ID

27541

Beskrivning

Study Part: Clinical Data Review Form. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Nyckelord

Versioner (1)
  1. 2017-11-19 2017-11-19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Clinical Data Review Form Ropinirole Parkinson Disease 101468/165

Engelsk

Clinical Data Review Form

1 Formulär  
Administrative Documentation
Beskrivning

Administrative Documentation

Alias
UMLS CUI-1
C1320722
To: Data Management @
Beskrivning

Data Management

Datatyp

text

Alias
UMLS CUI [1]
C0011005
Drug ID:
Beskrivning

Drug ID

Datatyp

text

Alias
UMLS CUI [1,1]
C4256366
UMLS CUI [1,2]
C0600091
Protocol No:
Beskrivning

Protocol No

Datatyp

text

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C1711341
Inv.Name/Centre No:
Beskrivning

Centre No

Datatyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Patient No:
Beskrivning

Patient No

Datatyp

text

Alias
UMLS CUI [1]
C1830427
From: Medical Dept. @
Beskrivning

Medical Dept.

Datatyp

text

Alias
UMLS CUI [1]
C1553421
CRF Module(s):
Beskrivning

CRF Module

Datatyp

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1709061
Review comments:
Beskrivning

Review comments:

Alias
UMLS CUI-1
C0947611
1) Serious AE:
Beskrivning

Serious AE

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
AE Text:
Beskrivning

Adverse events

Datatyp

text

Alias
UMLS CUI [1]
C0877248
2) Missing pages:
Beskrivning

Missing pages

Datatyp

boolean

Alias
UMLS CUI [1]
C1548329
To follow:
Beskrivning

To follow

Datatyp

text

Alias
UMLS CUI [1]
C1522577
3) Missing data:
Beskrivning

Missing data

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C1511726
To follow:
Beskrivning

To follow

Datatyp

text

Alias
UMLS CUI [1]
C1522577
Page No:
Beskrivning

Page No

Datatyp

integer

Alias
UMLS CUI [1]
C0237753
Unobtainable:
Beskrivning

Unobtainable

Datatyp

text

Alias
UMLS CUI [1]
C2046401
4) Protocol Violations:
Beskrivning

Protocol Violations

Datatyp

boolean

Alias
UMLS CUI [1]
C1709750
Page No:
Beskrivning

Page No

Datatyp

integer

Alias
UMLS CUI [1,1]
C0814891
UMLS CUI [1,2]
C1704732
5) DRQ replies:
Beskrivning

DRQ replies

Datatyp

text

6) Other comments:
Beskrivning

other

Datatyp

boolean

Alias
UMLS CUI [1]
C0205394
Page No:
Beskrivning

Page No

Datatyp

integer

Alias
UMLS CUI [1,1]
C0814891
UMLS CUI [1,2]
C1704732
Monitor:
Beskrivning

Monitor

Datatyp

text

Alias
UMLS CUI [1]
C1521743
Name:
Beskrivning

Name

Datatyp

text

Alias
UMLS CUI [1]
C0027365
Date of review:
Beskrivning

Date of review

Datatyp

date

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
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Similar models

Clinical Data Review Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Data Management
Item
To: Data Management @
text
C0011005 (UMLS CUI [1])
Drug ID
Item
Drug ID:
text
C4256366 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Protocol No
Item
Protocol No:
text
C3274381 (UMLS CUI [1,1])
C1711341 (UMLS CUI [1,2])
Centre No
Item
Inv.Name/Centre No:
text
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Patient No
Item
Patient No:
text
C1830427 (UMLS CUI [1])
Medical Dept.
Item
From: Medical Dept. @
text
C1553421 (UMLS CUI [1])
CRF Module
Item
CRF Module(s):
text
C1516308 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Item Group
Review comments:
C0947611 (UMLS CUI-1)
Serious AE
Item
1) Serious AE:
boolean
C1519255 (UMLS CUI [1])
Adverse events
Item
AE Text:
text
C0877248 (UMLS CUI [1])
Missing pages
Item
2) Missing pages:
boolean
C1548329 (UMLS CUI [1])
To follow
Item
To follow:
text
C1522577 (UMLS CUI [1])
Missing data
Item
3) Missing data:
boolean
C1705492 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
To follow
Item
To follow:
text
C1522577 (UMLS CUI [1])
Page No
Item
Page No:
integer
C0237753 (UMLS CUI [1])
Unobtainable
Item
Unobtainable:
text
C2046401 (UMLS CUI [1])
Protocol Violations
Item
4) Protocol Violations:
boolean
C1709750 (UMLS CUI [1])
Page No
Item
Page No:
integer
C0814891 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
DRQ replies
Item
5) DRQ replies:
text
other
Item
6) Other comments:
boolean
C0205394 (UMLS CUI [1])
Page No
Item
Page No:
integer
C0814891 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Monitor
Item
Monitor:
text
C1521743 (UMLS CUI [1])
Name
Item
Name:
text
C0027365 (UMLS CUI [1])
Date of review
Item
Date of review:
date
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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