ID

15872

Beschreibung

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Protocol deviation and Investigator Sign off

Stichworte

Versionen (1)
  1. 17-06-16 17-06-16 -
Hochgeladen am

17 juni 2016

DOI

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Creative Commons BY-NC 3.0
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Protocol deviation and Investigator Sign off BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Englisch

Protocol deviation and Investigator Sign off BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulare  
Subject Identification
Beschreibung

Subject Identification

Number of Facility
Beschreibung

Site number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Protocol deviations
Beschreibung

Protocol deviations

Deviation number
Beschreibung

Deviation number

Datentyp

integer

Category Code
Beschreibung

Protocol deviation Category Code

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C2985755
Timed point or visit name (if appropriate)
Beschreibung

Timed point or visit name

Datentyp

text

Alias
UMLS CUI [1]
C2826704
UMLS CUI [2]
C0011008
Deviation
Beschreibung

Protocol deviation

Datentyp

text

Alias
UMLS CUI [1]
C1705236
Action
Beschreibung

Action taken

Datentyp

text

Alias
UMLS CUI [1]
C0441472
Investigator sign off
Beschreibung

Investigator sign off

Investigating physician's signature
Beschreibung

I confirm that the entries on the case report from pages corresonding to this case book accurately and completely represent the results of these examinations, tests and evaluations performed on the dates specified.

Datentyp

text

Alias
UMLS CUI [1]
C0807938
Date of signature
Beschreibung

Date of signature

Datentyp

date

Alias
UMLS CUI [1]
C0807937
Investigating physician (print name)
Beschreibung

Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Protocol deviation and Investigator Sign off BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Protocol deviations
Deviation number
Item
Deviation number
integer
Item
Category Code
integer
C1705236 (UMLS CUI [1,1])
C2985755 (UMLS CUI [1,2])
Protocol deviation Category Code
Code List
Category Code
CL Item
Eligibility Criteria violation (1)
CL Item
All dosing issues including missed partial or incorrect doses as well as non-compliance (2)
CL Item
Prohibited concomitant treatment (3)
CL Item
Evalutation performed outside of acceptable visit window (4)
CL Item
Efficacy evaluation not performed or not valid (5)
CL Item
Safety evaluation not performed or not valid (6)
CL Item
Missed study visit  (7)
CL Item
Other (8)
Timed point or visit name
Item
Timed point or visit name (if appropriate)
text
C2826704 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Protocol deviation
Item
Deviation
text
C1705236 (UMLS CUI [1])
Action taken
Item
Action
text
C0441472 (UMLS CUI [1])
Item Group
Investigator sign off
Investigating physician's signature
Item
Investigating physician's signature
text
C0807938 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C0807937 (UMLS CUI [1])
Investigator
Item
Investigating physician (print name)
text
C2826892 (UMLS CUI [1])
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