Optimizing the Use of Data Standards

Working Group & Project Scope

Working Group Leads

Jane Lozano

Janet Low

Over the last decade there has been a significant development and adoption of data standards, showing a promising improvement in the 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 aims to identify and close specific gaps that prevent the FDA and industry from optimising the use of data standards.

Data Reviewer's Guide in XML

Mike Hamidi

This project is developing the Data Reviewer's Guide (i.e. SDRG and ADRG) in an XML format for regulatory submissions and, furthermore, is identifying and developing style sheets, elements and semantics capability. It is also assessing a more cohesive cross-documentation data exchange between the Define-XML and Data Reviewer's guides in an XML format. The project intends to use the existing Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewer's Guide (SDRG) as its basis.

Clinical Integrated Study Data and Analysis Data Reviewer's Guide

Satheesh Avvaru

Kiran Kundarapu

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. 

SDTM ADaM Implementation FAQ

Bhavin Busa

Aatiya Zaidi

Amy Palmer

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, response to, and publishing of common SDTM and ADaM implementation challenges/nuances. This is important for sponsors who 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. Five primary categorical areas will be used for the FAQ.

Have a query about SDTM/ADaM? Use this form to submit your questions.

 

 

 

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