Tracking Document

  1. StudyEvent: ODM
    1. Tracking Document
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Previous Subject Number
Description

Previous Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Center
Description

Center

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Contact
Description

Date of Contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Reason for Non Participation
Description

Reason for Non Participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Please document reason for non participation
Description

Reason for Non Participation

Data type

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
please specify criteria that are not fullfilled
Description

If main reason for non-participation was that the subject was not eligible

Data type

text

Alias
UMLS CUI [1,1]
C3242266
UMLS CUI [1,2]
C2348235
Adverse Event or Serious Adverse Event Specification
Description

Adverse Event or Serious Adverse Event Specification

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C2348235
please specify
Description

Other Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Subject died on
Description

Date the Subject Died

Data type

date

Alias
UMLS CUI [1]
C1148348
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Has the subject had any serious adverse event since the phone contact, day 30 (FLU-LD-001)?
Description

If yes, check the following items and check SAE forms have been submitted to GSK Biologicals.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Specify number of SAEs
Description

Number of SAEs

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255

Similar models

Tracking Document

  1. StudyEvent: ODM
    1. Tracking Document
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Previous Subject Number
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Center
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Contact
Item
Date of Contact
date
C0805839 (UMLS CUI [1])
Item Group
Reason for Non Participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Item
Please document reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
Please document reason for non participation
CL Item
Subject not Eligible (1)
CL Item
Subject los to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse event (3)
CL Item
Subject eligible but not willing to participate due to other reason (4)
CL Item
Subject died (5)
Specification Criteria Not Fulfilled
Item
please specify criteria that are not fullfilled
text
C3242266 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Adverse Event or Serious Adverse Event Specification
Item
Adverse Event or Serious Adverse Event Specification
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other Specification
Item
please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date the Subject Died
Item
Subject died on
date
C1148348 (UMLS CUI [1])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Has the subject had any serious adverse event since the phone contact, day 30 (FLU-LD-001)?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Specify number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])