Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100578

Follow-up Studies
Beschrijving

Follow-up Studies

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0016441
UMLS CUI-4
C0170300
Would the subject be willing to participate in a follow-up study?
Beschrijving

follow-up study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
reason for non participation
Beschrijving

If No, please specify the reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
Beschrijving

reason for non participation

Datatype

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0392360
Reason for non participation: Other, please specify
Beschrijving

reason for non participation

Datatype

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Investigator Signature
Beschrijving

I certify that I have reviewed the data in this case report form, and the Serious Adverse Event section (if applicable) and that all information is complete and accurate.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Long Term Follow-up
Beschrijving

Long Term Follow-up

Alias
UMLS CUI-1
C1517942
UMLS CUI-2
C0170300
Subject number of previous study
Beschrijving

Subject number of previous study

Datatype

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
Subject initials
Beschrijving

Subject initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0681850
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Beschrijving

long-term follow-up study participation

Datatype

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
Subject eligible but not willing to participate due to:
Beschrijving

long-term follow-up study participation

Datatype

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
If adverse events, or serious adverse event, please specify
Beschrijving

Subject eligible but not willing to participate due to

Datatype

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1517942
UMLS CUI [2,3]
C0170300
If Other, please specify
Beschrijving

Subject eligible but not willing to participate due to

Datatype

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
Investigator signature
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beschrijving

Investigator signature date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008

Similar models

Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100578

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Follow-up Studies
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0016441 (UMLS CUI-3)
C0170300 (UMLS CUI-4)
follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
reason for non participation
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
reason for non participation
Item
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
text
C0877248 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
reason for non participation
Item
Reason for non participation: Other, please specify
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Item Group
Long Term Follow-up
C1517942 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
Subject number of previous study
Item
Subject number of previous study
text
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
integer
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
Code List
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached  (2)
CL Item
Subject eligible but not willing to participate due to: (3)
CL Item
Subject eligible and agreed to participate in the long-term follow-up study (4)
Item
Subject eligible but not willing to participate due to:
integer
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
Code List
Subject eligible but not willing to participate due to:
CL Item
adverse events, or serious adverse event (1)
CL Item
Other (2)
long-term follow-up study participation
Item
If adverse events, or serious adverse event, please specify
text
C0877248 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1517942 (UMLS CUI [2,2])
C0170300 (UMLS CUI [2,3])
long-term follow-up study participation
Item
If Other, please specify
text
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])