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PK Blood Sample

1 forms  
  1. StudyEvent: ODM
    1. PK Blood Sample
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date and time
Description

Dosing date and time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Infusion start date/time
Description

[read-only]

Data type

datetime

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C1264639
Infusion stop date/time
Description

[read-only]

Data type

datetime

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C1264639
PK Blood Sample (Pre and Post Dose)
Description

PK Blood Sample (Pre and Post Dose)

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
Time relative to infusion
Description

For both cycles collect a sample for all timepoints herein in week 1 and 4, pre-infusion only in week 2 and 3. For the cycles' observation samples and "any time" samples this item is not needed.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0031328
UMLS CUI [1,5]
C0005834
Sample taken
Description

pharmacokinetics sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If yes, complete details, start date and actual start time
Description

Pre infusion, sample taken, start date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1264639
If yes, complete details, sample identifier
Description

Pre infusion, sample taken, sample identifier

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1299222
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Similar models

PK Blood Sample

1 forms
  1. StudyEvent: ODM
    1. PK Blood Sample
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Cycle 1 week 1 (1)
CL Item
Cycle 1 week 2 (2)
CL Item
Cycle 1 week 3 (3)
CL Item
Cycle 1 week 4 (4)
CL Item
Cycle 1 Observation visit (5)
CL Item
Cycle 2 week 1 (6)
CL Item
Cycle 2 week 2 (7)
CL Item
Cycle 2 week 3 (8)
CL Item
Cycle 2 week 4 (9)
CL Item
Cycle 2 observation visit (10)
CL Item
unscheduled visit (11)
Item Group
Dosing date and time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Infusion start date/time
Item
Infusion start date/time
datetime
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Infusion stop date/time
Item
Infusion stop date/time
datetime
C0574032 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
PK Blood Sample (Pre and Post Dose)
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
Time relative to infusion
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
Time relative to dosing
Code List
Time relative to infusion
CL Item
Pre-Infusion (1)
CL Item
End of infusion (2)
CL Item
1 hr post infusion (3)
pharmacokinetics sample taken
Item
Sample taken
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Pre infusion, sample taken, start date/time
Item
If yes, complete details, start date and actual start time
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Pre infusion, sample taken, sample identifier
Item
If yes, complete details, sample identifier
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
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