ID

18774

Beskrivning

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.

Länk

https://ictr.wisc.edu/CaseReptTempt

Nyckelord

Versioner (2)
  1. 2016-07-27 2016-07-27 -
  2. 2016-11-20 2016-11-20 -
Uppladdad den

20 november 2016

DOI

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Licens

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

Engelsk

Serious Adverse Event Part II: CRF Wisconsin Madison

1 Formulär  
Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

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

Protocol or IRB Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348563
Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

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

Subject Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Subject ID
Beskrivning

Subject ID

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Serious Adverse Event
Beskrivning

Serious Adverse Event

Report to the IRB
Beskrivning

Report to the IRB

Datatyp

text

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0086911
Course start date (Enter date that course of treatment was initiated, if applicable)
Beskrivning

Course start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0808070
AE Description/Details
Beskrivning

AE Description/Details

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Category
Beskrivning

(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 )

Datatyp

text

Alias
UMLS CUI [1]
C0683312
Grade/Severity
Beskrivning

Grade/Severity

Datatyp

text

Alias
UMLS CUI [1]
C0441800
UMLS CUI [2]
C0439793
Unexpected?
Beskrivning

Unexpected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4055646
Dose Limiting Toxicity (DLT)
Beskrivning

Dose Limiting Toxicity (DLT)

Datatyp

text

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1512043
Action Taken
Beskrivning

Action Taken

Datatyp

text

Alias
UMLS CUI [1]
C2826626
Therapy
Beskrivning

Therapy

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Protocol Attribution
Beskrivning

Protocol Attribution

Datatyp

text

Alias
UMLS CUI [1,1]
C0596130
UMLS CUI [1,2]
C2348563
Detailed Attribution
Beskrivning

Detailed Attribution

Datatyp

text

Alias
UMLS CUI [1,1]
C0596130
UMLS CUI [1,2]
C1522508
If Disease, please specify
Beskrivning

Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
If Investigational Treatment, please specify
Beskrivning

Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C2348235
If Non-Investigational Treatment, please specify
Beskrivning

Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C2348235
If Other, please specify
Beskrivning

Specification

Datatyp

text

Alias
UMLS CUI [1]
C2348235
Principal Investigator Signature
Beskrivning

Principal Investigator Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1521895
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Event Part II: CRF Wisconsin Madison

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Item
Report to the IRB
text
C0684224 (UMLS CUI [1,1])
C0086911 (UMLS CUI [1,2])
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
C0750729 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
AE Description/Details
Item
AE Description/Details
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Category
Item
Category
text
C0683312 (UMLS CUI [1])
Item
Grade/Severity
text
C0441800 (UMLS CUI [1])
C0439793 (UMLS CUI [2])
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
C0877248 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
Item
Dose Limiting Toxicity (DLT)
text
C0013221 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
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
C2826626 (UMLS CUI [1])
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
C0087111 (UMLS CUI [1])
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
C0596130 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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
C0596130 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
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
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Item
If Investigational Treatment, please specify
text
C0949266 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Item
If Non-Investigational Treatment, please specify
text
C0949266 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Item
If Other, please specify
text
C2348235 (UMLS CUI [1])
Principal Investigator Signature
Item
Principal Investigator Signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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