Birdwatch Note Rating
2024-05-20 20:38:53 UTC - HELPFUL
Rated by Participant: 41012C2E36FB314C5AF18446A34B55E107869A748477CD7A5F73DB739E07FFC9
Participant Details
Original Note:
Adverse events of special interest (AESI) are things that must be reported to the trial sponsor by the investigator immediately *IF* they occur even if not serious. The list is established before the trial and is mostly copied from previous trials. These are not side effects. https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf https://cioms.ch/publications/product/development-safety-update-report-dsur-harmonizing-format-content-periodic-safety-report-clinical-trials-report-cioms-working-group-vii/
All Note Details