SOCRA Certified Clinical Research Professional (CCRP)

In clinical research, an adverse event is considered 'unexpected' when it:

Occurs without the investigator present Is not listed in or is inconsistent with the risk information in the Investigator's Brochure Occurs outside of normal clinic hours Is not reported by the participant to the study team

Correct Answer:

Is not listed in or is inconsistent with the risk information in the Investigator's Brochure

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