ID

25858

Beschrijving

Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) 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

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Versies (1)
  1. 22-09-17 22-09-17 -
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GlaxoSmithKline

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22 september 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 CRF Tracking/Review Form (Form 24)

Engels

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 CRF Tracking/Review Form (Form 24)

1 Formulieren  
General Information
Beschrijving

General Information

Center Number
Beschrijving

Center Number

Datatype

integer

Patient Number
Beschrijving

Patient Number

Datatype

integer

Patient Initials
Beschrijving

Patient Initials

Datatype

text

Investigator
Beschrijving

Investigator

Datatype

text

CRF Tracking Review Form
Beschrijving

CRF Tracking Review Form

MOD1: Screening to Study Conc. (Page 1-68)
Beschrijving

Screening to Study Conc.

Datatype

text

MOD1: Screening to Study Conc. (Page 1-68): Missing pages (if applicable)
Beschrijving

Screening to Study Conc. missing pages

Datatype

integer

MOD2: RLS Rating Scales (page 75-113)
Beschrijving

RLS Rating Scales

Datatype

text

MOD2: RLS Rating Scales (page 75-113): Missing pages (if applicable)
Beschrijving

RLS Rating Scales: missing items

Datatype

integer

MOD3: Patient Scales (page 114-146)
Beschrijving

Patient Scales

Datatype

text

MOD3: Patient Scales (page 114-146): missing pages (if applicable)
Beschrijving

Patient Scales (missing pages)

Datatype

integer

SAE1&2: Serious Adverse Experiences (pages 69-72)
Beschrijving

Serious Adverse Experiences

Datatype

text

SAE1&2: Serious Adverse Experiences (pages 69-72): missing pages (if applicable)
Beschrijving

Serious Adverse Experiences (missing pages)

Datatype

integer

FORMD1: Form D (page 73)
Beschrijving

Form D

Datatype

text

FORMD1: Form D (page 73): missing pages (if applicable)
Beschrijving

Form D (missing pages)

Datatype

integer

Site Monitor´s comments (e.g. protocol violations or deviations)
Beschrijving

Site Monitor´s comments

Datatype

text

Site Monitor´s Name
Beschrijving

Site Monitor´s Name

Datatype

text

Site Monitor´s Signature
Beschrijving

Site Monitor´s Signature

Datatype

text

Date Submitted
Beschrijving

Date Submitted

Datatype

date

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 CRF Tracking/Review Form (Form 24)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General Information
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Investigator
Item
Investigator
text
Item Group
CRF Tracking Review Form
Item
MOD1: Screening to Study Conc. (Page 1-68)
text
Screening to Study Conc.
Code List
MOD1: Screening to Study Conc. (Page 1-68)
CL Item
Sent to DM (1)
CL Item
Unused (2)
Screening to Study Conc. missing pages
Item
MOD1: Screening to Study Conc. (Page 1-68): Missing pages (if applicable)
integer
Item
MOD2: RLS Rating Scales (page 75-113)
text
RLS Rating Scales
Code List
MOD2: RLS Rating Scales (page 75-113)
CL Item
Send to DM (1)
CL Item
Unused (2)
RLS Rating Scales: missing items
Item
MOD2: RLS Rating Scales (page 75-113): Missing pages (if applicable)
integer
Item
MOD3: Patient Scales (page 114-146)
text
Patient Scales
Code List
MOD3: Patient Scales (page 114-146)
CL Item
Sent to DM (1)
CL Item
Unused (2)
Patient Scales (missing pages)
Item
MOD3: Patient Scales (page 114-146): missing pages (if applicable)
integer
Item
SAE1&2: Serious Adverse Experiences (pages 69-72)
text
Serious Adverse Experiences
Code List
SAE1&2: Serious Adverse Experiences (pages 69-72)
CL Item
Sent to DM (1)
CL Item
Unused (2)
Serious Adverse Experiences (missing pages)
Item
SAE1&2: Serious Adverse Experiences (pages 69-72): missing pages (if applicable)
integer
Item
FORMD1: Form D (page 73)
text
Form D
Code List
FORMD1: Form D (page 73)
CL Item
Sent to DM (1)
CL Item
Unused (2)
Form D (missing pages)
Item
FORMD1: Form D (page 73): missing pages (if applicable)
integer
Site Monitor´s comments
Item
Site Monitor´s comments (e.g. protocol violations or deviations)
text
Site Monitor´s Name
Item
Site Monitor´s Name
text
Site Monitor´s Signature
Item
Site Monitor´s Signature
text
Date Submitted
Item
Date Submitted
date
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