Engelsk

Concomitant Vaccination

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Beskrivning

Cohort

Datatyp

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Concomitant Vaccination
Beskrivning

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Have any vaccines other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Beskrivning

Any vaccine not foreseen in the study protocol administered during the period beginning 30 days preceding the first dose of the study vaccines and during the entire study period is to be recorded in this “concomitant medication/vaccination” form with trade name and/or generic name, route of administration and date(s) of administration. If yes, fill in the itemgroup below or each vaccine.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C1948053
UMLS CUI [1,5]
C2348563
Concomitant Vaccination Details
Beskrivning

Concomitant Vaccination Details

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
UMLS CUI-3
C2348235
Vaccination Trade Name/ (Generic) Name
Beskrivning

Vaccination Trade Name/ (Generic) Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2360065
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0592502
Vaccination Administration Route
Beskrivning

Vaccination Administration Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042196
Vaccination Administration Date
Beskrivning

Vaccination Administration Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042196
Sponsor Comment
Beskrivning

(for GSK)

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2347796
Tillbaka till toppen

Similar models

Concomitant Vaccination

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Interim Analysis at/after Visit 6 (1)
CL Item
End of Study Analysis at/after Visit 10 (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant vaccines during protocol-specified period?
Item
Have any vaccines other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,5])
Item Group
Concomitant Vaccination Details
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2348235 (UMLS CUI-3)
Vaccination Trade Name/ (Generic) Name
Item
Vaccination Trade Name/ (Generic) Name
text
C0042196 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
Item
Vaccination Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Administration Route
Code List
Vaccination Administration Route
CL Item
Intradermal  (ID)
CL Item
Inhalation  (IH)
CL Item
Intramuscular  (IM)
CL Item
Intravenous  (IV)
CL Item
Other  (OTH)
CL Item
Parenteral  (PE)
CL Item
Oral  (PO)
CL Item
Subcutaneous  (SC)
CL Item
Sublingual  (SL)
CL Item
Transdermal  (TD)
CL Item
Unknown  (UNK)
CL Item
Intranasal  (IN)
Vaccination Administration Date
Item
Vaccination Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Sponsor Comment
Item
Sponsor Comment
text
C0947611 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Tillbaka till toppen