Examples of Edit Checks Demog: WEIGHT is outside expected rangeBody mass index is below expected ( CHECK weight and height) Age is not within expected range. DOB is greater than the Visit date or not.. Gender value is a VALID one or invalid. etc Adverse Event Stop is before the start or visit Start is before birthdate Study medicine discontinued due to adverse event but completion indicated (COMPLETE =1)

Labs Result is within the normal range but abnormal is not blank or ‘N’Result is outside the normal range but abnormal is blank

Vitals DIASTOLIC BP > Systolic BP

Medical History Visit date prior to Screen datePhysicalPhysical exam is normal but comment included

Examples of Edit Checks Demog: Weight is outside expected rangeBody mass index is below expected ( check weight and height) Age is not within expected range. DOB is greater than the Visit date or not.. Gender value is a valid one or invalid. etc Adverse Event Stop is before the start or visit Start is before birthdate Study medicine discontinued due to adverse event but completion indicated (COMPLETE =1)

Labs Result is within the normal range but abnormal is not blank or ‘N’Result is outside the normal range but abnormal is blank

Vitals Diastolic BP > Systolic BP

Medical History Visit date prior to Screen datePhysicalPhysical exam is normal but comment included