Evaluation of SDTM Elements
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.
|Joanna Koft||Industry Co-Lead||Biogen-Idec||joanna.koft (at) biogenidec.com|
Provide project updates in this section.
Date: Description of Update
Objectives and Timelines
|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|