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 efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. This working group will identify specific gaps that prevent FDA and industry from optimizing the use of data standards. This working group will collaborate to close those gaps. On this page you will find information on Current and Completed projects.

Leadership Team

Name Role Organization E-mail
Janet Low Working Group Leader Merck janet_low@merck.com
Jane Lozano Working Group Leader Eli Lilly lozano_jane_a (at) lilly.com
Bess Leroy CDISC Liaison CDISC bleroy@cdisc.org
Wendy Dobson PHUSE Project Manager PHUSE wendy@phuse.eu

Completed Projects

Reviewer's Guide Work Packages referenced in FDA Study Data Technical Conformance Guide

The current Analysis Data Reviewer's Guide and Clinical Study Data Reviewer's Guide deliverables are located on the PHUSE website at the following link:

Prior versions of the reviewer's guides are located on the PHUSE website at the following link:

Traceability and Data Flow Deliverables

Can be found on the PHUSE White Papers Deliverables Page

Wiki pages with deliverables

Standardizing Site Selection

Current Projects

Working Group Description Recruiting New Members
Best Practices for Data Collection Instructions This project, in collaboration with CDISC, will provide new CDISC implementers a primer to assist in the creation of standardized data to regulatory authorities. The project will identify needs of new implementers with an additional focus on academia and technology providers. The deliverable format (e.g. Wiki, white paper, slide deck, quickstart guides, etc.) will be made freely available to the public. Yes
CDISC Implementation Primer This project, in collaboration with CDISC, will provide new CDISC implementers a guide to providing study data in standardized format to regulatory authorities. There will be an additional focus on academia and technology providers. The deliverable is a "CDISC Primer" (e.g. Wiki, white paper, slide deck, quickstart guides, etc.) will be developed to address this need and will be made freely available to the public. No
Data Reviewer's Guide in XML This project will develop the Data Reviewer's Guide (i.e., SDRG and ADRG) in an XML format for regulatory submissions. Furthermore, this project will identify and develop style sheets, elements and semantics capability. This project will also assess a more cohesive cross-documentation data exchange between the define.xml and data reviewer's guide as an XML format. The project intends to use the existing Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewers Guide (SDRG) as its basis. No
Data Standards for Non-Interventional Studies This project addresses the challenges that programmers face during creation of the analysis datasets and handling of the data for the observational studies. The deliverable is a white paper documenting the challenges and possible solutions. Yes
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities This project provides a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information. No
Clinical Integrated Study Data and Analysis Data Reviewers Guides The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer’s guide for integrated Study Data and a reviewer’s guide for integrated Analysis Data. The template has to be changed in order to document the information for multiple studies. There is an opportunity to create a template for integrated Study Data and integrated Analysis Data. The project team will determine if this can be accomplished in one reviewer’s guide or if there should be two separate reviewer’s guides. Deliverables include a template, completion guidelines, and example documents. Yes
SDTM ADaM Implementation FAQ Standard implementation nuances exist across the multiple available versions of SDTM and ADaM. The project team will establish a framework for the collection, compilation, assessment, responding to, and publishing common SDTM and ADaM implementation challenges/nuances. This is important for Sponsors that are still transitioning to newer versions of standards (e.g. SDTM), as well as the vast majority who have to govern multiple versions, even for a single product or application. This is a joint project between PHUSE and CDISC. Yes

Projects on Hold

CDRH Pilot for the Electronic Submission of Medical Device Data in an SDTM-Based Format - This project has been put on hold until further notice (2014-01-07).

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. This project has been put on hold until further notice (2014-05-13).

Working Group Meeting Minutes

2020 CSS

This year the CSS will be virtual! On behalf of Janet and myself, we hope you can join us in the breakout sessions and working group discussions.

The breakout schedule will be here soon.

Note that there will be an opening session for this working group Monday morning (September 21). A summary of the working group projects will be presented, including a brief agenda for the projects that are having break out sessions.

We will also have a working group wrap-up and round-table breakout session on Wednesday (September 23). Each of the working group leads will communicate the accomplishments during the conference and the path moving forward. This is also an opportunity to discuss ideas for new projects and communicate that with the working group co-leads.

If you have any questions or concerns, please reach out to Jane Lozano or Janet Low.

Webinar Presentations

CSS Presentation

Maintaining the Clinical & Nonclinical Study Data Reviewers Guides