Informationen:
Fehler:
ID
16998
Beschreibung
ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Serious Adverse Event (SAE) Report Form. University of Alberta, Quality Management in Clinical Research. Copyright: 2002-2016 University of Alberta.
Link
http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx
Stichworte
Versionen (1)
- 19.08.16 19.08.16 -
Hochgeladen am
19. August 2016
DOI
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Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta
Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta
Ähnliche Modelle
Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Protocol Title
Item
Protocol Title
text
Protocol Number
Item
Protocol Number
integer
Site Number
Item
Site Number
integer
Pt_ID
Item
Pt_ID
integer
1. SAE Start Date
Item
1. SAE Start Date
date
2. SAE Stop Date
Item
2. SAE Stop Date
date
3. Location of serious adverse event
Item
3. Location of serious adverse event
text
4. Was this an unexpected adverse event?
Item
4. Was this an unexpected adverse event?
boolean
Item
5. Brief description of participant(s) with no personal identifiers: Sex
text
Code List
5. Brief description of participant(s) with no personal identifiers: Sex
CL Item
F (1)
CL Item
M (2)
5. Brief description of participant(s) with no personal identifiers
Item
5. Brief description of participant(s) with no personal identifiers: Age
integer
6. Brief description of the nature of the serious adverse event
Item
6. Brief description of the nature of the serious adverse event
text
CL Item
death - date:____ (1)
CL Item
life-threatening (2)
CL Item
hospitalization-initial or prolonged (3)
CL Item
disability/incapacity (4)
CL Item
congenital anomaly / birth defect (5)
CL Item
required intervention to prevent permanent impairment (6)
CL Item
Other (7)
If Other, please specify
Item
If Other, please specify
text
8. Intervention type
Item
8. Intervention type: Medication or Nutritional Supplement
boolean
Specification
Item
Please specify
text
Intervention type
Item
Intervention type: Device
boolean
Specification
Item
Please specify
text
Intervention type
Item
Intervention type: Surgery
boolean
Specification
Item
Please specify
text
Intervention type
Item
Intervention type: Behavioral/ Life Style
boolean
Specification
Item
Please specify
text
CL Item
unrelated (clearly not related to the intervention) (1)
CL Item
possible (may be related to intervention) (2)
CL Item
definite (clearly related to intervention) (3)
10. Was study intervention discontinued due to event?
Item
10. Was study intervention discontinued due to event?
boolean
11. What medications or other steps were taken to treat serious adverse event?
Item
11. What medications or other steps were taken to treat serious adverse event?
text
12. List any relevant tests, laboratory data, history, including preexisting medical conditions
Item
12. List any relevant tests, laboratory data, history, including preexisting medical conditions
text
CL Item
initial (1)
CL Item
follow-up (2)
CL Item
final (3)
Signature of Principal Investigator
Item
Signature of Principal Investigator
text
Date
Item
Date
date