Informações:
Falhas:
ID
29002
Descrição
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.
Palavras-chave
Versões (1)
- 20/02/2018 20/02/2018 -
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
20 de fevereiro de 2018
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])