Good Clinical Practice Guide
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Thread: Adverse event before dosing

  1. #1

    Adverse event before dosing

    Dear all,
    We have one case in which subject has abnormal blood pressure before dosing of period-1. So this subject was not dosed. Is it require to open adverse event for this subject and report it in the final report? or is it ok if we mention (in subject screening record) that this subject didn't meet pre-dosing requirement and was withdrawn.
    kindly let me know your thoughts.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    168
    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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