Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Screening
Item
Date of Screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item
Did the subject experience any Serious Adverse Event during screening?
text
C1519255 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Code List
Did the subject experience any Serious Adverse Event during screening?
SAE Number during screening
Item
If subject experienced any SAE during sceening period, please specify total number of SAEs.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Item
Is the subject a screening failure?
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Code List
Is the subject a screening failure?
Item
If the subject was a screening failure, please tick the major reason for failure
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Code List
If the subject was a screening failure, please tick the major reason for failure
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria) (ELI)
CL Item
Protocol violation (PTV)
CL Item
Serious adverse event (SAE)
CL Item
Consent withdrawal not due to a serious adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
Reason for failure in screening, specification
Item
Reason for failure in screening, specification
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Item
Who made the decision?
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,4])
Code List
Who made the decision?
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])