ID
16636
Beskrivning
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.
Länk
https://ictr.wisc.edu/CaseReptTempt
Nyckelord
Versioner (3)
- 2016-07-27 2016-07-27 -
- 2016-11-20 2016-11-20 -
- 2018-06-20 2018-06-20 - Julian Varghese
Uppladdad den
27 juli 2016
DOI
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Licens
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
Beskrivning
Deviation Tracking Log
Beskrivning
#
Datatyp
integer
Beskrivning
Deviation Start Date
Datatyp
date
Beskrivning
Deviation End Date
Datatyp
date
Beskrivning
Deviation Description
Datatyp
text
Beskrivning
1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)
Datatyp
text
Beskrivning
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.
Datatyp
text
Beskrivning
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.
Datatyp
text
Beskrivning
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.
Datatyp
text
Beskrivning
Reported to IRB
Datatyp
date
Beskrivning
Reported to IRB
Datatyp
boolean
Beskrivning
PI Initials
Datatyp
text
Beskrivning
Date of PI Initials
Datatyp
date
Similar models
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM