SDTM Validation Rules Project
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.
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
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