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Main CRF (Follow-up)

1 forms  
  1. StudyEvent: ODM
    1. Main CRF (Follow-up)
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
Description

Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C0021822
UMLS CUI-4
C2347852
UMLS CUI-5
C0021822
UMLS CUI-7
C0877248
UMLS CUI-8
C0021822
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Investigator number
Description

Investigator Identifier

Data type

integer

Alias
UMLS CUI [1]
C2826689
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
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

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Is the subject aware of any forthcoming requirements?
Description

Compliance behavior limited

Data type

boolean

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

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Has the subject used any concomitant medications?
Description

If YES, record on CONCOMITANT MEDICATIONS page(s).

Data type

boolean

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

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0392747
Pregnancy Test Worksheet
Description

Pregnancy Test Worksheet

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Specimen collection

Data type

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0038577
Is a pregnancy test applicable?
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
If YES, was pregnancy test performed?
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Pregnancy test result, tick one
Description

If positive, complete PREGNANCY NOTIFICATION FORM.

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
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Similar models

Main CRF (Follow-up)

1 forms
  1. StudyEvent: ODM
    1. Main CRF (Follow-up)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Compliance Restrictions/ Concomitant Medications and Adverse Event Enquiry Worksheet
C1321605 (UMLS CUI-1)
C0021822 (UMLS CUI-2)
C2347852 (UMLS CUI-4)
C0021822 (UMLS CUI-5)
C0877248 (UMLS CUI-7)
C0021822 (UMLS CUI-8)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Compliance behavior
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
boolean
C1321605 (UMLS CUI [1])
Compliance behavior limited
Item
Is the subject aware of any forthcoming requirements?
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Concomitant medications
Item
Has the subject used any concomitant medications?
boolean
C2347852 (UMLS CUI [1])
Health status change
Item
Has there been any change in the state of the subject's health?
boolean
C0018759 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Item Group
Pregnancy Test Worksheet
C0032976 (UMLS CUI-1)
Specimen collection
Item
Date sample taken
date
C0200345 (UMLS CUI [1,1])
C0038577 (UMLS CUI [1,2])
pregnancy test
Item
Is a pregnancy test applicable?
boolean
C0032976 (UMLS CUI [1])
pregnancy test
Item
If YES, was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Item
Pregnancy test result, tick one
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test Result
Code List
Pregnancy test result, tick one
CL Item
negative (N)
CL Item
positive (P)
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