I assume that the subject has signed a consent form and is therefore a participant in the trial (will be screened, etc, etc). Adverse Event (as per ICH GCP E6 R2) is not an adverse reaction and should be recorded as an AE.
I assume that the subject has signed a consent form and is therefore a participant in the trial (will be screened, etc, etc). Adverse Event (as per ICH GCP E6 R2) is not an adverse reaction and should be recorded as an AE.
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