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.
text
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.
integer
Subject withdrawal, Investigator discretion
text
In the original form this item is hidden. Data owner should check the box when data cleaning is complete
boolean
In the original form this item is hidden.
text
In the original form this item is hidden.
integer
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.
text
Case book signature
investigator first name
text
investigator last name
text
Signature date
date
electronic signature
text