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ID
16971
Beschrijving
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
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Versies (1)
- 17-08-16 17-08-16 -
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17 augustus 2016
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Creative Commons BY-NC 3.0
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Serious Adverse Event (SAE) Report Form: UIC Quality Improvement CRF
Serious Adverse Event (SAE) Report Form: UIC Quality Improvement CRF
Similar models
Serious Adverse Event (SAE) Report Form: UIC Quality Improvement CRF
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Initial
Item
Initial
boolean
Follow-Up
Item
Follow-Up
boolean
If Follow-Up: Number
Item
If Follow-Up: Number
integer
Final
Item
Final
boolean
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
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
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
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)
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)
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