ID

16998

Beskrivning

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.

Länk

http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx

Nyckelord

  1. 2016-08-19 2016-08-19 -
Uppladdad den

19 augusti 2016

DOI

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Licens

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

General Information
Beskrivning

General Information

Protocol Title
Beskrivning

Protocol Title

Datatyp

text

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Site Number
Beskrivning

Site Number

Datatyp

integer

Pt_ID
Beskrivning

Pt_ID

Datatyp

integer

SAE Report Form
Beskrivning

SAE Report Form

1. SAE Start Date
Beskrivning

1. SAE Start Date

Datatyp

date

2. SAE Stop Date
Beskrivning

2. SAE Stop Date

Datatyp

date

3. Location of serious adverse event
Beskrivning

3. Location of serious adverse event

Datatyp

text

4. Was this an unexpected adverse event?
Beskrivning

4. Was this an unexpected adverse event?

Datatyp

boolean

5. Brief description of participant(s) with no personal identifiers: Sex
Beskrivning

5. Brief description of participant(s) with no personal identifiers

Datatyp

text

5. Brief description of participant(s) with no personal identifiers: Age
Beskrivning

5. Brief description of participant(s) with no personal identifiers

Datatyp

integer

6. Brief description of the nature of the serious adverse event
Beskrivning

6. Brief description of the nature of the serious adverse event

Datatyp

text

7. Category of the serious adverse event
Beskrivning

7. Category of the serious adverse event

Datatyp

text

If Other, please specify
Beskrivning

If Other, please specify

Datatyp

text

8. Intervention type: Medication or Nutritional Supplement
Beskrivning

8. Intervention type

Datatyp

boolean

Please specify
Beskrivning

Specification

Datatyp

text

Intervention type: Device
Beskrivning

Intervention type

Datatyp

boolean

Please specify
Beskrivning

Specification

Datatyp

text

Intervention type: Surgery
Beskrivning

Intervention type

Datatyp

boolean

Please specify
Beskrivning

Specification

Datatyp

text

Intervention type: Behavioral/ Life Style
Beskrivning

Intervention type

Datatyp

boolean

Please specify
Beskrivning

Specification

Datatyp

text

9. Relationship of intervention
Beskrivning

9. Relationship of intervention

Datatyp

text

10. Was study intervention discontinued due to event?
Beskrivning

10. Was study intervention discontinued due to event?

Datatyp

boolean

11. What medications or other steps were taken to treat serious adverse event?
Beskrivning

11. What medications or other steps were taken to treat serious adverse event?

Datatyp

text

12. List any relevant tests, laboratory data, history, including preexisting medical conditions
Beskrivning

12. List any relevant tests, laboratory data, history, including preexisting medical conditions

Datatyp

text

13. Type of report
Beskrivning

13. Type of report

Datatyp

text

Signature of Principal Investigator
Beskrivning

Signature of Principal Investigator

Datatyp

text

Date
Beskrivning

Date

Datatyp

date

Similar models

Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General Information
Protocol Title
Item
Protocol Title
text
Protocol Number
Item
Protocol Number
integer
Site Number
Item
Site Number
integer
Pt_ID
Item
Pt_ID
integer
Item Group
SAE Report Form
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
Item
7. Category of the serious adverse event
text
Code List
7. Category of the serious adverse event
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
Item
9. Relationship of intervention
text
Code List
9. Relationship of intervention
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
Item
13. Type of report
text
Code List
13. Type of report
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

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