Improving Data Quality

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Working Group Overview

This working group will focus on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through product lift cycle across both industry and regulatory review. The group will discuss current pains and potential solutions regarding topics such as current data validation rules, therapeutic specific data issues and improving the quality of the data to support specific analytical needs.

Leadership Team

Name Role Organization E-mail
Max Kanevsky Industry Co-lead OpenCDISC mkanevsky@pinnacle21.net
Lisa Lyons Group Coordinator J&J LLyons3@its.jnj.com
TBD Industry Co-lead FDA TBD
Anne Russoto Steering Committee Liaison Celgene arussotto@celgene.com

Current Projects

TBD

Legacy Projects/Information

Guidelines for Validation Rule Developers

Change Control Board (CCB) for Study Data Validation Rules - Charter

Top 20 Validation Rule Failures

CAB/VP and OpenCDISC Rules Reconciliation Project