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Laboratory Data (All Part A Visits)

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Beskrivning

Form needs to be filled out on each attended visit mentioned below.

Datatyp

text

Alias
UMLS CUI [1]
C0545082
Electronically transferred Laboratory Data
Beskrivning

Electronically transferred Laboratory Data

Alias
UMLS CUI-1
C1705214
Relative Time for Sessions 1 and 2
Beskrivning

Question only relevant for Session visits. Pre-dose and 2 hrs post-dose general Laboratory data, other relative times haematology, clinical chemistry and urinalysis. 72 hrs post-dose only necessary if 48 hrs post-dose assessments are abnormal.

Datatyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0022885
Type of Laboratory Data
Beskrivning

General/Unspecified: only to be chosen for Session 1/2 Day 1, pre-dose and 2 hrs post-dose. All other Session timepoints as well as all other visits need Clinical Chemistry, Haematology and Urinalysis.

Datatyp

text

Alias
UMLS CUI [1]
C0022885
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time sample taken
Beskrivning

Time sample taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
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Similar models

Laboratory Data (All Part A Visits)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit
Code List
Subject Identifier
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit
Code List
Visit Type
CL Item
Screening (Screening)
CL Item
Session 1 (Session 1)
CL Item
Session 2 (Session 2)
CL Item
Follow-Up (Follow-Up)
CL Item
Early Withdrawal (Early Withdrawal)
Item Group
Electronically transferred Laboratory Data
C1705214 (UMLS CUI-1)
Item
Relative Time for Sessions 1 and 2
text
C0439564 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Relative Time
Code List
Relative Time for Sessions 1 and 2
CL Item
Day -1 (Day -1)
CL Item
Day 1, Pre-dose (Day 1, Pre-dose)
CL Item
Day 1, 2 hrs post-dose (Day 1, 2 hrs post-dose)
CL Item
Day 1, 24 hrs post-dose (Day 1, 24 hrs post-dose)
CL Item
Day 1, 48 hrs post-dose (Day 1, 48 hrs post-dose)
CL Item
Day 1, 72 hrs post-dose (Day 1, 72 hrs post-dose)
Item
Type of Laboratory Data
text
C0022885 (UMLS CUI [1])
Type of Laboratory Data
Code List
Type of Laboratory Data
CL Item
General/Unspecified (General/Unspecified)
CL Item
Haematology (Haematology)
CL Item
Clinical Chemistry (Clinical Chemistry)
CL Item
Urinalysis (Urinalysis)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
Actual Time sample taken
text
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
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