ID

25038

Description

Study part: CRF Tracking/ Review Form (TRF). 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. 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. Study ID: 101468/192. Clinical Study ID: 101468/192

Keywords

Versions (2)
  1. 8/24/17 8/24/17 -
  2. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2017

DOI

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License

Creative Commons BY-NC 3.0
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CRF Tracking/ Review Form (TRF) Ropinirole Restless Legs Syndrom 101468/192

English

CRF Tracking/ Review Form (TRF)

1 forms  
CRF TRACKING/REVIEW FORM (TRF)
Description

CRF TRACKING/REVIEW FORM (TRF)

Alias
UMLS CUI-1
C3258859
Centre Number
Description

Centre Number

Data type

integer

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

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Investigator
Description

Investigator

Data type

text

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

Screening Failure

Data type

boolean

Alias
UMLS CUI [1]
C1512714
MOD1
Description

Module Description: Enrolment

Data type

text

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

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD3
Description

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

Data type

text

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

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD4
Description

Module Description: Baseline Patient Rating Scales

Data type

text

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

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
MOD5
Description

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

Data type

text

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

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
SAE1
Description

Module Description: Serious Adverse Experiences

Data type

text

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

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
SAE2
Description

Module Description: Serious Adverse Experiences

Data type

text

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

pages

Data type

text

Alias
UMLS CUI [1]
C1548329
FORMD
Description

Module Description: Form D

Data type

text

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

pages

Data type

text

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

comment

Data type

text

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

Name

Data type

text

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

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date Submitted
Description

Date Submitted

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1515022
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Similar models

CRF Tracking/ Review Form (TRF)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CRF TRACKING/REVIEW FORM (TRF)
C3258859 (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])
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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