ID

29362

Description

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.

Keywords

  1. 3/20/18 3/20/18 -
Copyright Holder

Roche

Uploaded on

March 20, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Subject Eligibility Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g

Subject Eligibility Screening

SUBJECT ELIGIBILITY (SCREENING)
Description

SUBJECT ELIGIBILITY (SCREENING)

Alias
UMLS CUI-1
C1516637
Subject Number:
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Visit Date:
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Date Subject Signed Informed Consent:
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Did subject meet all eligibility criteria?
Description

eligibility criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
If No, Line Number(s) of Eligibility Criteria Not Met
Description

Eligibility criteria number

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0600091
Details
Description

Details

Data type

text

Alias
UMLS CUI [1]
C1522508
Was a Waiver Granted?
Description

waiver

Data type

boolean

Alias
UMLS CUI [1]
C3827528
If Yes, date:
Description

date protocol deviation

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705236

Similar models

Subject Eligibility Screening

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SUBJECT ELIGIBILITY (SCREENING)
C1516637 (UMLS CUI-1)
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])
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])
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])

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