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Run-In Failure Report

1 forms  
  1. StudyEvent: ODM
    1. Run-In Failure Report
Run-In Failure
Description

Run-In Failure

Was this subject a run-in failure?
Description

Was this subject a run-in failure?

Data type

boolean

If YES, complete run-in reason
Description

If YES, complete run-in reason

Data type

text

If INVESTIGATOR DISCRETION, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

If WITHDREW CONSENT, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

Run-In Failure Date
Description

Run-In Failure Date

Data type

date

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Similar models

Run-In Failure Report

1 forms
  1. StudyEvent: ODM
    1. Run-In Failure Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Run-In Failure
Was this subject a run-in failure?
Item
Was this subject a run-in failure?
boolean
Item
If YES, complete run-in reason
text
If YES, complete run-in reason
Code List
If YES, complete run-in reason
CL Item
Adverse event (record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate) (1)
CL Item
Protocol Deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion (5)
CL Item
Withdrew consent (6)
CL Item
Did not meet continuation criteria (7)
If INVESTIGATOR DISCRETION, specify
Item
If INVESTIGATOR DISCRETION, specify
text
If WITHDREW CONSENT, specify
Item
If WITHDREW CONSENT, specify
text
Run-In Failure Date
Item
Run-In Failure Date
date
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