ID

16674

Descripción

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

Palabras clave

  1. 31/7/16 31/7/16 -
  2. 25/11/16 25/11/16 -
  3. 20/9/21 20/9/21 -
Subido en

31 de julio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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Note To File: CRF Wisconsin Madison

Note To File: CRF Wisconsin Madison

Header
Descripción

Header

PI Name
Descripción

PI Name

Tipo de datos

text

Protocol or IRB Number
Descripción

Protocol or IRB Number

Tipo de datos

integer

Protocol Short Title
Descripción

Protocol Short Title

Tipo de datos

text

Note To File
Descripción

Note To File

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

Applicability

Tipo de datos

boolean

RE:
Descripción

RE

Tipo de datos

text

Written by
Descripción

Written by

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Explanation of Event/Issue
Descripción

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).

Tipo de datos

text

Description of related forms/documents (if applicable)
Descripción

Description of related forms/documents

Tipo de datos

text

Author´s Signature
Descripción

Author´s Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

PI´s Signature
Descripción

PI´s Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Similar models

Note To File: CRF Wisconsin Madison

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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