Lab results in International System of Units (SI) have been the requirement for FDA data submissions. However, FDA has sometimes requested data in conventional units for labeling purposes. The last FDA Study Data TCG has changed a “may require” to a “please submit” for conventional units. This topic has made its rounds through CDISC Sub-teams and PHUSE working groups. Seems FDA has sorted it out with providing the additional instruction to submit in a custom domain. Has anybody out there added the lc.xpt dataset to their eSubmission data packages yet?
Let me know what you’ve learned.
Lisa