Visit 4

  1. StudyEvent: ODM
    1. Visit 4
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation Status, Clinical Trials
Item
Did the subject return for visit 4?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (3)
Continuation Status, Clinical Trials, Reason
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory Tests - Blood Sample
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken ?
text
C0005834 (UMLS CUI [1])
Code List
Has a blood sample been taken ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (other half of the subjects of each group) (3)
Collection of blood specimen for laboratory procedure, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

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