ID

35689

Beschreibung

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the CRF Tracking/ Review Form (TRF) form.

Stichworte

Versionen (2)
  1. 24.08.17 24.08.17 -
  2. 15.03.19 15.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. März 2019

DOI

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Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

Englisch

CRF Tracking/ Review Form (TRF)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschreibung

Centre Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
CRF TRACKING/REVIEW FORM (TRF)
Beschreibung

CRF TRACKING/REVIEW FORM (TRF)

Alias
UMLS CUI-1
C3258859
Investigator
Beschreibung

Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Screening Failure (archive only)
Beschreibung

Screening Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C1512714
MOD1
Beschreibung

Module Description: Enrolment

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
MOD3
Beschreibung

Module Description: Baseline, Day 2, Wk 1-8-Cont/Wthd

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
MOD4
Beschreibung

Module Description: Baseline Patient Rating Scales

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
MOD5
Beschreibung

Module Description: Baseline, Day 2, Wk1-8 RLS Scales

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
SAE1
Beschreibung

Module Description: Serious Adverse Experiences

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
SAE2
Beschreibung

Module Description: Serious Adverse Experiences

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
FORMD
Beschreibung

Module Description: Form D

Datentyp

text

Alias
UMLS CUI [1]
C1709061
Missing pages (if applicable)
Beschreibung

pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
Site Monitor’s comments (eg. protocol violations or deviations)
Beschreibung

comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Site Monitor’s Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Site Monitor’s Signature
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Date Submitted
Beschreibung

Date Submitted

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1515022
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Ähnliche Modelle

CRF Tracking/ Review Form (TRF)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Item Group
CRF TRACKING/REVIEW FORM (TRF)
C3258859 (UMLS CUI-1)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Screening Failure
Item
Screening Failure (archive only)
boolean
C1512714 (UMLS CUI [1])
Item
MOD1
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD1
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD3
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD3
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD4
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD4
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
MOD5
text
C1709061 (UMLS CUI [1])
Module
Code List
MOD5
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
SAE1
text
C1709061 (UMLS CUI [1])
Module
Code List
SAE1
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
SAE2
text
C1709061 (UMLS CUI [1])
Module
Code List
SAE2
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
Item
FORMD
text
C1709061 (UMLS CUI [1])
Module
Code List
FORMD
CL Item
Sent to DM (Sent to DM)
CL Item
Unused (Unused)
pages
Item
Missing pages (if applicable)
text
C1548329 (UMLS CUI [1])
comment
Item
Site Monitor’s comments (eg. protocol violations or deviations)
text
C0947611 (UMLS CUI [1])
Name
Item
Site Monitor’s Name
text
C0027365 (UMLS CUI [1])
Signature
Item
Site Monitor’s Signature
text
C1519316 (UMLS CUI [1])
Date Submitted
Item
Date Submitted
date
C0011008 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
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