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Screening Conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Screening Conclusion
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Screening Conclusion
Beschrijving

Screening Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C1710477
Did the subject experience any Serious Adverse Event during screening?
Beschrijving

(only SAEs related to study participation or to a concurrent medication need to be considered and reported)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1710477
If yes, specify total number of SAEs.
Beschrijving

Serious adverse event during trial screening count specification

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1710477
UMLS CUI [1,4]
C0750480
UMLS CUI [1,5]
C1521902
Is the subject a screening failure?
Beschrijving

(Was the subject withdrawn prior to randomisation or first vaccination?)

Datatype

boolean

Alias
UMLS CUI [1]
C1710476
UMLS CUI [2,1]
C2349954
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0034656
UMLS CUI [3,1]
C2349954
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0042196
If yes, indicate the major reason for failure.
Beschrijving

Please tick one box only. If eligibility criteria not fulfilled, please tick failing criteria on Eligibility form. If serious adverse event, please complete and submit SAE report.

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
If protocol violation [PTV], please specify.
Beschrijving

Trial screen failure protocol violation specification

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C1709750
UMLS CUI [1,3]
C1521902
If serious adverse event [SAE], please specify SAE number.
Beschrijving

Trial screen failure serious adverse event number

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If other [OTH], please specify.
Beschrijving

Trial screen failure reason and justification specification

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C1521902
If yes, indicate who made the decision.
Beschrijving

Trial screen failure decision

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0679006
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschrijving

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Printed investigator's name
Beschrijving

Investigator name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date
Beschrijving

Investigator signature date

Datatype

date

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

Screening Conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Screening Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Screening Conclusion
C1707478 (UMLS CUI-1)
C1710477 (UMLS CUI-2)
Serious adverse event during trial screening
Item
Did the subject experience any Serious Adverse Event during screening?
boolean
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Serious adverse event during trial screening count specification
Item
If yes, specify total number of SAEs.
integer
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Trial screen failure | withdrawal before randomization | withdrawal before vaccination
Item
Is the subject a screening failure?
boolean
C1710476 (UMLS CUI [1])
C2349954 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0034656 (UMLS CUI [2,3])
C2349954 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0042196 (UMLS CUI [3,3])
Item
If yes, indicate the major reason for failure.
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Trial Screen Failure | withdrawal before randomization | withdrawal before vaccination
Code List
If yes, indicate the major reason for failure.
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria) ([ELI])
CL Item
Protocol violation ([PTV])
CL Item
Serious adverse event ([SAE])
CL Item
Consent withdrawal / not willing to participate, not due to a serious adverse event ([CWS])
CL Item
Migrated / moved from the study area ([MIG])
CL Item
Lost to follow-up ([LFU])
CL Item
Other ([OTH])
Trial screen failure protocol violation specification
Item
If protocol violation [PTV], please specify.
text
C1710476 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Trial screen failure serious adverse event number
Item
If serious adverse event [SAE], please specify SAE number.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Trial screen failure reason and justification specification
Item
If other [OTH], please specify.
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item
If yes, indicate who made the decision.
text
C1710476 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Trial Screen Failure | withdrawal before randomization | withdrawal before vaccination
Code List
If yes, indicate who made the decision.
CL Item
Investigator ([I])
CL Item
Subject/Parents/Guardians ([S]/[P])
Item Group
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Printed investigator's name
text
C2826892 (UMLS CUI [1])
Investigator signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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