ID
16636
Beschreibung
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
Stichworte
Versionen (3)
- 27.07.16 27.07.16 -
- 20.11.16 20.11.16 -
- 20.06.18 20.06.18 - Julian Varghese
Hochgeladen am
27. Juli 2016
DOI
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Lizenz
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
Beschreibung
Deviation Tracking Log
Beschreibung
#
Datentyp
integer
Beschreibung
Deviation Start Date
Datentyp
date
Beschreibung
Deviation End Date
Datentyp
date
Beschreibung
Deviation Description
Datentyp
text
Beschreibung
1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)
Datentyp
text
Beschreibung
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.
Datentyp
text
Beschreibung
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.
Datentyp
text
Beschreibung
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.
Datentyp
text
Beschreibung
Reported to IRB
Datentyp
date
Beschreibung
Reported to IRB
Datentyp
boolean
Beschreibung
PI Initials
Datentyp
text
Beschreibung
Date of PI Initials
Datentyp
date
Ähnliche Modelle
Subject Deviation/Violation Log: CRF Wisconsin Madison
- StudyEvent: ODM