ID

35804

Beschrijving

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Trefwoorden

Versies (1)
  1. 25/03/2019 25/03/2019 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 mars 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Engels

CRF Tracking/Review Form (TRF)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Investigator
Beschrijving

Investigator Name

Datatype

text

Alias
UMLS CUI [1]
C1320303
CRF Tracking/Review Form
Beschrijving

CRF Tracking/Review Form

Alias
UMLS CUI-1
C3889409
Screening Failure
Beschrijving

Trial Screening; failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0231175
Module
Beschrijving

Module

Datatype

text

Alias
UMLS CUI [1]
C1709061
Module Description
Beschrijving

Module, Description

Datatype

text

Alias
UMLS CUI [1,1]
C1709061
UMLS CUI [1,2]
C0678257
Page Range
Beschrijving

Case Report Form, Page

Datatype

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1704732
Modules
Beschrijving

Module, Status

Datatype

text

Alias
UMLS CUI [1,1]
C1709061
UMLS CUI [1,2]
C0449438
Missing pages (if applicable)
Beschrijving

Case Report Form, Page, Missing

Datatype

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C1705492
Site Monitor’s comments (eg. protocol violations or deviations)
Beschrijving

Case Report Form, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0947611
Signature
Beschrijving

Signature

Alias
UMLS CUI-1
C1519316
Site Monitor’s Name
Beschrijving

Medical Monitor, Name

Datatype

text

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C0027365
Site Monitor’s Signature
Beschrijving

Medical Monitor, Signature

Datatype

text

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1519316
Date Submitted
Beschrijving

Case Report Form, Submission, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1515022
UMLS CUI [1,3]
C0011008
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Similar models

CRF Tracking/Review Form (TRF)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Investigator Name
Item
Investigator
text
C1320303 (UMLS CUI [1])
Item Group
CRF Tracking/Review Form
C3889409 (UMLS CUI-1)
Trial Screening; failed
Item
Screening Failure
boolean
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Module
text
C1709061 (UMLS CUI [1])
Module
Code List
Module
CL Item
MOD1  (1)
CL Item
MOD2  (2)
CL Item
MOD3  (3)
CL Item
MOD4  (4)
CL Item
MOD5  (5)
CL Item
SAE1&2  (6)
CL Item
FORMD1 (7)
Item
Module Description
text
C1709061 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Module, Description
Code List
Module Description
CL Item
Screening to Study Conc.  (1)
CL Item
RLS Rating Scales (2)
CL Item
Patient Scales (3)
CL Item
WPAI Wks 9 - 12 (4)
CL Item
Evening Vst Orthostatic Vitals  (5)
CL Item
Serious Adverse Experiences  (6)
CL Item
Form D (7)
Item
Page Range
text
C1516308 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Case Report Form, Page
Code List
Page Range
CL Item
1-72  (1)
CL Item
79 - 117  (2)
CL Item
118 - 181  (3)
CL Item
182 - 189 (4)
CL Item
190 - 197  (5)
CL Item
73 - 76  (6)
CL Item
77 (7)
Item
Modules
text
C1709061 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Case Report Form, Page
Code List
Modules
CL Item
Sent to DM (1)
CL Item
Unused  (2)
Case Report Form, Page, Missing
Item
Missing pages (if applicable)
text
C1516308 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
Case Report Form, Comment
Item
Site Monitor’s comments (eg. protocol violations or deviations)
text
C1516308 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Signature
C1519316 (UMLS CUI-1)
Medical Monitor, Name
Item
Site Monitor’s Name
text
C1708968 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Medical Monitor, Signature
Item
Site Monitor’s Signature
text
C1708968 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Case Report Form, Submission, Date in time
Item
Date Submitted
date
C1516308 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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