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((Folder structure (Subject Folder (Screening Folder (Screening Visit,…
Folder structure
Subject Folder
Screening Folder
Screening Visit
Subject Demography
Infomed Consent
Relevant Medical History
Vital Signs Screening
Subject Randomisation
Subject Enrollment
Visits 1
Visits
Vital Signs
Visits 2
Visits
Vital Signs
Visits 3
Visits
Vital Signs
Visits 4
Visits
Vital Signs
Adverse Event Form
Early Termination
Visits
Subject Early Withdrawal
Death Details
Screening Failure
Subject screen failure
End Of Study
Visit
Subject Completion