ID
18776
Beschrijving
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
Trefwoorden
Versies (2)
- 27-07-16 27-07-16 -
- 20-11-16 20-11-16 -
Geüploaded op
20 november 2016
DOI
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Licentie
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
Beschrijving
Subject Deviation/Unanticipated Event/Violation
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Reported Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302584
Beschrijving
Reported By
Datatype
text
Alias
- UMLS CUI [1]
- C0700287
Beschrijving
Description of Deviation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0678257
Beschrijving
Deviation Category
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0683312
Beschrijving
Effect on Patient Care
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017313
- UMLS CUI [1,2]
- C1280500
Beschrijving
Action Taken
Datatype
text
Alias
- UMLS CUI [1]
- C0441472
Beschrijving
Report to the IRB
Datatype
text
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0086911
Beschrijving
Date Reported to the IRB
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C0086911
Beschrijving
Principal Investigator Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Beschrijving
Date
Datatype
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])
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