ID

27542

Beskrivning

Study Part: Investigator’s Statement Follow-Up. 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. 2017-11-20 2017-11-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Investigator’s Statement Follow-Up Ropinirole Parkinson Disease 101468/165

Engelsk

Investigator’s Statement Follow-Up

1 Formulär  
INVESTIGATOR’S STATEMENT
Beskrivning

INVESTIGATOR’S STATEMENT

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Check all Adverse Event forms are up to date and complete
Beskrivning

Adverse Event

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Check that the Concomitant Medication form is up to date
Beskrivning

Concomitant Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Check that all appropriate pages are signed (thus indicating completion) and dated
Beskrivning

consent

Datatyp

boolean

Alias
UMLS CUI [1]
C1511481
Check that laboratory results are included
Beskrivning

laboratory results

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
I certify that the observations and findings are recorded correctly and completely in this CRF.
Beskrivning

complete

Datatyp

boolean

Alias
UMLS CUI [1]
C0205197
Investigator:
Beskrivning

Investigator

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date:
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Investigator’s Statement Follow-Up

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
INVESTIGATOR’S STATEMENT
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Adverse Event
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1])
Concomitant Medication
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1])
consent
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C1511481 (UMLS CUI [1])
laboratory results
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1])
complete
Item
I certify that the observations and findings are recorded correctly and completely in this CRF.
boolean
C0205197 (UMLS CUI [1])
Investigator
Item
Investigator:
text
C2826892 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])
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