ID

16674

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

July 31, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Protocol Short Title
Description

Protocol Short Title

Data type

text

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

RE:
Description

RE

Data type

text

Written by
Description

Written by

Data type

text

Date
Description

Date

Data type

date

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

Description of related forms/documents (if applicable)
Description

Description of related forms/documents

Data type

text

Author´s Signature
Description

Author´s Signature

Data type

text

Date
Description

Date

Data type

date

PI´s Signature
Description

PI´s Signature

Data type

text

Date
Description

Date

Data type

date

Back to the top of the page

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
Protocol or IRB Number
Item
Protocol or IRB Number
integer
Protocol Short Title
Item
Protocol Short Title
text
Item Group
Note To File
Applicability
Item
Applicability: Include subject ID(s) if NTF pertains to a particular subject or subjects
boolean
RE
Item
RE:
text
Written by
Item
Written by
text
Date
Item
Date
date
Explanation of Event/Issue
Item
Explanation of Event/Issue
text
Description of related forms/documents
Item
Description of related forms/documents (if applicable)
text
Author´s Signature
Item
Author´s Signature
text
Date
Item
Date
date
PI´s Signature
Item
PI´s Signature
text
Date
Item
Date
date
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial