Information:
Fel:
ID
16968
Beskrivning
ODM derived from: http://research.uic.edu/qip/toolbox/case-report-forms-crf. Template Name: Adverse Events. QIP Case Report Forms, UIC Quality Improvement CRF, Office of the Vice Chancellor for Research. Center for Clinical and Translational Science, UIC University of Illinois at Chicago.
Länk
http://research.uic.edu/qip/toolbox/case-report-forms-crf
Nyckelord
Versioner (1)
- 2016-08-17 2016-08-17 -
Uppladdad den
17 augusti 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Adverse Events: UIC Quality Improvement CRF
Adverse Events: UIC Quality Improvement CRF
- StudyEvent: ODM
Similar models
Adverse Events: UIC Quality Improvement CRF
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
Visit Date
Item
Visit Date
date
Has the subject had any Adverse Events during this study? (See description)
Item
Has the subject had any Adverse Events during this study? (See description)
boolean
Event Description
Item
Event Description
text
Start Date
Item
Start Date
date
Severity (see Description)
Item
Severity (see Description)
integer
Action Taken
Item
Action Taken: None
boolean
Action Taken
Item
boolean
Action Taken
Item
Action Taken: Interrupted temporarily
boolean
Action Taken
Item
Action Taken: Reduced Dose
boolean
Action Taken
Item
Action Taken: Increased Dose
boolean
Action Taken
Item
Action Taken: Delayed Dose
boolean
Final Outcome (see Description)
Item
Final Outcome (see Description)
integer
Stop Date
Item
Stop Date
date
OR: Continuing
Item
OR: Continuing
boolean
Item
Event Analysis: Relationship to Study Intervention (see Description)
text
Code List
Event Analysis: Relationship to Study Intervention (see Description)
CL Item
Definitely related (1)
CL Item
Possibly related (2)
CL Item
Not related (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Yes (Complete an SAE report form) (1)
CL Item
No (2)
PI Initials
Item
PI Initials
text