Optimizing the Use of Data Standards

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Working Group Overview

The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps preventing FDA and industry from optimizing the use of standards and collaborate to close those gaps.

Leadership Team

Name Role Organization E-mail
Scott Bahlavooni Industry Co-lead Genentech bahlavooni.scott (at) gene.com
Michael Brennan Steering Committee Liaison Janssen R&D MBrenna3 (at) its.jnj.com
Jeff Conant Group Coordinator Vertex Jeffrey_Conant (at) vrtx.com
Jingyee Kou FDA Co-Lead FDA jingyee.kou (at) fda.hhs.gov
Steve Wilson FDA Co-Lead FDA Stephen.Wilson (at) fda.hhs.gov

Current Projects

Traceability and Data Flow - Traceability challenges arise at a study level when raw data is converted to SDTM after the fact, while analysis datasets and the study report trace back to the original raw data source. This project will discuss and define traceability considerations and best practices for study level and integrated dataset conversion for a variety of different data flow scenarios.

(NEW) CDRH Pilot for the ElectronicSubmission of Medical Device Data in an SDTM-Based Format - With the recent development of new SDTM-based device domains, industry and CDRH would like to conduct a Pilot to evaluate the use of the domains for submission.

(NEW) Analysis Data Reviewer's Guide (ADRG) - ADaM “provides a framework that enables analysis of the data, while at the same time allowing reviewers and other recipients of the data to have a clear understanding of the data’s lineage from collection to analysis to results. Although ADaM provides a robust metadata framework, FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, datasets, and programs that cannot be fully explained within the ADaM metadata. The development of an Analysis Data Reviewer’s Guide (ADRG) template will ensure this documentation is provided to the agency in consistent and usable format.

(NEW) Evaluation of SDTM Elements - Sponsors collect data elements to support operational activities such as data cleaning or data reconciliation. Although these data elements are not analyzed, sponsors frequently tabulate them in SDTM. As a result, both sponsor analysts and FDA Reviewers spend time differentiating analyzable observations from operational noise. Documenting data elements of limited utility to data analysis and/or FDA Reviewers provides sponsors and the agency with a common baseline for pre-submission data standards discussions.

Completed Projects

Study Data Reviewers Guide (SDRG) - The define.xml document does not adequately document mapping decisions, sponsor-defined domains, and other key study components and a SDRG would help to address this documentation gap. The goal of this project is to develop a SDRG template jointly between CDER, Industry, and CDISC to be used for submissions.

Working Group Meeting Materials

Teleconference: Conference Info: 888-706-6468 Participant Code: 2210463
Adobe Connect Session: https://connect.vrtx.com/jeff
Teleconference Agenda: Next Meeting 12-June-2013 11:00 - 12:00 EST Review Quarterly Status Reports

Meeting Minutes:

Date Presentations Meeting Minutes Meeting Recording
10 Apr 2013 NA Meeting Minutes
12 Jun 2013 Quarterly Status Updates Meeting Minutes

Legacy Projects/Information

Standardizing Site Selection