ID
18774
Beschreibung
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Serious Adverse Event Part II. 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 (2)
- 27.07.16 27.07.16 -
- 20.11.16 20.11.16 -
Hochgeladen am
20. November 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Serious Adverse Event Part II: CRF Wisconsin Madison
Serious Adverse Event Part II: CRF Wisconsin Madison
- StudyEvent: ODM
Beschreibung
Serious Adverse Event
Beschreibung
Report to the IRB
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0086911
Beschreibung
Course start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0808070
Beschreibung
AE Description/Details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0678257
Beschreibung
(refer to the Safety Profiler website to search the Category and Toxicity of the SAE symptom reported: http://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx )
Datentyp
text
Alias
- UMLS CUI [1]
- C0683312
Beschreibung
Grade/Severity
Datentyp
text
Alias
- UMLS CUI [1]
- C0441800
- UMLS CUI [2]
- C0439793
Beschreibung
Unexpected
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4055646
Beschreibung
Dose Limiting Toxicity (DLT)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013221
- UMLS CUI [1,2]
- C1512043
Beschreibung
Action Taken
Datentyp
text
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
Therapy
Datentyp
text
Alias
- UMLS CUI [1]
- C0087111
Beschreibung
Protocol Attribution
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0596130
- UMLS CUI [1,2]
- C2348563
Beschreibung
Detailed Attribution
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0596130
- UMLS CUI [1,2]
- C1522508
Beschreibung
Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0949266
- UMLS CUI [1,2]
- C2348235
Beschreibung
Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0949266
- UMLS CUI [1,2]
- C2348235
Beschreibung
Specification
Datentyp
text
Alias
- UMLS CUI [1]
- C2348235
Beschreibung
Principal Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1521895
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Ähnliche Modelle
Serious Adverse Event Part II: CRF Wisconsin Madison
- StudyEvent: ODM
C1521895 (UMLS CUI [1,2])
C1705824 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,2])
C1512043 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1521895 (UMLS CUI [1,2])