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When the investigator's causality assessment differs from the sponsor's (sponsor considers event related, investigator does not), how should the discrepancy be handled for regulatory reporting?

The investigator's assessment always overrides the sponsor's Both assessments should be reported, with the sponsor reporting based on the more conservative (related) assessment The event does not need to be reported if the investigator disagrees A data safety monitoring board must resolve all discrepancies before reporting

Correct Answer:

Both assessments should be reported, with the sponsor reporting based on the more conservative (related) assessment

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