ID

18747

Beschreibung

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Adverse Event Tracking Log. 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

Stichworte

Versionen (2)
  1. 27.07.16 27.07.16 -
  2. 18.11.16 18.11.16 -
Hochgeladen am

18. November 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Adverse Event Tracking Log: CRF Wisconsin Madison

Englisch

Adverse Event Tracking Log: CRF Wisconsin Madison

1 Formulare  
Header
Beschreibung

Header

PI Name
Beschreibung

PI Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Protocol or IRB Number
Beschreibung

Protocol or IRB Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348563
Protocol Short Title
Beschreibung

Protocol Short Title

Datentyp

text

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

Subject Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Subject ID
Beschreibung

Subject ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Number of Page
Beschreibung

Number of Page

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0449788
Total Number of Pages
Beschreibung

Total Number of Pages

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0449788
Adverse Event Tracking Log
Beschreibung

Adverse Event Tracking Log

#
Beschreibung

#

Datentyp

integer

Date Reported
Beschreibung

Date Reported

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1521800
Adverse Event Description
Beschreibung

Adverse Event Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0877248
Adverse Event Category
Beschreibung

Adverse Event Category

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0683312
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Outcome
Beschreibung

0= Fatal 1= Not recovered/not resolved 2= Recovered w/sequelae 3= Recovered w/o sequelae 4= Recovering/Resolving

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Severity / Grade
Beschreibung

1= Mild 2= Moderate 3= Severe 4= Life threatening 5= Fatal

Datentyp

text

Alias
UMLS CUI [1]
C0439793
UMLS CUI [2]
C0441800
Serious
Beschreibung

Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0205404
Expected
Beschreibung

Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C1517001
AE Treatment
Beschreibung

0= None 1= Medication(s) 2= Non-medication TX

Datentyp

text

Alias
UMLS CUI [1]
C2981656
Action Taken
Beschreibung

0= None 1= Interrupted 2= Discontinued 3= Dose reduced 4= Dose increased 5= Not Applicable

Datentyp

text

Alias
UMLS CUI [1]
C2826626
Attribution
Beschreibung

0= Definite 1= Probable 2= Unlikely 3= Unrelated

Datentyp

text

Alias
UMLS CUI [1]
C1706735
PI Initials
Beschreibung

PI Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1521895
UMLS CUI [1,2]
C2986440
Date of PI Initials
Beschreibung

Date of PI Initials

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C2986440
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Ähnliche Modelle

Adverse Event Tracking Log: CRF Wisconsin Madison

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1])
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])
Number of Page
Item
Number of Page
integer
C1704732 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Total Number of Pages
Item
Total Number of Pages
integer
C1704732 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Adverse Event Tracking Log
#
Item
#
integer
Date Reported
Item
Date Reported
date
C0011008 (UMLS CUI [1,1])
C1521800 (UMLS CUI [1,2])
Adverse Event Description
Item
Adverse Event Description
text
C0678257 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event Category
Item
Adverse Event Category
text
C0877248 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Severity / Grade
Item
Severity / Grade
text
C0439793 (UMLS CUI [1])
C0441800 (UMLS CUI [2])
Serious
Item
Serious
boolean
C0205404 (UMLS CUI [1])
Expected
Item
Expected
boolean
C1517001 (UMLS CUI [1])
AE Treatment
Item
AE Treatment
text
C2981656 (UMLS CUI [1])
Action Taken
Item
Action Taken
text
C2826626 (UMLS CUI [1])
Attribution
Item
Attribution
text
C1706735 (UMLS CUI [1])
PI Initials
Item
PI Initials
text
C1521895 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of PI Initials
Item
Date of PI Initials
date
C0011008 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])
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