Evaluation of SDTM Elements

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Project Overview

Sponsors collect data elements to support operational activities such as data cleaning or data reconciliation. Although these data elements are frequently being tabulated in SDTM by the sponsors, they are not being used in analyses that support the Clinical Study Report. As a result, both sponsor analysts and FDA Reviewers spend time differentiating analyzable observations from operational noise. Documenting data elements that are not being used in analyses that support the Clinical Study Report provides sponsors and the agency with a common baseline for pre-submission data standards discussions.

Project Leads

Name Role Organization E-mail
Joanna Koft Industry Co-Lead Biogen-Idec joanna.koft (at) biogenidec.com
TBD Industry Co-Lead Company email
TBD FDA Co-Lead Company email

Project Updates

Provide project updates in this section.
Date: Description of Update

Objectives and Timelines

Objective Timeline
Review and modify existing proposed list of data elements from 2012 FDA/PhUSE CSS meeting (including examples and rationales for each data element) CSS Meeting
Formally document data elements and provide the documentation to the FDA co-lead 1 month

Project Activities

Meeting Minutes

Archived Content

SDTM Submission Exceptions (2012 CSS)