SDTM Validation Rules Project

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Purpose

The purpose of this project is to continue the effort of improving SDTM validation rules, ensuring that all rules are both clear and effective for use by industry and by FDA. The goal is to determine new rules that will add value and manage rules that need clarification. This will involve coordinating with CDISC, OpenCDISC and FDA to propose solutions.

Background

The SDTM Validation Rules project will continue the progress that was made in the “CAP/VP OpenCDISC Rules Reconciliation and the “Top 20 Validation Rule Failures projects in 2012.

Version 1.4 of OpenCDISC, which will be released in March 2013, has put in place many of the recommendations from these projects. The 2013 SDTM Validation Rules Project will address the yet un-resolved rule discussions, as well as those that are of special interest to FDA.

During the FDA/PhUSE CSS Conference March 18-19 the group reviewed and discussed 28 of 45 rules. The group will continute to provide potential solutions and collaborate with FDA, CDISC as well as update and refine the current data validation rules. The concept of White Papers was also discussed to highlight some of the most common issues encountered by the FDA.

FDA/PhUSE CSS March 18-19 Project Breakout Session Presentations


FDA Presentation: Rules for Discussion CDER/CBER Top Issues - 2013PhUSEBreakoutCABVP-CBER-CDER.pptx
OpenCDISC v1.4 Update - Workgroup1-OpenCDISC_Updates.pptx

Rules Currently Under Review


SDTM Validation Rules for Discussion - SDTMValidationRules.xlsx

BEST PRACTICE DATA SIZING RECOMMENDATION AND SUPPORTING DOCUMENTATION


Data Sizing Best Practice Recommendation http://www.phusewiki.org/wiki/index.php?title=Data_Sizing_Best_Practices_Recommendation

Supporting Documentation: Sizing of SDTM Variables and Datasets - Sizing Discussion Document.docx - Author Carlo Radovsky

Bi-Weekly Meeting Minutes

All minutes are now on one page!
SDTM Validation Minutes 2013