Investigational Product, Treatment Confirmation, Randomisation-Number

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
integer
C3641100 (UMLS CUI [1])
Code List
Visit Type
CL Item
Day 1 of Period 1 (1)
CL Item
Day 1 of Period 2 (2)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Treatment confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Reason for Treatment modification
Item
If No, record reason(s)
text
C2736765 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item Group
Randomisation number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation number
Item
Record randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

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