Data Validation and Quality Assessment

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Current Projects

Please follow the links below to view the current project(s):

  1. SDTM Validation Rules Project

NOTE: Bi-weekly meetings will be held Monday 2-3pm starting April 22nd
Email invitations will be sent soon to those subscribed to the Improving Data Quality email list.

To join the team, please contact one of project leads [Mike Molter] or [Majdoub Haloui]

Completed Projects

  1. Group 1 - Develop Guidelines for Validation Rule Developers (Mitra)
  2. Group 2 - Assess and Improve Existing Validation Rules (Amy)
  3. Group 3 - Design Change Management Process (Armando)
  4. Data Sizing Best Practices Recommendation
  5. Top 20 Validation Rule Failures
  6. CAB/VP and OpenCDISC Rules Reconciliation Project
  7. Guidelines for Validation Rule Developers - Complete
  8. Change Control Board (CCB) for Study Data Validation Rules Charter - Complete


This working group will focus on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through the product life cycle across both industry and regulatory review. The group will discuss current pains and potential solutions around topics such as the current data validation rules as well as the CDISC Data Validation Project, development and implementation of tools, terminology, and improving the quality of the data to support analytical needs.


FDA recently has embarked on an aggressive effort to modernize the review process that will rely on high quality standardized data to streamline acquisition, analysis, storage and reporting. This new process takes a “reviewer-centered” approach where improved data quality, accessibility and predictability will allow reviewers more time to carry out complex analyses, ask in-depth questions and address late-emerging issues. To support the transition to a more advanced review process, FDA has initiated the Data Validation Project. The objective of the project is to evaluate existing validation rules, craft new validation rules, and implement tools to enable systematic, automatic and regular evaluation of data quality and standards conformance at the time of product submission. The project will inform reviewers of characteristics of submitted data, allow for cross-submission assessment of potential problem areas, and help generate a better understanding of several key factors related to data standards adoption, including the rate of uptake of standardized data by sponsors, the degree of adherence to the specified standards, and the ability of reviewers to use standard-specific advanced review methods/tools.


Name Role Organization E-mail
Max Kanevsky Industry Co-lead OpenCDISC mkanevsky (at)
Hany Aboutaleb Industry Co-lead Biogen Idec hany.aboutaleb (at)
Doug Warfield FDA Co-lead FDA - CDER Douglas.Warfield (at)
Lisa Lyons Project Manager Janssen llyons3 (at)
Charles Cooper Steering Committee Liaison FDA - CBER Chuck.Cooper (at)
Anne Russotto Steering Committee Liaison Celgene arussotto (at)


The success of FDA initiatives depends on close collaboration with industry stakeholders including standards development organizations, sponsors, and academia. The approach for this working group is to provide a platform enabling open communication between FDA and industry to share ideas, experiences and expectations, and to facilitate joint development of validation rules and processes to assess data quality and standards compliance throughout the product life cycle.


The workgroup will initially focus on SDTM Validation Rule 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.

How to join

If you are interested in joining a working group 1, follow the instructions below.

  1. Navigate to
  2. Enter in one of the four groups below:
    • WG1-Data-Validation (Working Group 1: Data Validation and Quality Assessment)
  3. Enter your e-mail and click submit. You will then be prompted to enter your First and Last name which is required to participate in the working group 1
  4. You will then receive an e-mail that will provide a link for you to confirm your e-mail (Check those spam folders just in case)
  5. You are now subscribed and should receive information about upcoming meetings from working group co-leaders!

Meeting Minutes

Data Quality Leadership Team Minutes


Group Meeting Agenda

May 20 2012 Meeting Agenda

Group Discussion

Discussion Club: FDA/PhUSE CSS Working Group 1 Update Budapest 2012

Group Findings

Group Follow up

If you have questions, please contact WG1 Co-lead .


FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.