In the United States,
the approval process for regulated human and animal health products
requires the submission of data from clinical trials and other studies
as expressed in the Code of Federal Regulations (CFR). The FDA established
the regulatory basis for wholly electronic submission of data in 1997
with the publication of regulations on the use of electronic records
in place of paper records (21 CFR Part 11). In 1999, the FDA standardized
the submission of clinical and non-clinical data using the SAS Version
5 XPORT Transport Format and the submission of metadata using Portable
Document Format (PDF), respectively. In 2005, the Study Data Specifications
published by the FDA included the recommendation that data definitions
(metadata) be provided as a Define-XML file.
On November 5, 2012,
the FDA held a meeting entitled “Regulatory New Drug Review:
Solutions for Study Data Exchange Standards”, the purpose of
which was to solicit input regarding the advantages and disadvantages
of current and emerging open, consensus-based standards for the exchange
of regulated study data. CDISC Dataset-XML was presented as an alternative
for consideration.
In 2014, the FDA conducted
a pilot to evaluate CDISC Dataset-XML as a solution to the challenges
of the SAS Version 5 XPORT transport.