Data Guide Data Description

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Overview & Scope

The Data Description Data Guide sub-team will finalize annotated CRF, domain and controlled terminology content that should be described in the Data Guide. Provide recommendations for how to present said content within the Data Guide. Additionally, provide recommendations for which content should not be represented in the Data Guide, but should be represented in the study metadata.

Presentations and Working Documents

Data Description Kickoff Presentation

Data Description Section Content: This document lists topics for the Data Description section of the Data Guide. These topics will be ranked in order of perceived usability to a reviewer then logically ordered for presentation in the Data Guide.

Data Description Section Content Categorized: This document categorizes topics for the Data Description section of the Data Guide in order of perceived usefulness to an FDA reviewer.