ID
16636
Beschrijving
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
Trefwoorden
Versies (3)
- 27-07-16 27-07-16 -
- 20-11-16 20-11-16 -
- 20-06-18 20-06-18 - Julian Varghese
Geüploaded op
27 juli 2016
DOI
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Licentie
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
Beschrijving
Deviation Tracking Log
Beschrijving
#
Datatype
integer
Beschrijving
Deviation Start Date
Datatype
date
Beschrijving
Deviation End Date
Datatype
date
Beschrijving
Deviation Description
Datatype
text
Beschrijving
1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)
Datatype
text
Beschrijving
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.
Datatype
text
Beschrijving
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.
Datatype
text
Beschrijving
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.
Datatype
text
Beschrijving
Reported to IRB
Datatype
date
Beschrijving
Reported to IRB
Datatype
boolean
Beschrijving
PI Initials
Datatype
text
Beschrijving
Date of PI Initials
Datatype
date
Similar models
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM