ID

36026

Beschreibung

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up.

Stichworte

Versionen (1)
  1. 09.04.19 09.04.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. April 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Englisch

Investigator's Check list

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschreibung

Subject No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschreibung

Panel ID

Datentyp

text

Alias
UMLS CUI [1]
C3846158
Investigators checklist
Beschreibung

Investigators checklist

Alias
UMLS CUI-1
C1707357
UMLS CUI-2
C0008961
Check all Adverse Event forms are up to date and complete
Beschreibung

Tick when done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0205197
Check that the Concomitant Medication form is up to date
Beschreibung

Tick when done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0237400
Check that all appropriate pages are signed (thus indicating completion) and dated
Beschreibung

Tick when done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C1519316
Check that laboratory results are included
Beschreibung

Tick when done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0920316
Signature Principal Investigator
Beschreibung

I certify that the observations and findings are recorded correctly and completely in this CRF.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

I certify that the observations and findings are recorded correctly and completely in this CRF. day/month/year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Investigator's Check list

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item Group
Investigators checklist
C1707357 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
Check Adverse Event forms
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Check Concomitant Medication form
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
Check signatures
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C1283174 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Check laboratory results
Item
Check that laboratory results are included
boolean
C1283174 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
Signature Principal Investigator
Item
Signature Principal Investigator
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video