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Visit Documentation 6

1 Formulär  
  1. StudyEvent: ODM
    1. Visit Documentation 6
Date and Type of Visit
Beskrivning

Date and Type of Visit

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C3641100
UMLS CUI-3
C0008976
Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beskrivning

Time of Visit

Datatyp

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beskrivning

Cohort

Datatyp

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beskrivning

Please choose the type of visit/form you would like to answer, for example Cohort 1-4 SD Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
ECG
Beskrivning

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Beskrivning

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day 3: 12-lead-ECG

Datatyp

integer

Alias
UMLS CUI [1]
C1623258
Start Date ECG
Beskrivning

Start Date ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start Time ECG
Beskrivning

Start Time ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
Stop Date ECG
Beskrivning

Stop Date ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
Stop Time ECG
Beskrivning

Stop Time ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
If Holter ECG, please select duration of ECG recording
Beskrivning

Duration of ECG recording

Datatyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0449238
Clinical Chemistry
Beskrivning

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date and time sample taken
Beskrivning

Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Has the subject fasted?
Beskrivning

Fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Beskrivning

Please answer the following questions for each Clinical Chemistry Analyte

Datatyp

integer

Alias
UMLS CUI [1]
C0008000
Clinical Chemistry, type of result
Beskrivning

Type of result

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Clinical Chemistry Numeric Result (if Numeric Result)
Beskrivning

Clinical Chemistry Numeric Result

Datatyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical Chemistry Character Result (if Character Result)
Beskrivning

Clinical Chemistry Character Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Questionnaires
Beskrivning

Questionnaires

Alias
UMLS CUI-1
C0034394
Simpson Angus Scale Score
Beskrivning

Please fill out 3h after dosing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0015371
UMLS CUI [1,3]
C0681889
The Barnes Akathisia Scale Score
Beskrivning

The Barnes Akathisia Scale Score

Datatyp

integer

Alias
UMLS CUI [1]
C3541345
Abnormal Involuntary Movement Scale Score
Beskrivning

Abnormal Involuntary Movement Scale Score

Datatyp

integer

Alias
UMLS CUI [1]
C0450978
Profile of Mood States
Beskrivning

Profile of Mood States

Datatyp

text

Alias
UMLS CUI [1]
C0451394
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Beskrivning

Date of dose

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of dose
Beskrivning

Time of dose

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
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Similar models

Visit Documentation 6

1 Formulär
  1. StudyEvent: ODM
    1. Visit Documentation 6
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date and Type of Visit
C1320303 (UMLS CUI-1)
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Time of Visit
Item
Time of Visit
time
C1320304 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
CL Item
PET (5)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
Cohort 1-4 RD Day 3 (1)
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Type of ECG
integer
C1623258 (UMLS CUI [1])
Type of ECG
Code List
Type of ECG
CL Item
12 lead ECG (1)
CL Item
Holter ECG (2)
CL Item
Telemetry ECG (3)
Start Date ECG
Item
Start Date ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time ECG
Item
Start Time ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date ECG
Item
Stop Date ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time ECG
Item
Stop Time ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
If Holter ECG, please select duration of ECG recording
integer
C1623258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of ECG recording
Code List
If Holter ECG, please select duration of ECG recording
CL Item
0-24hrs (1)
CL Item
0-48hrs (2)
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Clinical Chemistry Analytes
integer
C0008000 (UMLS CUI [1])
Clinical Chemistry Analytes
Code List
Clinical Chemistry Analytes
CL Item
ALT (1)
C0201850 (UMLS CUI-1)
(Comment:en)
CL Item
AST (2)
C0201836 (UMLS CUI-1)
(Comment:en)
CL Item
Total Bilirubin (3)
C0201913 (UMLS CUI-1)
(Comment:en)
CL Item
Direct Bilirubin  (4)
C0201916 (UMLS CUI-1)
(Comment:en)
CL Item
Glucose (5)
C0337438 (UMLS CUI-1)
(Comment:en)
CL Item
GGT (6)
C0202035 (UMLS CUI-1)
(Comment:en)
CL Item
Total Protein  (7)
C0555903 (UMLS CUI-1)
(Comment:en)
CL Item
Albumin (8)
C0201838 (UMLS CUI-1)
(Comment:en)
CL Item
Potassium (9)
C0202194 (UMLS CUI-1)
(Comment:en)
CL Item
Sodium (10)
C0337443 (UMLS CUI-1)
(Comment:en)
CL Item
Chloride (11)
C0201952 (UMLS CUI-1)
(Comment:en)
CL Item
Urea (12)
C0523961 (UMLS CUI-1)
(Comment:en)
CL Item
Creatinine (13)
C0201975 (UMLS CUI-1)
(Comment:en)
CL Item
Calcium (14)
C0201925 (UMLS CUI-1)
(Comment:en)
CL Item
Bicarbonate (15)
C0202059 (UMLS CUI-1)
(Comment:en)
CL Item
Tryglyceride (16)
C0202236 (UMLS CUI-1)
(Comment:en)
CL Item
Cholesterol (17)
C0201950 (UMLS CUI-1)
(Comment:en)
CL Item
LDL (18)
C0428474 (UMLS CUI-1)
(Comment:en)
CL Item
HDL (19)
C0428472 (UMLS CUI-1)
(Comment:en)
CL Item
Uric Acid  (20)
C0202239 (UMLS CUI-1)
(Comment:en)
CL Item
Alkaline Phosphatase  (21)
C0201850 (UMLS CUI-1)
(Comment:en)
Item
Clinical Chemistry, type of result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Clinical Chemistry, type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Clinical Chemistry Numeric Result
Item
Clinical Chemistry Numeric Result (if Numeric Result)
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical Chemistry Character Result
Item
Clinical Chemistry Character Result (if Character Result)
text
C0008000 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Questionnaires
C0034394 (UMLS CUI-1)
Simpson Angus Scale Score
Item
Simpson Angus Scale Score
integer
C0041755 (UMLS CUI [1,1])
C0015371 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
The Barnes Akathisia Scale Score
Item
The Barnes Akathisia Scale Score
integer
C3541345 (UMLS CUI [1])
Abnormal Involuntary Movement Scale Score
Item
Abnormal Involuntary Movement Scale Score
integer
C0450978 (UMLS CUI [1])
Profile of Mood States
Item
Profile of Mood States
text
C0451394 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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