Information:
Error:
ID
16975
Description
ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Adverse Events. University of Alberta, Quality Management in Clinical Research. Copyright: 2002-2016 University of Alberta.
Link
http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx
Keywords
Versions (1)
- 8/17/16 8/17/16 -
Uploaded on
August 17, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Adverse Events: CRF QMCR University of Alberta
Adverse Events: CRF QMCR University of Alberta
- StudyEvent: ODM
Similar models
Adverse Events: CRF QMCR University of Alberta
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Study Name
Item
Study Name
text
Site Number
Item
Site Number
integer
Pt_ID
Item
Pt_ID
integer
Has the participant had any Adverse Events during this Study? (see Description)
Item
Has the participant had any Adverse Events during this Study? (see Description)
boolean
Adverse Event
Item
Adverse Event
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Definitely related (1)
CL Item
Possibly related (2)
CL Item
Not related (3)
Action Taken (see Description)
Item
Action Taken (see Description)
integer
Outcome of AE (see Description)
Item
Outcome of AE (see Description)
integer
Expected?
Item
Expected?
boolean
CL Item
Yes (complete SAE form) (1)
CL Item
No (2)
Initials
Item
Initials
text