If study participant is screened, up to how many days the medical history, physical examination (lab reports-ray reports, etc,) can be considered as valid?
CHP – This time duration would be in the protocol. This said, the answer lies in the nature of the study medication and the risk: benefit ratio. For some studies I would want to conduct the study in days (maybe up to 10 days) after the screening safety information. When I was a PI, I would require a repeat of critical safety data after two weeks but I would not require a repeat physical exam or BP for example (unless a BP is critical or a certain cut-off BP is an I/E requirement.
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