Status of treatment blind
If Yes, complete the following items.
text
day month year
date
00:00-23:59
time
Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.
integer
Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.
text
Study conclusion
day month year. If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" 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.
date
Withdrawn from study
text
If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.
integer
Other reason for withdrawl
text
Pregnancy information
Investigator Comment Log
Investigator's signature
day month year
date
"I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below."
text
Investigator's name
text