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Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Screening, Treatment Period Number, Follow up
Description

Screening, Treatment Period Number, Follow up

Data type

text

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0237753
UMLS CUI [2,2]
C1948053
UMLS CUI [3]
C1522577
Compliance Restrictions
Description

Compliance Restrictions

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C2065135
Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
Description

Requirements compliance

Data type

text

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C2065135
Is the subject aware of any forthcoming requirements?
Description

Aware of forthcoming requirements

Data type

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Comments to compliance
Description

Comments

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1321605
Concomitant Medications and Adverse Event Enquiry
Description

Concomitant Medications and Adverse Event Enquiry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
Has the subject used any concomitant medications?
Description

If YES, record on CONCOMITANT MED/CATIONS page(s).

Data type

text

Alias
UMLS CUI [1]
C2347852
Has there been any change in the state of the subject's health?
Description

If YES record any adverse events as per protocol.

Data type

text

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
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Similar models

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Screening, Treatment Period Number, Follow up
text
C0220908 (UMLS CUI [1])
C0237753 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3])
Period Number
Code List
Screening, Treatment Period Number, Follow up
CL Item
Screening (1)
CL Item
Treatment Period 1 (2)
CL Item
Treatment Period 2 (3)
CL Item
Treatment Period 3 (4)
CL Item
Treatment Period 4 (5)
CL Item
Follow-up (FU)
CL Item
Treatment Period 5 (6)
Item Group
Compliance Restrictions
C1321605 (UMLS CUI-1)
C2065135 (UMLS CUI-2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
text
C0525058 (UMLS CUI [1,1])
C2065135 (UMLS CUI [1,2])
Requirements compliance
Code List
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is the subject aware of any forthcoming requirements?
text
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Aware of forthcoming requirements
Code List
Is the subject aware of any forthcoming requirements?
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments to compliance
text
C0947611 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
Concomitant Medications and Adverse Event Enquiry
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Has the subject used any concomitant medications?
text
C2347852 (UMLS CUI [1])
Concomitant medications
Code List
Has the subject used any concomitant medications?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has there been any change in the state of the subject's health?
text
C0018759 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Health state, change
Code List
Has there been any change in the state of the subject's health?
CL Item
Yes (Y)
CL Item
No (N)
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