Inglés

Investigational Product, Container Numbers, Randomisation

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Descripción

Date of Visit/Assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Descripción

Study site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Patient
Descripción

Patient

Tipo de datos

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Descripción

Subject No.

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Study Visit
Descripción

At all Visits, record Date/Time of Dose and Container Number 1. At Visit 4, record Randomisation information as well. At Visits 5 and 6, record the second Container Number.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
Date/time of dose
Descripción

Date/time of investigational product dose

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Investigational Product Container Number
Descripción

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational product container number
Descripción

Record the identifying number from the investigational product container dispensed at this visit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Investigational Product Container Number 2
Descripción

Investigational Product Container Number 2

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational product container number
Descripción

Applicable to Visits 5 and 6 only. Record the identifying number from the investigational product container dispensed at this visit-

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Randomisation
Descripción

Randomisation

Alias
UMLS CUI-1
C0034656
Was the subject able to be randomised?
Descripción

If yes, provided randomisation number and date

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
If Yes, provide randomisation number
Descripción

Randomisation number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Descripción

Date of randomisation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
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Similar models

Investigational Product, Container Numbers, Randomisation

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Visit
Code List
Study Visit
CL Item
Visit 4 (Visit 4)
CL Item
Visit 5 (Visit 5)
CL Item
Visit 6 (Visit 6)
CL Item
Visit 7 (Visit 7)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date/time of investigational product dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Investigational Product Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational product container number 1
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Investigational Product Container Number 2
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational product container number 2
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Randomisation possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomisation number
Item
If Yes, provide randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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