TreeScan in Pregnancy

Project Title TreeScan in Pregnancy

The goals of this methods project are to evaluate the performance of TreeScan to assess maternal and infant outcomes, test signal identification methods in a pregnancy setting, and evaluate methods performance using older drugs with relatively well-characterized safety profiles. 

The Sentinel Operations Center posted this final draft protocol for public comment from June 19, 2020 through July 6, 2020. The public comment period is now closed. A revised version was approved for implementation by FDA on August 17, 2020. A log of changes is included in the revised protocol (v2).

Published Date
Tuesday, September 1, 2020
Ongoing Projects
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