Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026?
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026?
boolean
Total number of SAEs for the Malaria 039 period only
Item
Specify total number of SAEs for the Malaria 039 period only
integer
Is the subject withdrawn from the study?
Item
Is the subject withdrawn from the study?
boolean
Item
Major reason for withdrawal
text
Code List
Major reason for withdrawal
CL Item
Serious adverse event (2)
CL Item
Protocol violation (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)
In case of death, please specify SAE number
Item
In case of death, please specify SAE number
integer
In case of serious adverse event, specify SAE number
Item
In case of serious adverse event, specify SAE number
integer
In case of protocol violation, specify
Item
In case of protocol violation, specify
text
In other cases, specify
Item
In other cases, specify
text
Item
Who made the decision
text
Code List
Who made the decision
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
Item
Was the subject in good condition at date of last contact?
text
Code List
Was the subject in good condition at date of last contact?
CL Item
No -> If No, please give details in Adverse Events section (2)
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.
Item
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.
date
Investigator's signature
Item
Investigator's signature
text
Investigator's name (in print)
Item
Investigator's name (in print)
text