ID

43787

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Note To File. 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 (3)
  1. 7/31/16 7/31/16 -
  2. 11/25/16 11/25/16 -
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Note To File: CRF Wisconsin Madison

English

Note To File: 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
Note To File
Description

Note To File

Applicability: Include subject ID(s) if NTF pertains to a particular subject or subjects
Description

Applicability

Data type

boolean

Alias
UMLS CUI [1]
C2826694
RE:
Description

RE

Data type

text

Written by
Description

Written by

Data type

text

Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Explanation of Event/Issue
Description

Description of the issue/process/problem being documented , including (if applicable) how, when, and by whom the issue was identified, cause of issue (if known), corrective and preventive actions taken (when and by whom).

Data type

text

Alias
UMLS CUI [1,1]
C0681841
UMLS CUI [1,2]
C0441471
Description of related forms/documents (if applicable)
Description

Description of related forms/documents

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1301746
Author´s Signature
Description

Author´s Signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C3812881
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
PI´s Signature
Description

PI Signature

Data type

text

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Note To File: 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])
Item Group
Note To File
Applicability
Item
Applicability: Include subject ID(s) if NTF pertains to a particular subject or subjects
boolean
C2826694 (UMLS CUI [1])
RE
Item
RE:
text
Written by
Item
Written by
text
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Explanation of Event/Issue
Item
Explanation of Event/Issue
text
C0681841 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
Description of related forms/documents
Item
Description of related forms/documents (if applicable)
text
C0678257 (UMLS CUI [1,1])
C1301746 (UMLS CUI [1,2])
Author´s Signature
Item
Author´s Signature
text
C1519316 (UMLS CUI [1,1])
C3812881 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
PI Signature
Item
PI´s Signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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