|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).
Tuesday, September 1, 2020