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An investigator received an updated informed consent form (ICF) from the sponsor for a study...

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An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?

A.

Sub-investigators

B.

Participants in long-term follow-up

C.

The IRB/IEC

D.

No notification is required

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