Information:
Fel:
ID
29362
Beskrivning
Study part: Subject Eligibility Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.
Nyckelord
Versioner (1)
- 2018-03-20 2018-03-20 -
Rättsinnehavare
Roche
Uppladdad den
20 mars 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Subject Eligibility Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g
Subject Eligibility Screening
- StudyEvent: ODM
Similar models
Subject Eligibility Screening
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of visit
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Date Subject Signed Informed Consent:
date
C2985782 (UMLS CUI [1])
eligibility criteria
Item
Did subject meet all eligibility criteria?
boolean
C1516637 (UMLS CUI [1])
Eligibility criteria number
Item
If No, Line Number(s) of Eligibility Criteria Not Met
text
C1516637 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Details
Item
Details
text
C1522508 (UMLS CUI [1])
waiver
Item
Was a Waiver Granted?
boolean
C3827528 (UMLS CUI [1])
date protocol deviation
Item
If Yes, date:
date
C0011008 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,2])