While XML exports and archives are the preferred format for FDA/CVM submission, the older SAS xport (XPT) format is still allowed by and is being used by some companies for their data submission. VISION™ has always provided XML format and and now it’s possible for you to generate XPT files, on-demand, of any and all your data.
The three acceptable file formats for FDA/CVM submission are XML, XPT and PDF. The choice of which format is largely in the hands of the sponsor uploading the data via e-Submitter. A PDF option is currently available as part of the final archive but Prelude’s VISION™ platform provides Clients with the ability to export both XML and XPT files directly from within the system. Log in, select your data set, and click to download.
XPT has been around for a long time and as such is used in a legacy fashion by those that have been working in the industry for decades. XPT has some limitations, as its variable names are constrained to a maximum of 8 characters; labels, to 40 characters and maximum variable value is 200 characters. The 8 character variable names must be unique and usually require a dictionary (README) that explains what each of the cryptic 8 character names really mean. Despite these limitations, XPT offers the advantage that SAS will read it into row/column tables very quickly compared to SAS’s ability to read XML format.
XML format, which is the VISION™ platform’s raw source data format, is more robust than XPT. It allows data to be stored hierarchically with multiple levels. This provides many advantages in non-proprietary readability without XPT limitations. The FDA has recognized this and for more than a decade has provided guidance on the move to XML in conjunction with standards such as C-DISC and SEND.
In conclusion, even as the XPT format fades away to be replaced by the more robust XML format, Prelude has added the XPT file format to be exported and downloaded with the same ease as XML files. This provides the legacy transformation of XML to XPT at the push of a button and provides Clients with more choices and compatibility and flexibility for older software tools.