Study Data Research and Collaborations
The purpose of the study data standards is to enable the exchange of data between researchers and FDA. These tools aid in research and collaboration.
- Recommendations for the Submission of LOINC Codes in Regulatory Applications to the U.S. Food and Drug Administration - Recommendations document prepared by CDISC with input from the LOINC Working Group members (FDA, National Institutes of Health (NIH), CDISC, and Regenstrief Institute) and submitted to the FDA. The FDA plans to review the Working Group document and provide recommendations in the Study Data Technical Conformance Guide. NEW
- Data Standards Research Areas and Collaborations - Ongoing FDA study data exchange standards research and development activities.
- DS-XML Pilot Final Report (PDF - 152KB) (Apr. 2015) - Test Report for DS-XML Pilot Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER).
- Study Design Standard - Health Level Seven (HL7) Study Design Structured Document Standard (SDSD) captures both structured and unstructured information on the design of an investigational study.
- Stability Data Standard - HL7 standard to facilitate the processing and review of stability data.
- Study Participation Standard - Information about experimental units, investigators, and other relevant entities that are involved in the conduct of an individual study.
- Subject Data Standard - Information on an individual study subject, including observations, substance administration, supplies, and procedures.
- Janus Clinical Trials Repository - Data warehouse for subject-level clinical trial data submitted to FDA as part of marketing applications. The repository provides FDA staff easy access to clinical trial data to support regulatory review and to support analyses across studies that address public health and research questions as they emerge.