Conformance with the tumor.xpt Specification

This project will develop an initial, non‑exhaustive set of technical conformance rules for the FDA’s tumor.xpt specification. Since 1999, industry has been required to submit tumour data in this format alongside SEND datasets. However, unlike SEND – which includes CDISC‑provided conformance rules – tumor.xpt has no formal validation framework and cannot be checked using standard automated tools. Because tumor.xpt is not a CDISC standard, CDISC will not supply such rules, leaving industry to manually verify compliance with FDA requirements. 

This project will create the first validator rules that can be implemented within existing SEND verification tools, reducing manual review effort and improving the overall quality and consistency of tumor.xpt files. Automating these checks is expected to shorten preparation time, decrease sponsor–FDA back‑and‑forth, and provide clearer insight into potential issues. If adopted by the FDA, these rules could also streamline regulatory review by identifying format problems earlier. 

Gitte Frausing, Data Standards Decisions

gfrausing@datastandardsdecisions.com

Hepei Chen, FDA

hepei.chen@fda.hhs.gov

Alex Pearce, PHUSE Project Coordinator

Alexandra@phuse.global