ID

35804

Descripción

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

Palabras clave

Versiones (1)
  1. 25/3/19 25/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de marzo de 2019

DOI

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Licencia

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

Inglés

CRF Tracking/Review Form (TRF)

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Descripción

Study Coordinating Center, Identification number

Tipo de datos

integer

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

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Descripción

Person Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Investigator
Descripción

Investigator Name

Tipo de datos

text

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

CRF Tracking/Review Form

Alias
UMLS CUI-1
C3889409
Screening Failure
Descripción

Trial Screening; failed

Tipo de datos

boolean

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

Module

Tipo de datos

text

Alias
UMLS CUI [1]
C1709061
Module Description
Descripción

Module, Description

Tipo de datos

text

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

Case Report Form, Page

Tipo de datos

text

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

Module, Status

Tipo de datos

text

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

Case Report Form, Page, Missing

Tipo de datos

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)
Descripción

Case Report Form, Comment

Tipo de datos

text

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

Signature

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

Medical Monitor, Name

Tipo de datos

text

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

Medical Monitor, Signature

Tipo de datos

text

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

Case Report Form, Submission, Date in time

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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