Table of Contents
Web Submission Data Manager (WebSDM) DEMONSTRATION Steve Wilson, DrPH Deputy Director, Division of Biometrics II, CDER
Road Map
Electronic Document Room
Folders for Submitted Data, CRFs and Labeling (partial e-sub)
Folders for Datasets & Domains
Folders for Studies
Folders for Datasets
Datasets
Download to Desktop Tools
Login
Web Submission Data Manager
Search Applications
Select Application
Select Study
Submitted Data
Display Observations
Details
Review Definitions/Source
Create Report
Select Domain and Timing Variable
Select Topic, Qualifier, Demographic Variables & Report “Type”
Review Selections
Graph From a Report
Make Slections/Display Graph
Copy From WebSDM
Paste Into Review
Select Patient of Interest
Select View
Examine Patient Profile
Display and Choose Saved Reports
Examine Selected Report
Display Data/Functions
Thank You wilsons@cder.fda.gov 301-827-5583
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Author: WILSONS
Home Page: http://www.fda.gov/cder/regulatory/ersr/default.htm
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