change in business processes)?

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 (please explain advantages and disadvantages of this approach)? What can FDA do to help industry to be more prepared for, or reduce 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?