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Questions and Answers
When evaluating the causality of an adverse event, which of the following should be a consideration?
When evaluating the causality of an adverse event, which of the following should be a consideration?
- The patient's age
- Weather conditions at the time of the event
- The timing of the event in relation to administration of the investigational agent (correct)
- The diet of the subject
Accurate reporting of adverse events is most important for:
Accurate reporting of adverse events is most important for:
- Meeting study deadlines
- Improving drug efficacy
- Reducing study costs
- Ensuring subject safety (correct)
What should the investigator do when learning of a car crash involving a subject who sustained a broken wrist and mild concussion?
What should the investigator do when learning of a car crash involving a subject who sustained a broken wrist and mild concussion?
Report adverse events of both a broken wrist and a mild concussion.
Who should determine causality of the serious adverse event when a subject hospitalized for chest pain is enrolled in a phase I study?
Who should determine causality of the serious adverse event when a subject hospitalized for chest pain is enrolled in a phase I study?
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Study Notes
Evaluating Adverse Events
- Timing of an adverse event in relation to the administration of an investigational agent is crucial for causality assessment.
Importance of Reporting
- Accurate reporting of adverse events is essential for maintaining subject safety throughout clinical trials.
Incident Reporting
- In case a subject involved in a motor vehicle crash experiences a broken wrist and mild concussion, both injuries must be reported as adverse events.
Causality Determination
- For serious adverse events, such as a heart attack in a subject with a history of coronary artery disease, the Principal Investigator is responsible for determining causality.
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