Study Conclusion
Date last contact
date
If no: Date of last contact must match the last scheduled study visit date. If yes: complete details. 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.
boolean
if applicable
date
if 1 = Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. if 7 = Investigator discretion, specify in next question. Select this reason if none of the other primary reasons are appropriate.
integer
if applicable
text
Data owner should check the box when data cleaning is complete
boolean
Office Use 1 [hidden]
boolean
Office Use 2 [hidden]
integer
Status of Treatment Blind
If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate, and additional questions in this form.
boolean
if applicable
datetime
if applicable If other, please specify
integer
if applicable
text
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
Electronic Signature
By my dated signature below, I [investigator first and last name] verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.
text
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
date