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

Mandatory elements in the definition of an adverse event (AE) include which of the following?A. Untoward medical occurrence.B. Use of pharmaceutical product or a study intervention.C. Patient or clinical investigation subject involvement.D. Causal relationship with the pharmaceutical product.E. A, B, and C onlyF. All of the above.

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).

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

Question 1A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Report the adverse drug experience to the IRB only if there are several other occurrences. Report the adverse drug experience as part of the continuing review report. Do not report the adverse drug experience to the IRB since it is a common adverse experience.Question 2How long is an investigator required to keep consent documents, IRB correspondence, and research records? As long as the investigator is at that institution Until data analysis is complete Until the study is closed For a minimum of three years after completion of the studyQuestion 3According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study is required for a student research project The study does not require informed consent or survey instruments. The study includes only research subjects that are healthy volunteers. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulationsQuestion 4Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: The changes must be immediately implemented for the health and well-being of the subject. They only involve changes to the consent form. They are eligible for review using expedited procedures. The investigator keeps careful records of all changes and includes them in the final report.Question 5IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: Include copies of all signed consent forms. Be conducted by an expedited review. Occur only when the level of risk changes. Occur at least annually.

Who is responsible for reporting Incidents and Accidents?