Study Conclusion
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 yes, complete details
boolean
if applicable
date
Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. If Investigator discretion, specify in next question. Select this reason if none of the other primary reasons are appropriate.
text
if applicable
text
Data owner should check the box when data cleaning is complete
boolean
Office Use 1
boolean
Office Use 2
integer
Pregnancy Information (female)
Pregnancy Information (male)
If Yes, complete the paper Pregnancy Notification form Check "Not Applicable" if female partner not of childbearing potential or no female partner.
text
Status of Treatment Blind
If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate, and fill in the rest of this itemgroup.
boolean
if applicable
datetime
if applicable If other, please specify
text
if applicable
text