Engelsk

Screening Conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Screening Conclusion
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Screening conclusion
Beskrivning

Screening conclusion

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710477
If subject experienced any SAE during sceening period, please specify total number of SAEs.
Beskrivning

SAE Number during screening

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1710477
Is the subject a screening failure?
Beskrivning

Was the subject withdrawn prior to randomisation or first vaccination?

Datatyp

boolean

Alias
UMLS CUI [1]
C1710476
If the subject was a screening failure, please tick the major reason for failure
Beskrivning

Tick one box only please specify protocol violation, SAE number, or other reason, if applicable

Datatyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
protocol violation specification
Beskrivning

if ticked as major reason for failure.

Datatyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
SAE number
Beskrivning

if "Serious adverse event" ticked as major reason for failure.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C1519255
other reason for screening failure specification
Beskrivning

if ticked "other" as major reason for failure.

Datatyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Who made the decision?
Beskrivning

Decision taken for screening failure

Datatyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0679006
Investigator's Signature
Beskrivning

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Beskrivning

Investigator's Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date of investigator's signature
Beskrivning

confirming "that I have reviewed the data in these screening forms 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."

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Beskrivning

(printed)

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Screening Conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Screening Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Screening conclusion
C1710477 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
SAE during screening
Item
Did the subject experience any Serious Adverse Event during screening?
boolean
C1519255 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
SAE Number during screening
Item
If subject experienced any SAE during sceening period, please specify total number of SAEs.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Screening failure
Item
Is the subject a screening failure?
boolean
C1710476 (UMLS CUI [1])
Item
If the subject was a screening failure, please tick the major reason for failure
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Screening failure
Code List
If the subject was a screening failure, please tick the major reason for failure
CL Item
Protocol violation, please specify (PTV)
CL Item
Serious adverse event, please complete and submit SAE report and specify SAE No. (SAE)
CL Item
Consent withdrawal 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, please specify (OTH)
CL Item
HIV+/+ not considered for study inclusion due to study enrolment criteria (HIV)
protocol violation specification
Item
protocol violation specification
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
SAE number
Item
SAE number
integer
C0600091 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
other reason for screening failure specification
Item
other reason for screening failure specification
text
C1710476 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Who made the decision?
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Decision taken
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Date of investigator's signature
Item
Date of investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
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