Who reports adverse events (AEs) in ISR Program studies?
As part of good clinical practice (GCP) and as study sponsors, you should report AEs to the center IRB where the AE occurred and to Boston Scientific’s Technical Services at 1-800-CARDIAC. To learn about reporting to IRBs, refer to the documented processes for the particular IRB(s). Guidance from the FDA regarding AE reporting is available at www.fda.gov.
