1. StudyEvent: ODM
    1. Follow-Up
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
URINE PREGNANCY TEST (Females only)
Beschreibung

URINE PREGNANCY TEST (Females only)

Alias
UMLS CUI-1
C0430056
Was a pregnancy test carried out?
Beschreibung

Urine Pregnancy Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0430056
If 'No', please specify reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0430056
Date and Time of pregnancy test:
Beschreibung

Date Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0430057
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
Beschreibung

Result

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0430057
Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology
Beschreibung

Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Beschreibung

Date | Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005834
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
Comments
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
Beschreibung

Abnormal Findings

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2826633
UMLS CUI [2,1]
C0474523
UMLS CUI [2,2]
C2826633
Ensure a urine sample has been taken for urinalysis
Beschreibung

Ensure a urine sample has been taken for urinalysis

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling
Beschreibung

Date | Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0200354
UMLS CUI [2,2]
C0040223
Comments
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
Beschreibung

Abnormal findings

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2826633

Ähnliche Modelle

Follow-Up

  1. StudyEvent: ODM
    1. Follow-Up
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
URINE PREGNANCY TEST (Females only)
C0430056 (UMLS CUI-1)
Urine Pregnancy Test
Item
Was a pregnancy test carried out?
boolean
C0430056 (UMLS CUI [1])
Reason
Item
If 'No', please specify reason
text
C0430056 (UMLS CUI [1])
Date Time
Item
Date and Time of pregnancy test:
datetime
C0011008 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Result
Item
If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
boolean
C1274040 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Item Group
Clinical Chemistry and Haematology ensure a blood sample has been taken tor clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date | Time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal Findings
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
boolean
C0008000 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])
C0474523 (UMLS CUI [2,1])
C2826633 (UMLS CUI [2,2])
Item Group
Ensure a urine sample has been taken for urinalysis
C0042014 (UMLS CUI-1)
Date | Time
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200354 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Abnormal findings
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Adverse Event page.
boolean
C0042014 (UMLS CUI [1,1])
C2826633 (UMLS CUI [1,2])