All serious adverse events (SAEs) must be reported to the research site's Institutional Review Board (IRB).A. TRUEB. FALSE

Researchers must report potential unanticipated problems that involve risks to others directly to the: HIPAA Compliance Officer Institutional Risk Manager American Psychological Association Institutional Review Board (IRB)

Who can report an adverse event (AE)?A. ParticipantB. Participant's spouseC. CaregiverD. Participant's family memberE. Research NurseF. All of the above can report an AE

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is limited to review of unanticipated problems. Is not required unless additional risks have been identified. Must occur within 12 months of the approval date. Must be conducted by a convened IRB.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is not required unless additional risks have been identified. Must be conducted by a convened IRB. Must occur within 12 months of the approval date. Is limited to review of unanticipated problems.

Examples of adverse events (AE) include which of the following?A. Damaged wheelchair.B. Anxiety.C. Decreased blood sodium.D. Enlarged thyroid on physical examination.E. B, C, and D onlyF. All the above are adverse events (AEs).