ID

18749

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Serious Adverse Event Part I. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Link

https://ictr.wisc.edu/CaseReptTempt

Keywords

Versions (2)
  1. 7/27/16 7/27/16 -
  2. 11/18/16 11/18/16 -
Uploaded on

November 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Serious Adverse Event Part I: CRF Wisconsin Madison

English

Serious Adverse Event Part I: CRF Wisconsin Madison

1 forms  
Header
Description

Header

PI Name
Description

PI Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1521895
Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Alias
UMLS CUI [1]
C2348563
Protocol Short Title
Description

Protocol Short Title

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1705824
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Serious Adverse Event
Description

Serious Adverse Event

Event Start Date
Description

Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
Event End Date
Description

Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
Date Reported
Description

Date Reported

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0700287
Reported to Research Staff Bv
Description

Reported to Research Staff Bv

Data type

text

Alias
UMLS CUI [1,1]
C0700287
UMLS CUI [1,2]
C2986262
Death Date (if applicable)
Description

Death Date (if applicable)

Data type

date

Alias
UMLS CUI [1]
C1148348
Death Occurred
Description

Death Occurred

Data type

text

Alias
UMLS CUI [1,1]
C1306577
UMLS CUI [1,2]
C2745955
Did the SAE occur at your site or at a site for which the PI is responsible?
Description

SAE

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678341
SAE Description/Narrative
Description

SAE Description/Narrative

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Treating Physician Comments (if applicable)
Description

Treating Physician Comments (if applicable)

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1710470
PI Comments
Description

PI Comments

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1521895
Outcome
Description

Outcome

Data type

text

Consent Form Change Required?
Description

Consent Form Change Required?

Data type

boolean

Alias
UMLS CUI [1,1]
C0009797
UMLS CUI [1,2]
C0392747
SAE Classification: Fatal (resulted in death)
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C1302234
SAE Classification: A life-threatening occurrence
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C2826244
SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C0019993
SAE Classification: Results in persistent or significant disability/incapacity
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C0231170
SAE Classification: Results in congenital anomaly/birth defect
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C0000768
SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C4035998
SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
Description

SAE Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1706737
UMLS CUI [1,2]
C3845751
UMLS CUI [2]
C0683675
UMLS CUI [3]
C0870486
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Similar models

Serious Adverse Event Part I: CRF Wisconsin Madison

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Serious Adverse Event
Event Start Date
Item
Event Start Date
date
C2697888 (UMLS CUI [1])
Event End Date
Item
Event End Date
date
C2697886 (UMLS CUI [1])
Date Reported
Item
Date Reported
date
C0011008 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Reported to Research Staff Bv
Item
Reported to Research Staff Bv
text
C0700287 (UMLS CUI [1,1])
C2986262 (UMLS CUI [1,2])
Death Date (if applicable)
Item
Death Date (if applicable)
date
C1148348 (UMLS CUI [1])
Item
Death Occurred
text
C1306577 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Death Occurred
Code List
Death Occurred
CL Item
Within 24 hours of investigational therapy  (1)
CL Item
Within 7 days of investigational therapy  (2)
CL Item
Within 30 days of investigational therapy  (3)
CL Item
After 30 days of investigational therapy (4)
SAE
Item
Did the SAE occur at your site or at a site for which the PI is responsible?
boolean
C1519255 (UMLS CUI [1,1])
C0678341 (UMLS CUI [1,2])
SAE Description/Narrative
Item
SAE Description/Narrative
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Treating Physician Comments (if applicable)
Item
Treating Physician Comments (if applicable)
text
C0947611 (UMLS CUI [1,1])
C1710470 (UMLS CUI [1,2])
PI Comments
Item
PI Comments
text
C0947611 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Fatal/ Died  (1)
CL Item
Intervention for AE Continuing  (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae  (4)
CL Item
Recovered/Resolved without Sequelae (5)
CL Item
Recovering/Resolving (6)
Consent Form Change Required?
Item
Consent Form Change Required?
boolean
C0009797 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Fatal (resulted in death)
boolean
C1706737 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: A life-threatening occurrence
boolean
C1706737 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
boolean
C1706737 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Results in persistent or significant disability/incapacity
boolean
C1706737 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Results in congenital anomaly/birth defect
boolean
C1706737 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
boolean
C1706737 (UMLS CUI [1,1])
C4035998 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
boolean
C1706737 (UMLS CUI [1,1])
C3845751 (UMLS CUI [1,2])
C0683675 (UMLS CUI [2])
C0870486 (UMLS CUI [3])
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