ID
18747
Beschreibung
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Adverse Event Tracking 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 (2)
- 27.07.16 27.07.16 -
- 18.11.16 18.11.16 -
Hochgeladen am
18. November 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Adverse Event Tracking Log: CRF Wisconsin Madison
Adverse Event Tracking Log: CRF Wisconsin Madison
- StudyEvent: ODM
Beschreibung
Adverse Event Tracking Log
Beschreibung
#
Datentyp
integer
Beschreibung
Date Reported
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1521800
Beschreibung
Adverse Event Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0877248
Beschreibung
Adverse Event Category
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0683312
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
0= Fatal 1= Not recovered/not resolved 2= Recovered w/sequelae 3= Recovered w/o sequelae 4= Recovering/Resolving
Datentyp
text
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
1= Mild 2= Moderate 3= Severe 4= Life threatening 5= Fatal
Datentyp
text
Alias
- UMLS CUI [1]
- C0439793
- UMLS CUI [2]
- C0441800
Beschreibung
Serious
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205404
Beschreibung
Expected
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517001
Beschreibung
0= None 1= Medication(s) 2= Non-medication TX
Datentyp
text
Alias
- UMLS CUI [1]
- C2981656
Beschreibung
0= None 1= Interrupted 2= Discontinued 3= Dose reduced 4= Dose increased 5= Not Applicable
Datentyp
text
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
0= Definite 1= Probable 2= Unlikely 3= Unrelated
Datentyp
text
Alias
- UMLS CUI [1]
- C1706735
Beschreibung
PI Initials
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1521895
- UMLS CUI [1,2]
- C2986440
Beschreibung
Date of PI Initials
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1521895
- UMLS CUI [1,3]
- C2986440
Ähnliche Modelle
Adverse Event Tracking Log: CRF Wisconsin Madison
- StudyEvent: ODM
C1705824 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C1521800 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,2])
C0441800 (UMLS CUI [2])
C2986440 (UMLS CUI [1,2])
C1521895 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])