ID
18776
Descripción
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Deviation/Violation Form. 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
Palabras clave
Versiones (2)
- 27/7/16 27/7/16 -
- 20/11/16 20/11/16 -
Subido en
20 de noviembre de 2016
DOI
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Licencia
Creative Commons BY-NC 3.0
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Subject Deviation/Violation Form: CRF Wisconsin Madison
Subject Deviation/Violation Form: CRF Wisconsin Madison
- StudyEvent: ODM
Descripción
Subject Deviation/Unanticipated Event/Violation
Descripción
Start Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0808070
Descripción
End Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0806020
Descripción
Reported Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302584
Descripción
Reported By
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0700287
Descripción
Description of Deviation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0678257
Descripción
Deviation Category
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0683312
Descripción
Effect on Patient Care
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0017313
- UMLS CUI [1,2]
- C1280500
Descripción
Action Taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0441472
Descripción
Report to the IRB
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0086911
Descripción
Date Reported to the IRB
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C0086911
Descripción
Principal Investigator Signature
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Subject Deviation/Violation Form: CRF Wisconsin Madison
- StudyEvent: ODM
C1521895 (UMLS CUI [1,2])
C1705824 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C1280500 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0086911 (UMLS CUI [1,3])
C1521895 (UMLS CUI [1,2])