Informatie:
Fout:
ID
29002
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)
- 20-02-18 20-02-18 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
20 februari 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518
Visit 2 Check for study continuation and laboratory tests
- StudyEvent: ODM
Similar models
Visit 2 Check for study continuation and laboratory tests
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
study continuation
Item
Did the subject come at visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0205160 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0205160 (UMLS CUI [1,4])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N°: |__|__| ([SAE])
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N° : |__|__| or solicited AE code : |__|__| ([AEX])
CL Item
Other, please specify : ___________________________________________________ (e.g.: consent withdrawal, Protocol violation, ...) ([OTH])
Item
Please tick who took the decision :
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator ([I])
CL Item
Parents/Guardian ([P])
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample
Item
Date of blood sample, please complete only if different from visit date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])