ID

28997

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 20-02-18 20-02-18 -
Houder van rechten

GlaxoSmithKline (GSK)

Geüploaded op

20 februari 2018

DOI

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Licentie

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

Engels

Informed consent

2 Formulieren  
Informed consent
Beschrijving

Informed consent

Alias
UMLS CUI-1
C0021430
Subject No.
Beschrijving

Subject No.

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date
Beschrijving

Date

Datatype

date

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

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.

Datatype

text

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

Patient's name

Datatype

text

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

Parent/Guardian’s name

Datatype

text

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

Parent/Guardian’s signature

Datatype

text

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

Relationship to participant

Datatype

text

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

Participant’s main address

Datatype

text

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

Participant’s phone number

Datatype

integer

Alias
UMLS CUI [1]
C1515258
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Witness
Beschrijving

Witness

Datatype

text

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

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.

Datatype

text

Alias
UMLS CUI [1]
C2826892
Signature
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Designation
Beschrijving

Designation

Datatype

text

Alias
UMLS CUI [1]
C0442504
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
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Similar models

Informed consent

2 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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