IRB, IC, AEs, Safety Monitoring
Fact review on Research IRB, IC, AEs and Safety Monitoring
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Topics of this game:
- What is the definition of an Adverse Event?
- Which of the follow is considered a strategy for deciding if an incident is an Adverse Event?
- True or False,: The FDA requires an investigator to report "Serious Adverse Events" to the sponsor within 24 hours
- The sponsor is required to report unexpected, serious, adverse reactions, events that are fatal or life threatening to the FDA in what time frame?
- Which of the following is not an investigator responsibility?
- Which of the following is true about pregnancies as they relate to adverse events
- Unresolved adverse events are followed for how long?
- Which of the following statements about Device adverse events are true?
- According to 21CFR part 56 Subpart D the IRB must maintain adequate documentation of their activities in what way?
- What statement is true about continuing review?
- According to 21CFR Part 50.25 what elements are required in an Informed Consent?
- Which statement is true about an Informed Consent short form?
- True or False: The only signature required on a regular Informed Consent form is that of the subjects?
- Which of the following states about patient understanding of the Informed Consent is false?
- Which of the following states is true about patient understanding of Informed Consent
- What is the definition of assent verses consent?
- Which of the follow is not a function of the IRB?
- Which of the follow is a requirement of the IRB?
- Which of the following statements is false?
- True or False: IRB Accreditation and Registration are the same thing.
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