ID

22640

Description

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: 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

Versions (1)
  1. 6/8/17 6/8/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 8, 2017

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License

Creative Commons BY-NC 3.0
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SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

English

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

date

Alias
UMLS CUI [1,1]
C1302584
SUBJECT ELIGIBILITY
Description

SUBJECT ELIGIBILITY

Date Subject Signed Protocol Informed Consent:
Description

INFORM_CONSENT_DT

Data type

date

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

If No: • Indicate the line number(s) (from worksheet) of eligibility criteria that was not met • Provide details of the deviation from the specified eligibility criteria • Indicate if waiver was given and the date granted

Data type

integer

Alias
UMLS CUI [1]
C1302261
Eligibility Criteria Not Met
Description

Eligibility Criteria Not Met

Line Number(s) of Eligibility Criteria Not Met (e.g., E-3)
Description

CRIT_NOTMET

Data type

text

Alias
UMLS CUI [1,1]
C1516637
Details
Description

DEVIATION_DETAILS

Data type

text

Alias
UMLS CUI [1,1]
C1555471
UMLS CUI [1,2]
C0566251
Was A Waiver Granted?
Description

APPROVAL

Data type

boolean

Alias
UMLS CUI [1,1]
C1707901
If Yes, Date:
Description

APPROVAL_DT

Data type

date

Alias
UMLS CUI [1,1]
C1707901
UMLS CUI [1,2]
C0011008
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Similar models

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient administration
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
SUBJECT ELIGIBILITY
INFORM_CONSENT_DT
Item
Date Subject Signed Protocol Informed Consent:
date
C2985782 (UMLS CUI [1])
Item
Did subject meet all eligibility criteria?
integer
C1302261 (UMLS CUI [1])
HAND_MOVEMENT_DESC [HDMVTD]
Code List
Did subject meet all eligibility criteria?
CL Item
With Direction (1)
CL Item
Without Direction (2)
Item Group
Eligibility Criteria Not Met
CRIT_NOTMET
Item
Line Number(s) of Eligibility Criteria Not Met (e.g., E-3)
text
C1516637 (UMLS CUI [1,1])
DEVIATION_DETAILS
Item
Details
text
C1555471 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
APPROVAL
Item
Was A Waiver Granted?
boolean
C1707901 (UMLS CUI [1,1])
APPROVAL_DT
Item
If Yes, Date:
date
C1707901 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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