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Visit Documentation 10

1 Formulare  
  1. StudyEvent: ODM
    1. Visit Documentation 10
Date and Type of Visit
Beschreibung

Date and Type of Visit

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

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

text

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

Date of Visit/Assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beschreibung

Time of Visit

Datentyp

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beschreibung

Cohort

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beschreibung

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

Datentyp

integer

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

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Beschreibung

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day 9, 15, 16, 17, 23, 24: 12-lead ECG

Datentyp

integer

Alias
UMLS CUI [1]
C1623258
Time from last dose of investigational product until ECG
Beschreibung

Time from last dose of investigational product until ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Start Date ECG
Beschreibung

Start Date ECG

Datentyp

date

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

Start Time ECG

Datentyp

time

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

Stop Date ECG

Datentyp

date

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

Stop Time ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Beschreibung

Date of dose

Datentyp

date

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

Time of dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Pharmacokinetics Blood
Beschreibung

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Time from last dose of investigational product until Clinical Chemistry measurement
Beschreibung

Time from last dose of investigational product until Clinical Chemistry measurement

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Actual Time of Pharmacokinetics Blood
Beschreibung

Actual Time of Pharmacokinetics Blood

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Visit Documentation 10

1 Formulare
  1. StudyEvent: ODM
    1. Visit Documentation 10
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 9 (1)
CL Item
Cohort 1-4 RD Day 15 (2)
CL Item
Cohort 1-4 RD Day 16 (3)
CL Item
Cohort 1-4 RD Day 17 (4)
CL Item
Cohort 1-4 RD Day 23 (5)
CL Item
Cohort 1-4 RD Day 24 (6)
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)
Item
Time from last dose of investigational product until ECG
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Time from last dose of investigational product until ECG
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
1h (4)
CL Item
2h (5)
CL Item
4h (6)
CL Item
8h (7)
CL Item
12h (8)
CL Item
24h (9)
CL Item
36h (10)
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 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])
Item Group
Pharmacokinetics Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Time from last dose of investigational product until Clinical Chemistry measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Timepoint of Laboratory Procedure
Code List
Time from last dose of investigational product until Clinical Chemistry measurement
CL Item
Predose (1)
Actual Time of Pharmacokinetics Blood
Item
Actual Time of Pharmacokinetics Blood
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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