Participant safety is a fundamental principle of Good Clinical Practice. Participant safety is a fundamental principle of Good Clinical Practice.
Every adverse drug reaction is an AE, but not every AE is an ADR. Every adverse drug reaction is an AE, but not every AE is an ADR.
Who should determine relatedness of an AE to the study intervention? Who should determine relatedness of an AE to the study intervention?
A severe toothache may be severe but not serious if it does not meet SAE criteria. A severe toothache may be severe but not serious if it does not meet SAE criteria.
Suspected unanticipated problems involving risks should be promptly reported to the IRB/IEC. Suspected unanticipated problems involving risks should be promptly reported to the IRB/IEC.
