federal_register: 2013-28391
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-28391 | Transport Format for the Submission of Regulatory Study Data; Notice of Pilot Project | Notice | The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) are announcing a pilot project to evaluate the Clinical Data Interchange Standard Consortium (CDISC) Submission Data Standards (SDS) Extensible Markup Language (XML) transport format for the submission of regulatory study data. The current study data transport format supported by FDA is the SAS Transport (XPORT) version 5 file format. Although XPORT has been a reliable exchange format for many years, it is not an extensible modern technology. SDS XML is an extension of the CDISC Operational Data Model, which is a vendor neutral, platform-independent format for the exchange and archive of study data. FDA is announcing an invitation to sponsors to participate in this pilot project to evaluate the SDS XML transport format. | 2013-11-27 | 2013 | 11 | https://www.federalregister.gov/documents/2013/11/27/2013-28391/transport-format-for-the-submission-of-regulatory-study-data-notice-of-pilot-project | https://www.govinfo.gov/content/pkg/FR-2013-11-27/pdf/2013-28391.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) are announcing a pilot project to evaluate the Clinical Data Interchange Standard Consortium... |