Follow-up studies
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1])
Item
If you answered the previous question with 'No', please specify the reason:
integer
C0016441 (UMLS CUI [1])
Code List
If you answered the previous question with 'No', please specify the reason:
CL Item
Adverse Events, or Serious Adverse Events: please specify: --------------------------------------------------------------- (1)
CL Item
<Other: please specify: --------------------------------------------------------------- (2)
Item
Has the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Code List
Has the subject become pregnant during the study?
CL Item
Yes, please compete the Pregnancy Report Form. (2)
Item
Did any elimination criteria become applicable during the study?
integer
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Code List
Did any elimination criteria become applicable during the study?
CL Item
Yes, please specify: _____________________________________________________________________ (2)
Drop out
Item
Has the subject dropped out of the study? (a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
boolean
C2348568 (UMLS CUI [1])
Item
If you answered the previous question with Yes, please mark the ONE most appropriate category for drop out.
text
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
If you answered the previous question with Yes, please mark the ONE most appropriate category for drop out.
CL Item
Serious adverse event (complete the Serious Adverse Event form). ((SAE))
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event form). Please specify AE N°: ___________________________________________________________ ((AEX))
CL Item
Protocol violation, please specify:__________________________________________________ ((PTV))
CL Item
Consent withdrawal, not due to an adverse event. ((CWS))
CL Item
Migrated / moved from the study area ((MIG))
CL Item
Lost to follow-up. ((LFU))
CL Item
Other, please specify: ____________________________________________________________ ((OTH))
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (1)
Signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])