1The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants

Answers 2

Answer: File it in regulatory binder

Report to local IRB and Inform all participants.

Explanation:

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Quick Answer: The site investigator should review the expedited safety report and take any necessary action to protect the safety of the study participants. Full Explanation: When a site investigator receives an expedited safety report, it is important that they review the report carefully and take any action necessary to protect the safety of the study participants. Depending on the nature of the report, this may include informing the sponsor and the local ethics committee about the issue, taking action to reduce or eliminate the risks identified in the report, or suspending the study if needed. Additionally, the investigator should ensure that all study participants are aware of any changes or adjustments to the study protocol and that any additional monitoring or assessments are completed as required.
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