Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used? Who can report an a... Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used? Who can report an adverse event (AE)? A participant missed several study visits and the research site staff becomes aware of a participant's death searching through public records. What is the most appropriate next course of action? For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct? Site staff should report an unexpected serious adverse event (SAE) to the Sponsor within _______ after becoming aware of the event.
Understand the Problem
The questions are centered around the reporting and management of adverse events in clinical studies involving investigational new drugs. They seek to clarify which documents can be used to determine the nature of adverse events, who is eligible to report them, and the appropriate actions to take in specific scenarios regarding participant safety and compliance with study protocols.
Answer
Annual Safety Report may not be used.
The Annual Safety Report may not be used to determine whether an adverse event is expected or not in clinical studies involving an investigational new drug.
Answer for screen readers
The Annual Safety Report may not be used to determine whether an adverse event is expected or not in clinical studies involving an investigational new drug.
More Information
The Annual Safety Report is typically a compilation of multi-study data meant for regulatory purposes and may not specify shared adverse event expectations.
Sources
- Solved Which source document may NOT be used? - chegg.com
- Brainly - Which source document may NOT be used? - brainly.in
AI-generated content may contain errors. Please verify critical information
