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.

Lien

https://ictr.wisc.edu/CaseReptTempt

Mots-clés

  1. 31/07/2016 31/07/2016 -
  2. 25/11/2016 25/11/2016 -
  3. 20/09/2021 20/09/2021 -
Téléchargé le

31 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Note To File: CRF Wisconsin Madison

Note To File: CRF Wisconsin Madison

Header
Description

Header

PI Name
Description

PI Name

Type de données

text

Protocol or IRB Number
Description

Protocol or IRB Number

Type de données

integer

Protocol Short Title
Description

Protocol Short Title

Type de données

text

Note To File
Description

Note To File

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

Applicability

Type de données

boolean

RE:
Description

RE

Type de données

text

Written by
Description

Written by

Type de données

text

Date
Description

Date

Type de données

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).

Type de données

text

Description of related forms/documents (if applicable)
Description

Description of related forms/documents

Type de données

text

Author´s Signature
Description

Author´s Signature

Type de données

text

Date
Description

Date

Type de données

date

PI´s Signature
Description

PI´s Signature

Type de données

text

Date
Description

Date

Type de données

date

Similar models

Note To File: CRF Wisconsin Madison

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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

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