SS P08 Demographics, Disposition, Medications White Paper

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White Paper Title and Lead

Title = Analyses and Displays Associated with Demographics, Disposition, and Medication in Phase 2-4 Clinical Trials and Integrated Summary Documents
Lead = Simin Baygani

Status

Version 2.0 was finalized March 2018. The final white paper is available in the PhUSE Deliverables Catalog.

Version 1.0 was finalized on 07OCT2014.

Plan

We imagine there will be a version 3.0 at some point, but there are no immediate plans. Any comments on version 2.0 can be entered on this wiki page in the Notes section.

History

First draft sent for review 19FEB 2014 [1]

Several topics were discussed during the PhUSE CSS March 2014 Meeting: See SS P08 18March2014 Standard Scripts Project 08 Meeting for meeting minutes.

The second draft sent for review 26 June 2014 Analyses and Displays Associated with Demographics, Disposition, and Medication in Phase 2-4 Clinical Trials and Integrated Submission Documents

Version 1 was approved on 07OCT2014.

Notes

  • Next version - Consider changing the title of Prior Medications to something like Medications during Screening

Category Identification


Last revised by MaryNilsson,03/22/2019