Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100579

Follow-up Studies
Descripción

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?
Descripción

follow-up study

Tipo de datos

boolean

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

If No, please specify the reason

Tipo de datos

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
Descripción

reason for non participation

Tipo de datos

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
Descripción

reason for non participation

Tipo de datos

text

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

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.

Tipo de datos

text

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

Long Term Follow-up

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

Subject number of previous study

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
Date of birth
Descripción

Date of birth

Tipo de datos

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.
Descripción

long-term follow-up study participation

Tipo de datos

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:
Descripción

long-term follow-up study participation

Tipo de datos

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
Descripción

Subject eligible but not willing to participate due to

Tipo de datos

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
Descripción

Subject eligible but not willing to participate due to

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
Date of contact
Descripción

Date of contact

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Investigator signature
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Descripción

Investigator signature date

Tipo de datos

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 100579

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
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])