ID
16636
Descripción
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Deviation/Violation 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
Palabras clave
Versiones (3)
- 27/7/16 27/7/16 -
- 20/11/16 20/11/16 -
- 20/6/18 20/6/18 - Julian Varghese
Subido en
27 de julio de 2016
DOI
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Licencia
Creative Commons BY-NC 3.0
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Subject Deviation/Violation Log: CRF Wisconsin Madison
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM
Descripción
Deviation Tracking Log
Descripción
#
Tipo de datos
integer
Descripción
Deviation Start Date
Tipo de datos
date
Descripción
Deviation End Date
Tipo de datos
date
Descripción
Deviation Description
Tipo de datos
text
Descripción
1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)
Tipo de datos
text
Descripción
If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information.
Tipo de datos
text
Descripción
If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information.
Tipo de datos
text
Descripción
If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information.
Tipo de datos
text
Descripción
Reported to IRB
Tipo de datos
date
Descripción
Reported to IRB
Tipo de datos
boolean
Descripción
PI Initials
Tipo de datos
text
Descripción
Date of PI Initials
Tipo de datos
date
Similar models
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM