The US FDA wants CROs, sponsors and the wider industry to debate the pros and cons of current and evolving approaches to sharing study data.
According to a publication in the Federal Register the Food and Drug Administration (FDA) wants industry and technology vendors and the general public to share their thoughts on the subject at a meeting due to be held at its White Oak Campus on November 5.
The agency said that current exchange format - ASCII-based SAS Transport (XPORT) version 5 – has been used for many years and is not an extensible modern technology or supported and maintained by an open, consensus-based standards development organization.
“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. 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.”