ID
16636
Descrição
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
Palavras-chave
Versões (3)
- 27/07/2016 27/07/2016 -
- 20/11/2016 20/11/2016 -
- 20/06/2018 20/06/2018 - Julian Varghese
Transferido a
27 de julho de 2016
DOI
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Licença
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
Descrição
Deviation Tracking Log
Descrição
#
Tipo de dados
integer
Descrição
Deviation Start Date
Tipo de dados
date
Descrição
Deviation End Date
Tipo de dados
date
Descrição
Deviation Description
Tipo de dados
text
Descrição
1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)
Tipo de dados
text
Descrição
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 dados
text
Descrição
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 dados
text
Descrição
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 dados
text
Descrição
Reported to IRB
Tipo de dados
date
Descrição
Reported to IRB
Tipo de dados
boolean
Descrição
PI Initials
Tipo de dados
text
Descrição
Date of PI Initials
Tipo de dados
date
Similar models
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM