ID

28997

Beschreibung

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.

Stichworte

Versionen (1)
  1. 20.02.18 20.02.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

20. Februar 2018

DOI

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Lizenz

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

Englisch

Informed consent

2 Formulare  
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI-1
C0021430
Subject No.
Beschreibung

Subject No.

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date
Beschreibung

Date

Datentyp

date

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

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.

Datentyp

text

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

Patient's name

Datentyp

text

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

Parent/Guardian’s name

Datentyp

text

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

Parent/Guardian’s signature

Datentyp

text

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

Relationship to participant

Datentyp

text

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

Participant’s main address

Datentyp

text

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

Participant’s phone number

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Time
Beschreibung

Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Witness
Beschreibung

Witness

Datentyp

text

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

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.

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Signature
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Designation
Beschreibung

Designation

Datentyp

text

Alias
UMLS CUI [1]
C0442504
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Time
Beschreibung

Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
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Ähnliche Modelle

Informed consent

2 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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