Previous Subject Number
Item
Previous Subject Number
integer
Date of birth
Item
Date of birth
date
Item
Please document the reason for non-participation
text
Code List
Please document the reason for non-participation
CL Item
Subject not eligible? (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate (see reasons below) (3)
death date
Item
In case of death, please record the date
date
Item
If patient is not willing to participate, please choose the reason below:
text
Code List
If patient is not willing to participate, please choose the reason below:
CL Item
adverse events, or serious adverse event (1)
Specify reasons
Item
Please specify reasons mentioned above
text
failed eligibility criteria
Item
In case any eligibility criteria are not fulfilled, please specify them:
text
Date of Contact
Item
Date of Contact
date
Please record Investigator's name in print
Item
Please record Investigator's name in print
text
Signature
Item
Signature
text
Subject experienced any SAE?
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
If Yes, please specify the total number of SAE
Item
If Yes, please specify the total number of SAE
integer
treatment blind broken?
Item
Was the treatment blind broken during the study?
boolean
If Yes, please record the date
Item
If Yes, please record the date
date
Item
Tick one reason for unblinding
text
Code List
Tick one reason for unblinding
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
If Other, specify
Item
If Other, specify
text
subject withdrawal from study
Item
Was the subject withdrawn from the study?
boolean
Item
If Yes, please choose ONE most appropriate reason for withdrawal
text
Code List
If Yes, please choose ONE most appropriate reason for withdrawal
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious Adverse Event (2)
CL Item
Protocol violation, please specify (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
If Other specify
Item
If Other, please specify
text
If Protocol Violation specify
Item
In case of Protocol Violation, please specify
text
In case of SAEnumber
Item
In case of SAE, please record the SAE number
integer
If Non-SAE- number
Item
In case of Non-SAE, please record the Non-SAE number
integer
Item
Please tick who took decision
text
Code List
Please tick who took decision
CL Item
Parent/Guardian (2)
date of last contact
Item
Please record the date of last contact
date
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
Investigator's Confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself of my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's Signature
Item
Investigator's Signature
text
Printed Investigator's Name
Item
Printed Investigator's Name
text
Geen commentaren