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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?
When can an IRB/IEC review a study using expedited review?
In accordance with the ICH GCP Guideline, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions?
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