ID

16971

Description

ODM derived from: http://research.uic.edu/qip/toolbox/case-report-forms-crf. Template Name: Serious Adverse Event (SAE) Report Form. 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.

Link

http://research.uic.edu/qip/toolbox/case-report-forms-crf

Keywords

Versions (1)
  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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Serious Adverse Event (SAE) Report Form: UIC Quality Improvement CRF

English

Serious Adverse Event (SAE) Report Form: UIC Quality Improvement CRF

1 forms  
General Information
Description

General Information

Protocol Title
Description

Protocol Title

Data type

text

Site Number
Description

Site Number

Data type

integer

Subject ID
Description

Subject ID

Data type

integer

Visit Date
Description

Visit Date

Data type

date

Initial
Description

Initial

Data type

boolean

Follow-Up
Description

Follow-Up

Data type

boolean

If Follow-Up: Number
Description

If Follow-Up: Number

Data type

integer

Final
Description

Final

Data type

boolean

SAE
Description

SAE

1. SAE Start Date
Description

1. SAE Start Date

Data type

date

2. SAE Stop-Date
Description

2. SAE Stop-Date

Data type

date

3. Brief description of subject with no personal identifiers: Sex
Description

3. Brief description of subject with no personal identifiers

Data type

text

Brief description of subject with no personal identifiers: Age
Description

Brief description of subject with no personal identifiers

Data type

integer

4. Diagnosis for study participation
Description

4. Diagnosis for study participation

Data type

text

5. Brief description of the nature of the serious adverse event
Description

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

Data type

text

6. Study intervention: Medication or Nutritional Supplement
Description

6. Study intervention

Data type

boolean

If Medication or Nutritional Supplement, please specify
Description

Specification

Data type

text

Study intervention: Device
Description

Study intervention

Data type

boolean

If Device, please specify
Description

Specification

Data type

text

Study intervention: Surgery
Description

Study intervention

Data type

boolean

If Surgery, please specify
Description

Specification

Data type

text

Study intervention: Behavioral/Life Style
Description

Study intervention

Data type

boolean

If Behavioral/Life Style, please specify
Description

Specification

Data type

text

7. Was study intervention interrupted due to the adverse event?
Description

7. Was study intervention interrupted due to the adverse event?

Data type

boolean

8. Was study intervention discontinued due to the adverse event?
Description

8. Was study intervention discontinued due to the adverse event?

Data type

boolean

9. What medications or other steps were taken to treat the serious adverse event?
Description

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

Data type

text

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

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

Data type

text

11. Was this an unexpected adverse event?
Description

11. Was this an unexpected adverse event?

Data type

boolean

12. Category of the serious adverse event
Description

12. Category of the serious adverse event

Data type

text

If Death, please specify date
Description

Specification

Data type

date

If Other, please specify
Description

Specification

Data type

text

13. Relationship of event to study intervention
Description

13. Relationship of event to study intervention

Data type

text

14. Outcome of serious adverse event
Description

14. Outcome of serious adverse event

Data type

text

15. Subject Participation
Description

15. Subject Participation

Data type

text

16. Date reported to Sponsor
Description

16. Date reported to Sponsor

Data type

date

16. Date reported to IRB
Description

16. Date reported to IRB

Data type

date

Signature (See Description)
Description

Must be the PI or individual delegated by the PI to perform this task

Data type

text

Date
Description

Date

Data type

date

Printed Name
Description

Printed Name

Data type

text

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Similar models

Serious Adverse Event (SAE) Report Form: UIC Quality Improvement CRF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
Visit Date
Item
Visit Date
date
Initial
Item
Initial
boolean
Follow-Up
Item
Follow-Up
boolean
If Follow-Up: Number
Item
If Follow-Up: Number
integer
Final
Item
Final
boolean
Item Group
SAE
1. SAE Start Date
Item
1. SAE Start Date
date
2. SAE Stop-Date
Item
2. SAE Stop-Date
date
Item
3. Brief description of subject with no personal identifiers: Sex
text
3. Brief description of subject with no personal identifiers
Code List
3. Brief description of subject with no personal identifiers: Sex
CL Item
F (1)
CL Item
M (2)
Brief description of subject with no personal identifiers
Item
Brief description of subject with no personal identifiers: Age
integer
4. Diagnosis for study participation
Item
4. Diagnosis for study participation
text
5. Brief description of the nature of the serious adverse event
Item
5. Brief description of the nature of the serious adverse event
text
6. Study intervention
Item
6. Study intervention: Medication or Nutritional Supplement
boolean
Specification
Item
If Medication or Nutritional Supplement, please specify
text
Study intervention
Item
Study intervention: Device
boolean
Specification
Item
If Device, please specify
text
Study intervention
Item
Study intervention: Surgery
boolean
Specification
Item
If Surgery, please specify
text
Study intervention
Item
Study intervention: Behavioral/Life Style
boolean
Specification
Item
If Behavioral/Life Style, please specify
text
7. Was study intervention interrupted due to the adverse event?
Item
7. Was study intervention interrupted due to the adverse event?
boolean
8. Was study intervention discontinued due to the adverse event?
Item
8. Was study intervention discontinued due to the adverse event?
boolean
9. What medications or other steps were taken to treat the serious adverse event?
Item
9. What medications or other steps were taken to treat the serious adverse event?
text
10. List any relevant tests, laboratory data, history, including preexisting medical conditions.
Item
10. List any relevant tests, laboratory data, history, including preexisting medical conditions.
text
11. Was this an unexpected adverse event?
Item
11. Was this an unexpected adverse event?
boolean
Item
12. Category of the serious adverse event
text
12. Category of the serious adverse event
Code List
12. 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)
Specification
Item
If Death, please specify date
date
Specification
Item
If Other, please specify
text
Item
13. Relationship of event to study intervention
text
13. Relationship of event to study intervention
Code List
13. Relationship of event to study intervention
CL Item
Definitely related (clearly related to intervention) (1)
CL Item
Possibly related (may be related to intervention) (2)
CL Item
Not related (clearly not related to the intervention) (3)
Item
14. Outcome of serious adverse event
text
14. Outcome of serious adverse event
Code List
14. Outcome of serious adverse event
CL Item
Resolved, No Sequelae (1)
CL Item
SAE still present - no treatment (2)
CL Item
SAE still present - being treated  (3)
CL Item
Residual effects present - not treated  (4)
CL Item
Residual effects present - treated (5)
CL Item
Death (6)
CL Item
Unknown (7)
Item
15. Subject Participation
text
15. Subject Participation
Code List
15. Subject Participation
CL Item
Continued in study (1)
CL Item
Continued in study after temporarily stopping study interventions (2)
CL Item
Continued in follow-up only (3)
CL Item
Subject withdrew from participation or died (4)
CL Item
Withdrawn from study by PI (5)
CL Item
Participation completed (6)
16. Date reported to Sponsor
Item
16. Date reported to Sponsor
date
16. Date reported to IRB
Item
16. Date reported to IRB
date
Signature (See Description)
Item
Signature (See Description)
text
Date
Item
Date
date
Printed Name
Item
Printed Name
text
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