ID

33870

Beschreibung

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Stichworte

Versionen (1)
  1. 04.01.19 04.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Januar 2019

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

Englisch

Informed Consent

1 Formulare  
  1. StudyEvent: ODM
    1. Informed Consent
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0030705
Subject’s first name and family name
Beschreibung

The aims and procedures of this study have been clearly explained to me and I have read the preceding information sheet and understood the information provided. I agree to be enrolled in the study. I understand that I have the right to decline to enter the study and to withdraw from it at any time for any reasons, without consequence to my present or future health care and attention which I receive from my healthcare provider. I have been made aware of my right to access and request correction of my personal data. I acknowledge that I have received a copy of this form for future reference. I hereby freely give my consent to take part in this study.

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Participant’s signature
Beschreibung

Participant, Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1519316
Participant’s main address
Beschreibung

Patient address

Datentyp

text

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

Participant, Telephone Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1515258
Date
Beschreibung

Informed Consent, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Time
Beschreibung

Informed Consent, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0040223
Witness
Beschreibung

Informed Consent, Witnesses

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0682356
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion
Beschreibung

Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0035173
Name
Beschreibung

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 [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0027365
Signature
Beschreibung

Informed Consent, Research Personnel, Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C1519316
Designation
Beschreibung

Informed Consent, Research Personnel, Occupations

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0028811
Date
Beschreibung

Informed Consent, Research Personnel, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0011008
Time
Beschreibung

Informed Consent, Research Personnel, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C0040223
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Ähnliche Modelle

Informed Consent

1 Formulare
  1. StudyEvent: ODM
    1. Informed Consent
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
Patient Name
Item
Subject’s first name and family name
text
C1299487 (UMLS CUI [1])
Participant, Signature
Item
Participant’s signature
text
C0679646 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Patient address
Item
Participant’s main address
text
C0421449 (UMLS CUI [1])
Participant, Telephone Number
Item
Participant’s phone number
integer
C0679646 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Informed Consent, Date in time
Item
Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Informed Consent, Time
Item
Time
time
C0021430 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Informed Consent, Witnesses
Item
Witness
text
C0021430 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion
C0021430 (UMLS CUI-1)
C0035173 (UMLS CUI-2)
Informed Consent, Research Personnel, Name
Item
Name
text
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Signature
Item
Signature
text
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Occupations
Item
Designation
text
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Date in time
Item
Date
date
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Informed Consent, Research Personnel, Time
Item
Time
time
C0021430 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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