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If a subject experiences a serious adverse event related to the study drug and only...

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If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:

A.

IRB/IEC immediately, then sponsor when full details are available

B.

Sponsor and IRB/IEC immediately, then update later

C.

Sponsor and IRB/IEC within five days

D.

Sponsor and IRB/IEC within seven days

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