Project Scope
The scope of the project will be to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification.

Problem Statement
Since 1999, the FDA has requested that industry provide tumour data from nonclinical studies in a specified format (‘tumor.xpt’). This data is now submitted jointly with SEND datasets. Where the SEND standard comes with a set of conformance rules from CDISC, the tumor.xpt specification does not have these, and consequently this file, unlike the adjoining SEND datasets, is not currently validated using out-of-the-box tools. Since the tumor.xpt format is not a CDISC standard, it is confirmed that the CDISC SEND team will NOT provide such conformance rules with the tumor.xpt format. Consequently, there is currently a manual burden on industry to verify the adherence of the tumor.xpt file to the FDA specification.

Problem Statement

Since 1999, the FDA has requested that industry provide tumour data from nonclinical studies in a specified format (‘tumor.xpt’). This data is now submitted jointly with SEND datasets. Where the SEND standard comes with a set of conformance rules from CDISC, the tumor.xpt specification does not have these, and consequently this file, unlike the adjoining SEND datasets, is not currently validated using out-of-the-box tools. Since the tumor.xpt format is not a CDISC standard, it is confirmed that the CDISC SEND team will NOT provide such conformance rules with the tumor.xpt format. Consequently, there is currently a manual burden on industry to verify the adherence of the tumor.xpt file to the FDA specification.

Problem Impact
This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file. The benefit for industry, with an automation of these checks, will be increased quality of the tumor.xpt file and reduced time to generate it. With an increased quality of the tumor.xpt file, it is expected that less communication will be needed between sponsors and the FDA to discuss potential issues with the tumor.xpt file. Should the FDA decide to adopt these conformance rules, they can benefit by getting an early insight into any potential issues they could encounter when reviewing the data, thus also increasing actual data review time and not spending it on identifying and correcting issues with the format.

Problem Impact

This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file. The benefit for industry, with an automation of these checks, will be increased quality of the tumor.xpt file and reduced time to generate it. With an increased quality of the tumor.xpt file, it is expected that less communication will be needed between sponsors and the FDA to discuss potential issues with the tumor.xpt file. Should the FDA decide to adopt these conformance rules, they can benefit by getting an early insight into any potential issues they could encounter when reviewing the data, thus also increasing actual data review time and not spending it on identifying and correcting issues with the format.

Project Leads	Email
Gitte Frausing, Data Standards Decisions	gfrausing@datastandardsdecisions.com
Hepei Chen, FDA	hepei.chen@fda.hhs.gov
Alex Pearce, PHUSE Project Assistant	Alexandra@phuse.global

CURRENT STATUS Q1 2025
Completed more than half of the conformance rules.

Objectives & Deliverables	Timelines
Kick off meeting and agree on a regular meeting schedule	Q2 2023