ID
16636
Description
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
Keywords
Versions (3)
- 7/27/16 7/27/16 -
- 11/20/16 11/20/16 -
- 6/20/18 6/20/18 - Julian Varghese
Uploaded on
July 27, 2016
DOI
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License
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
Description
Deviation Tracking Log
Description
#
Data type
integer
Description
Deviation Start Date
Data type
date
Description
Deviation End Date
Data type
date
Description
Deviation Description
Data type
text
Description
1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)
Data type
text
Description
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.
Data type
text
Description
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.
Data type
text
Description
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.
Data type
text
Description
Reported to IRB
Data type
date
Description
Reported to IRB
Data type
boolean
Description
PI Initials
Data type
text
Description
Date of PI Initials
Data type
date
Similar models
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM