ID

28997

Description

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518

English

Informed consent

2 forms  
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
Subject No.
Description

Subject No.

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Participant’s parent or legal guardian’s first name and family name
Description

The DTPa-HBV-IPV/Hib vaccine study has been clearly explained to me and I have read and understood the information provided. I agree that my [son/daughter/ward] be enrolled in the study. I understand that I have the right to decline to enter my [son/daughter/ward] into the study and to withdraw from it at any time for any reasons, without consequence to his/her present or future health care and attention which my child/ward receives from his/her healthcare provider. I have been made aware of my right to access and request correction of my child’s/ward’s personal data. I acknowledge that I have received a copy of this form for future reference.

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C0085537
Participant’s Name, (First Name, Family Name)
Description

Patient's name

Data type

text

Alias
UMLS CUI [1]
C1299487
Parent/Guardian’s name, (First Name, Family Name)
Description

Parent/Guardian’s name

Data type

text

Alias
UMLS CUI [1,1]
C0023226
UMLS CUI [1,2]
C0027365
Parent/Guardian’s signature
Description

Parent/Guardian’s signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C1274041
Relationship to participant
Description

Relationship to participant

Data type

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0679646
Participant’s main address
Description

Participant’s main address

Data type

text

Alias
UMLS CUI [1]
C0421449
Participant’s phone number
Description

Participant’s phone number

Data type

integer

Alias
UMLS CUI [1]
C1515258
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Witness
Description

Witness

Data type

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0021430
Name
Description

Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion: I have carefully explained the nature, demands and foreseeable risks and benefits of the vaccination study to the person named above and witnessed the completion of the written consent form.

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Designation
Description

Designation

Data type

text

Alias
UMLS CUI [1]
C0442504
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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Similar models

Informed consent

2 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0021430 (UMLS CUI-1)
Subject No.
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Name
Item
Participant’s parent or legal guardian’s first name and family name
text
C0027365 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0085537 (UMLS CUI [1,3])
Patient's name
Item
Participant’s Name, (First Name, Family Name)
text
C1299487 (UMLS CUI [1])
Parent/Guardian’s name
Item
Parent/Guardian’s name, (First Name, Family Name)
text
C0023226 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Parent/Guardian’s signature
Item
Parent/Guardian’s signature
text
C1519316 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C1274041 (UMLS CUI [1,3])
Relationship to participant
Item
Relationship to participant
text
C0439849 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
Participant’s main address
Item
Participant’s main address
text
C0421449 (UMLS CUI [1])
Participant’s phone number
Item
Participant’s phone number
integer
C1515258 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Witness
Item
Witness
text
C0682356 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Name
Item
Name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Designation
Item
Designation
text
C0442504 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
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