Standards Implementation Issues with the CDISC Data Models

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Mission

This working group will identify specific challenges with implementing the CDISC data standards on individual study elements including topics such as reviewing the CDER common issues document, a similar issues list which will be provided from CBER, feedback from the legacy data conversion project, and other gaps identified across the review process. This group will prioritize the issues and begin to make recommendations for changes or best practices in using the standards as well as document successful implementation practices for sharing across the FDA and industry.

Join the Working Group

To subscribe to the working group mailing list click here

To assist with ongoing Study Data Reviewer's Guide efforts, please contact one of the following co-leads:
Joanna Koft: joanna.koft@biogenidec.com, Gail Stoner: GStoner@its.jnj.com, or Scott Bahlavooni: scottab@gene.com

Current Projects

Issues List

Media:Standards_Implementation_Issues_List.doc

Conference Calls and Minutes

WG4 18JAN2012
WG4 Kickoff Presentation
PhUSE Conf March 19th and 20th minutes
WG4 Update June 18 2012
Data Guide Teleconference July 23 2012
Discussion Club: FDA/PhUSE CSS Working Group 4 Update Budapest 2012
StudyDataReviewersGuide/CDISC_Interchange_2012

Overview

Purpose

FDA/Phuse has created an initiative in which several working groups have been developed to address important topics around the standardization and implementation of data. Working Group 4: Standards Implementation Issues with the CDISC Data Models hopes to identify some of the major issues with the data standards models and how both sponsors and FDA reviewers alike are interpreting them. Through discussion, we aim to reach a more unified understanding of their impact. Furthermore, the working group will develop work products in an effort to address the identified issues which are to be further defined.

Leadership

  • Helena Sviglin, CDER
  • Steve Wilson, CDER
  • John Brega, PharmaStat
  • Joanna Koft, Biogen Idec
  • Gail Stoner, J&J
  • Scott Bahlavooni, Genentech

Scope/Duration

Scope and Duration

The initial scope of this project includes tackling issues that industry is facing when implementing the SDTM model as well as the issues that FDA faces when reviewing SDTM data. This includes all facets of SDTM from both an industry and reviewer perspective. At this time, the scope of this initiative will not be including issues with other CDISC models such as ADaM, SEND, or Define.xml as these are being addressed in other working groups.

While the value of standardized data is recognized and appreciated, it is evident to both industry and FDA that there are significant challenges with understanding the SDTM model and how it is used. Sponsors and reviewers alike have expressed concern and identified some of the common issues that are recurring. Working Group 4 will discuss a prioritized list of these issues and construct “work products” that aim to improve our understanding of implementing standardized data and how it is used as well as facilitate better communication around standard data between Industry and FDA.

This is a year-long initiative, beginning with the two-day FDA/PHUSE conference on March 19-20. Volunteer members of Working Group 4 do not need to be present at the conference to participate throughout the year.


Governance

While the working group will begin with a set, prioritized list of common issues and challenges, others will certainly arise. The working group co-leads will maintain a log of proposed issues for discussion and their accompanying prioritization.

Goals/Objectives

  • Review prioritized list of common issues and challenges
  • Develop use cases for highest priority issues
  • Identify additional issues, prioritize, and maintain log
  • Create white paper and/or best practice documentation based on outcomes of discussions
  • Define meeting logistics for rest of year (frequency of meetings, type of meetings, etc.)


Disclaimer

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.