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Investigational Product - IV Dosing, Randomisation, Cohort Assignment

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject ID
Beskrivning

Subject ID

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

please fill in the form for each of the three study days

Datatyp

integer

Alias
UMLS CUI [1]
C1320303
Which Cohort is the subject enrolled in?
Beskrivning

Please ensure the Cohort selected is correct before submitting. Medication is infused over 4 or 24 hours depending on the cohort.

Datatyp

text

Alias
UMLS CUI [1]
C0599755
Date/Time of Cohort Assignment
Beskrivning

Date/Time of Cohort Assignment

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C1516050
UMLS CUI [1,3]
C1264639
First Administration
Beskrivning

First Administration

Alias
UMLS CUI-1
C3469597
Dosage Duration (per Protocol)
Beskrivning

Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24hrs

Datatyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Start Date and Time
Beskrivning

Start Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C3897500
Stop Date and Time
Beskrivning

Stop Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C3899266
Volume administered (mL)
Beskrivning

Volume administered

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1]
C2349139
mL
Administration post interruption
Beskrivning

Administration post interruption

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0687676
UMLS CUI-3
C1512900
Dosage Duration (per Protocol)
Beskrivning

Cohorts 1/3: 0-4 hrs Cohorts 2/4: 0-24 hrs

Datatyp

integer

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Start Date and Time
Beskrivning

Start Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C3897500
Stop Date and Time
Beskrivning

Stop Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C3899266
Volume administered (mL)
Beskrivning

Volume administered

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1]
C2349139
mL
Investigational Product Container Number
Beskrivning

Investigational Product Container Number

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0180098
UMLS CUI-3
C0600091
Investigational Product Container Number
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Treatment Confirmation
Beskrivning

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

If no, record reasons

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
Reason incorrect treatment
Beskrivning

if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3827420
Randomisation Number
Beskrivning

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Beskrivning

If yes, provide Randomisation Number and Date/time of randomisation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
Randomisation Number
Beskrivning

if applicable

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date/time of randomisation
Beskrivning

if applicable

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1264639
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Similar models

Investigational Product - IV Dosing, Randomisation, Cohort Assignment

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item
Date of Visit
integer
C1320303 (UMLS CUI [1])
Date of Visit
Code List
Date of Visit
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
Item
Which Cohort is the subject enrolled in?
text
C0599755 (UMLS CUI [1])
Cohort
Code List
Which Cohort is the subject enrolled in?
CL Item
Cohort 1 (3mg/Placebo IV / 4hrs) (C1)
CL Item
Cohort 2 (7.5mg/Placebo IV / 24hrs) (C2)
CL Item
Cohort 3 (7.5mg/Placebo IV / 4hrs) (C3)
CL Item
Cohort 4 (10mg/Placebo IV / 24hrs) (C4)
Date/Time of Cohort Assignment
Item
Date/Time of Cohort Assignment
datetime
C0599755 (UMLS CUI [1,1])
C1516050 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
First Administration
C3469597 (UMLS CUI-1)
Item
Dosage Duration (per Protocol)
integer
C0449238 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Dosage Duration
Code List
Dosage Duration (per Protocol)
CL Item
0-4 hrs (1)
CL Item
0-24 hrs (2)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
Volume administered
Item
Volume administered (mL)
float
C2349139 (UMLS CUI [1])
Item Group
Administration post interruption
C3469597 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C1512900 (UMLS CUI-3)
Item
Dosage Duration (per Protocol)
integer
C0449238 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Dosage Duration
Code List
Dosage Duration (per Protocol)
CL Item
0-4 hrs (1)
CL Item
0-24 hrs (2)
Start Date and Time
Item
Start Date and Time
datetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
datetime
C3899266 (UMLS CUI [1])
Volume administered
Item
Volume administered (mL)
float
C2349139 (UMLS CUI [1])
Item Group
Investigational Product Container Number
C0304229 (UMLS CUI-1)
C0180098 (UMLS CUI-2)
C0600091 (UMLS CUI-3)
Investigational Product Container Number
Item
Investigational Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Correct treatment received
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Reason incorrect treatment
Item
Reason incorrect treatment
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomisation Date/Time
Item
Date/time of randomisation
datetime
C0034656 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
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