ID

16632

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Serious Adverse Event Part II. 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. 11/20/16 11/20/16 -
Uploaded on

July 27, 2016

DOI

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License

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

English

Serious Adverse Event Part II: CRF Wisconsin Madison

1 forms  
Header
Description

Header

PI Name
Description

PI Name

Data type

text

Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Protocol Short Title
Description

Protocol Short Title

Data type

text

Subject Initials
Description

Subject Initials

Data type

text

Subject ID
Description

Subject ID

Data type

integer

Serious Adverse Event
Description

Serious Adverse Event

Report to the IRB
Description

Report to the IRB

Data type

text

Course start date (Enter date that course of treatment was initiated, if applicable)
Description

Course start date

Data type

date

AE Description/Details
Description

AE Description/Details

Data type

text

Category
Description

(refer to the Safety Profiler website to search the Category and Toxicity of the SAE symptom reported: http://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx )

Data type

text

Grade/Severity
Description

Grade/Severity

Data type

text

Unexpected?
Description

Unexpected

Data type

boolean

Dose Limiting Toxicity (DLT)
Description

Dose Limiting Toxicity (DLT)

Data type

text

Action Taken
Description

Action Taken

Data type

text

Therapy
Description

Therapy

Data type

text

Protocol Attribution
Description

Protocol Attribution

Data type

text

Detailed Attribution
Description

Detailed Attribution

Data type

text

If Disease, please specify
Description

Specification

Data type

text

If Investigational Treatment, please specify
Description

Specification

Data type

text

If Non-Investigational Treatment, please specify
Description

Specification

Data type

text

If Other, please specify
Description

Specification

Data type

text

Principal Investigator Signature
Description

Principal Investigator Signature

Data type

text

Date
Description

Date

Data type

date

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Similar models

Serious Adverse Event Part II: CRF Wisconsin Madison

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PI Name
Item
PI Name
text
Protocol or IRB Number
Item
Protocol or IRB Number
integer
Protocol Short Title
Item
Protocol Short Title
text
Subject Initials
Item
Subject Initials
text
Subject ID
Item
Subject ID
integer
Item Group
Serious Adverse Event
Item
Report to the IRB
text
Report to the IRB
Code List
Report to the IRB
CL Item
Immediately (1)
CL Item
Next Continuing Review (2)
CL Item
Not Applicable (3)
Course start date
Item
Course start date (Enter date that course of treatment was initiated, if applicable)
date
AE Description/Details
Item
AE Description/Details
text
Category
Item
Category
text
Item
Grade/Severity
text
Grade/Severity
Code List
Grade/Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life Threatening (4)
CL Item
Death (Fatal) (5)
Unexpected
Item
Unexpected?
boolean
Item
Dose Limiting Toxicity (DLT)
text
Dose Limiting Toxicity (DLT)
Code List
Dose Limiting Toxicity (DLT)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Item
Action Taken
text
Action Taken
Code List
Action Taken
CL Item
Dose Reduced (1)
CL Item
Dose Interrupted, then Reduced (2)
CL Item
None (3)
CL Item
Regimen Interrupted (4)
CL Item
Therapy discontinued (5)
CL Item
Not Applicable (leave blank) (6)
Item
Therapy
text
Therapy
Code List
Therapy
CL Item
None (1)
CL Item
Supportive (2)
CL Item
Symptomatic (3)
CL Item
Vigorous Supportive (4)
Item
Protocol Attribution
text
Protocol Attribution
Code List
Protocol Attribution
CL Item
Definite (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Unlikely (4)
CL Item
Unrelated (5)
Item
Detailed Attribution
text
Detailed Attribution
Code List
Detailed Attribution
CL Item
Disease/Condition  (1)
CL Item
Investigational Treatment (2)
CL Item
Non-investigational Treatment (3)
CL Item
Other (4)
Specification
Item
If Disease, please specify
text
Specification
Item
If Investigational Treatment, please specify
text
Specification
Item
If Non-Investigational Treatment, please specify
text
Specification
Item
If Other, please specify
text
Principal Investigator Signature
Item
Principal Investigator Signature
text
Date
Item
Date
date
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