Engelsk

Laboratory Tests

1 Formulär  
  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beskrivning

Country No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Centre No.
Beskrivning

Centre No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject No.
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beskrivning

During Screening (Visit 0) only.

Datatyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of Visit
Beskrivning

For Visit 0: No more than 7 days before Day 1 (48 hours if pregnancy test needed)

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

For Visit 0: Fill in Pregnancy Test (if applicable), Haematology and Biochemistry. For Visit 1 (Day 1): Fill in Haematology only. For Visit 2 Day 3: Not applicable if treatment stopped within the last 24 hours -> then use "Visit 2 Day 9 or End of Treatment" instead. Fill in Haematology and Biochemistry. For Visit 2 Day 9 / End of Treatment: Fill in Haematology and Biochemistry. For Visit 3: Only to be used if bleeding has occured, and only Haematology test is performed.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pregnancy Test
Beskrivning

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test done?
Beskrivning

Pregnancy Test done?

Datatyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0884358
Pregnancy Test: Date of sampling
Beskrivning

Visit 0 (Screening) only, less than 48 hours before Surgery.

Datatyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy Test: Time of sampling
Beskrivning

Pregnancy Test: Time of sampling

Datatyp

time

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Pregnancy Test: Result
Beskrivning

Pregnancy Test: Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Haematology - Administrative Data
Beskrivning

Haematology - Administrative Data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C1320722
Not Done? Same laboratory as before?
Beskrivning

Select only one option. If performed but different name/city, give details in next item. This item is not applicable at Visit 0.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1272696
UMLS CUI [2,1]
C3258037
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C1882331
UMLS CUI [3,2]
C0008848
UMLS CUI [3,3]
C0442739
Laboratory Name/City
Beskrivning

Laboratory Name/City

Datatyp

text

Alias
UMLS CUI [1]
C3258037
UMLS CUI [2,1]
C1882331
UMLS CUI [2,2]
C0008848
Haematology Date of Sampling
Beskrivning

Haematology Date of Sampling

Datatyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology Time of Sampling
Beskrivning

Haematology Time of Sampling

Datatyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0018941
Haematology - Results
Beskrivning

Haematology - Results

Alias
UMLS CUI-1
C0018941
UMLS CUI-2
C1254595
Select Haematology Test
Beskrivning

Fill in entire itemgroup once per test. At Visits 0, 1 and 2 (Day 3 and 9, as applicable), both tests are to be performed. If a haematology test is to be performed at Visit 3, only hemoglobin is tested.

Datatyp

text

Alias
UMLS CUI [1]
C0018941
Haematology Test done?
Beskrivning

Haematology Test done?

Datatyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0884358
Haematology Test Value
Beskrivning

Haematology Test Value

Datatyp

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Haematology Test Unit
Beskrivning

If other unit is used, specify in next item

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1519795
If other unit, specify
Beskrivning

Specify Other Haematology Test Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1519795
Biochemistry - Administrative Data
Beskrivning

Biochemistry - Administrative Data

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C0005477
Same laboratory as above
Beskrivning

If no, give details in next item

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0442739
UMLS CUI [2,1]
C1882331
UMLS CUI [2,2]
C0008848
UMLS CUI [2,3]
C0442739
Laboratory Name/City
Beskrivning

Laboratory Name/City

Datatyp

text

Alias
UMLS CUI [1]
C3258037
UMLS CUI [2,1]
C1882331
UMLS CUI [2,2]
C0008848
Biochemistry Date of Sampling
Beskrivning

Biochemistry Date of Sampling

Datatyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0005477
Biochemistry Time of Sampling
Beskrivning

Biochemistry Time of Sampling

Datatyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0005477
Biochemistry - Results
Beskrivning

Biochemistry - Results

Alias
UMLS CUI-1
C0005477
UMLS CUI-2
C1254595
Select Biochemistry Test
Beskrivning

At Visit 0, all three tests are to be performed. At Visit 2 Day 3, only Creatinine is tested. At Visit 2 Day 9 or End of Treatment, only ASAT and ALAT are tested. Biochemistry Tests are not performed at Visit 1 or 3.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
Biochemistry Test done?
Beskrivning

Biochemistry Test done?

Datatyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0884358
Biochemistry Test Value
Beskrivning

Biochemistry Test Value

Datatyp

float

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1274040
Biochemistry Test Unit
Beskrivning

If other unit is used, specify in next item

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1519795
If other unit, specify
Beskrivning

Specify Other Biochemistry Test Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C0005477
UMLS CUI [1,3]
C0022885
UMLS CUI [1,4]
C1519795
Unscheduled Laboratory Tests
Beskrivning

Unscheduled Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
Laboratory Test
Beskrivning

Laboratory Test

Datatyp

text

Alias
UMLS CUI [1]
C0022885
Date and Time of Sampling
Beskrivning

Date and Time of Sampling

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1264639
Laboratory Test Value
Beskrivning

Laboratory Test Value

Datatyp

float

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0022885
Laboratory Test Unit
Beskrivning

Laboratory Test Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Laboratory Test: Normal range lower limit
Beskrivning

Laboratory Test: Normal range lower limit

Datatyp

float

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1272773
Laboratory Test: Normal range upper limit
Beskrivning

Laboratory Test: Normal range upper limit

Datatyp

float

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1299400
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Similar models

Laboratory Tests

1 Formulär
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 0 (Screening / pre-operative) (1)
CL Item
Visit 1 (Day 1 / post-operative: Prior to first post-operative injection) (2)
CL Item
Visit 2 (Day 3) (3)
CL Item
Visit 2 (Day 9 or End of Treatment: less than 24 hours from last dose) (4)
CL Item
Visit 3 (Follow-Up) (5)
CL Item
Unscheduled Test (6)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Pregnancy Test done?
text
C0032976 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Pregnancy Test done?
Code List
Pregnancy Test done?
CL Item
Done (D)
CL Item
Not Applicable/Not Done (NA)
Pregnancy Test: Date of sampling
Item
Pregnancy Test: Date of sampling
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pregnancy Test: Time of sampling
Item
Pregnancy Test: Time of sampling
time
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Pregnancy Test: Result
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test: Result
Code List
Pregnancy Test: Result
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Haematology - Administrative Data
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Not Done? Same laboratory as before?
integer
C0022885 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C3258037 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C1882331 (UMLS CUI [3,1])
C0008848 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Test performed? Laboratory Name/City same as before?
Code List
Not Done? Same laboratory as before?
CL Item
Not done (option not available at Visit 0/Screening) (1)
CL Item
Same laboratory as before (2)
CL Item
Laboratory Name/City different (specify) (3)
Laboratory Name/City
Item
Laboratory Name/City
text
C3258037 (UMLS CUI [1])
C1882331 (UMLS CUI [2,1])
C0008848 (UMLS CUI [2,2])
Haematology Date of Sampling
Item
Haematology Date of Sampling
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology Time of Sampling
Item
Haematology Time of Sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Item Group
Haematology - Results
C0018941 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
Item
Select Haematology Test
text
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Select Haematology Test
CL Item
Platelet (1)
CL Item
Hemoglobin (2)
Item
Haematology Test done?
text
C0018941 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Haematology Test
Code List
Haematology Test done?
CL Item
not done (MD)
CL Item
done (D)
Haematology Test Value
Item
Haematology Test Value
float
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Haematology Test Unit
integer
C0018941 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Haematology Test Unit
Code List
Haematology Test Unit
CL Item
10^9/L (for Platelets) (1)
CL Item
g/dL (for Hemoglobin) (2)
CL Item
Other unit (3)
Specify Other Haematology Test Unit
Item
If other unit, specify
text
C3845569 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Item Group
Biochemistry - Administrative Data
C1320722 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
Laboratory Name/City same as before
Item
Same laboratory as above
boolean
C3258037 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C1882331 (UMLS CUI [2,1])
C0008848 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
Laboratory Name/City
Item
Laboratory Name/City
text
C3258037 (UMLS CUI [1])
C1882331 (UMLS CUI [2,1])
C0008848 (UMLS CUI [2,2])
Biochemistry Date of Sampling
Item
Biochemistry Date of Sampling
date
C1302413 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
Biochemistry Time of Sampling
Item
Biochemistry Time of Sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,3])
Item Group
Biochemistry - Results
C0005477 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
Item
Select Biochemistry Test
integer
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Haematology Test
Code List
Select Biochemistry Test
CL Item
Creatinine (1)
CL Item
ASAT (2)
CL Item
ALAT (3)
Item
Biochemistry Test done?
text
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Haematology Test
Code List
Biochemistry Test done?
CL Item
not done (MD)
CL Item
done (D)
Biochemistry Test Value
Item
Biochemistry Test Value
float
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Biochemistry Test Unit
integer
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Haematology Test Unit
Code List
Biochemistry Test Unit
CL Item
mg/dL (for Creatinine) (1)
CL Item
UL (for ASAT and ALAT) (2)
CL Item
Other unit (3)
Specify Other Biochemistry Test Unit
Item
If other unit, specify
text
C3845569 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Item Group
Unscheduled Laboratory Tests
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Laboratory Test
Item
Laboratory Test
text
C0022885 (UMLS CUI [1])
Date and Time of Sampling
Item
Date and Time of Sampling
datetime
C0005834 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Laboratory Test Value
Item
Laboratory Test Value
float
C1254595 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Laboratory Test Unit
Item
Laboratory Test Unit
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Laboratory Test: Normal range lower limit
Item
Laboratory Test: Normal range lower limit
float
C0022885 (UMLS CUI [1,1])
C1272773 (UMLS CUI [1,2])
Laboratory Test: Normal range upper limit
Item
Laboratory Test: Normal range upper limit
float
C0022885 (UMLS CUI [1,1])
C1299400 (UMLS CUI [1,2])
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