Study conclusion
day month year If the subject completed the study: Date of last contact must match the last scheduled study visit date. If the subject withdrew: Date of decision to withdraw must match the date of decision to withdraw the subject from the study before normal completion. Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.
date
If you tick yes, complete the primary reason for withdrawal in the following item.
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If you tick adverse event, record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Only tick Investigator discretion if none of the other primary reasons are appropriate. If you tick Investigator discretion, please specify in the following item.
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Subject withdrawal, Investigator discretion
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In the original form this item is hidden. Data owner should check the box when data cleaning is complete
boolean
By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.
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In the original form this item is hidden.
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In the original form this item is hidden.
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Pregnancy information (female)
Pregnancy information (male)
If you tick yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.
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