ID

25858

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-09-22 2017-09-22 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 september 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

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

1 Formulär  
General Information
Beskrivning

General Information

Center Number
Beskrivning

Center Number

Datatyp

integer

Patient Number
Beskrivning

Patient Number

Datatyp

integer

Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Investigator
Beskrivning

Investigator

Datatyp

text

CRF Tracking Review Form
Beskrivning

CRF Tracking Review Form

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

Screening to Study Conc.

Datatyp

text

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

Screening to Study Conc. missing pages

Datatyp

integer

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

RLS Rating Scales

Datatyp

text

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

RLS Rating Scales: missing items

Datatyp

integer

MOD3: Patient Scales (page 114-146)
Beskrivning

Patient Scales

Datatyp

text

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

Patient Scales (missing pages)

Datatyp

integer

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

Serious Adverse Experiences

Datatyp

text

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

Serious Adverse Experiences (missing pages)

Datatyp

integer

FORMD1: Form D (page 73)
Beskrivning

Form D

Datatyp

text

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

Form D (missing pages)

Datatyp

integer

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

Site Monitor´s comments

Datatyp

text

Site Monitor´s Name
Beskrivning

Site Monitor´s Name

Datatyp

text

Site Monitor´s Signature
Beskrivning

Site Monitor´s Signature

Datatyp

text

Date Submitted
Beskrivning

Date Submitted

Datatyp

date

Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial