ID

25858

Description

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

Keywords

Versions (1)
  1. 9/22/17 9/22/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 22, 2017

DOI

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License

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)

English

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

1 forms  
General Information
Description

General Information

Center Number
Description

Center Number

Data type

integer

Patient Number
Description

Patient Number

Data type

integer

Patient Initials
Description

Patient Initials

Data type

text

Investigator
Description

Investigator

Data type

text

CRF Tracking Review Form
Description

CRF Tracking Review Form

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

Screening to Study Conc.

Data type

text

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

Screening to Study Conc. missing pages

Data type

integer

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

RLS Rating Scales

Data type

text

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

RLS Rating Scales: missing items

Data type

integer

MOD3: Patient Scales (page 114-146)
Description

Patient Scales

Data type

text

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

Patient Scales (missing pages)

Data type

integer

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

Serious Adverse Experiences

Data type

text

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

Serious Adverse Experiences (missing pages)

Data type

integer

FORMD1: Form D (page 73)
Description

Form D

Data type

text

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

Form D (missing pages)

Data type

integer

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

Site Monitor´s comments

Data type

text

Site Monitor´s Name
Description

Site Monitor´s Name

Data type

text

Site Monitor´s Signature
Description

Site Monitor´s Signature

Data type

text

Date Submitted
Description

Date Submitted

Data type

date

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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