ID

25763

Beschrijving

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Clinical Data Review Form

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Versies (1)
  1. 18-09-17 18-09-17 -
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GlaxoSmithKline

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18 september 2017

DOI

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Creative Commons BY-NC-ND 3.0
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Clinical Data Review Form GSK Ropinirole Restless Legs Syndrome 101468

Engels

Clinical Data Review Form GSK Ropinirole Restless Legs Syndrome 101468

1 Formulieren  
Instructions: Attach a completed Clinical Data Review Form to CRF module sent to Data Management. Use the form to record/clarify and inconsistencies. N.B. The form should remain with the working copy of the CRF modules at all times.
Beschrijving

Instructions: Attach a completed Clinical Data Review Form to CRF module sent to Data Management. Use the form to record/clarify and inconsistencies. N.B. The form should remain with the working copy of the CRF modules at all times.

Alias
UMLS CUI-1
C1442085
To: Data Management @
Beschrijving

Recipient

Datatype

text

Alias
UMLS CUI [1]
C1709854
Drug ID
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1]
C2360065
Protocol No.:
Beschrijving

Protocol Number

Datatype

text

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C1518419
Inv. Name/Centre No:
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient No:
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Form: Medical Dept. @
Beschrijving

Sender

Datatype

text

Alias
UMLS CUI [1]
C1553421
CRF Module(s):
Beschrijving

CRF Module

Datatype

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1709061
Other Data (questionnaires, diary, cards, etc.)
Beschrijving

Other Data

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1511726
Review comments (if more space is needed for any of the following sections, add to Section 6 'Other Comments' below)
Beschrijving

Review comments (if more space is needed for any of the following sections, add to Section 6 'Other Comments' below)

Alias
UMLS CUI-1
C0282443
UMLS CUI-2
C0947611
1) Serious AE
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
1) Serious AE: If 'YES', AE Text:
Beschrijving

Serious Adverse Event: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
2) Missing pages:
Beschrijving

Missing pages

Datatype

boolean

Alias
UMLS CUI [1]
C1548329
2) Missing pages If 'YES', to follow:
Beschrijving

Missing pages: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C1548329
UMLS CUI [1,2]
C2348235
3) Missing data
Beschrijving

Missing data

Datatype

boolean

Alias
UMLS CUI [1]
C0814891
3) Missing data Page No:
Beschrijving

Missing data: Page Number

Datatype

text

Alias
UMLS CUI [1,1]
C0814891
UMLS CUI [1,2]
C1704732
3) Missing data If 'YES', to follow:
Beschrijving

Missing data: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0814891
UMLS CUI [1,2]
C2348235
3) Missing data If 'YES', unobtainable:
Beschrijving

Missing data: Unobtainable

Datatype

text

Alias
UMLS CUI [1]
C2046401
4) Protocol Violations:
Beschrijving

Protocol Violation

Datatype

boolean

Alias
UMLS CUI [1]
C1709750
4) Protocol Violation If 'YES', Page No:
Beschrijving

Protocol Violation: Page Number

Datatype

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1704732
4) Protocol Violations If 'YES', specify:
Beschrijving

Protocol Violation: Specification

Datatype

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
5) DRQ replies:
Beschrijving

DRQ reply

Datatype

text

6) Other comments:
Beschrijving

Comment

Datatype

boolean

Alias
UMLS CUI [1]
C0947611
6) Other comments: If 'YES', Page No:
Beschrijving

Comment: Page Number

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1704732
6) Other comments: If 'YES', specify:
Beschrijving

Comment: Specification

Datatype

text

Alias
UMLS CUI [1]
C2348235
Name
Beschrijving

Investigator's Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date of review:
Beschrijving

Date of review

Datatype

date

Maateenheden
  • dd-mmm-yyyy
dd-mmm-yyyy
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Similar models

Clinical Data Review Form GSK Ropinirole Restless Legs Syndrome 101468

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Instructions: Attach a completed Clinical Data Review Form to CRF module sent to Data Management. Use the form to record/clarify and inconsistencies. N.B. The form should remain with the working copy of the CRF modules at all times.
C1442085 (UMLS CUI-1)
Recipient
Item
To: Data Management @
text
C1709854 (UMLS CUI [1])
Drug Name
Item
Drug ID
text
C2360065 (UMLS CUI [1])
Protocol Number
Item
Protocol No.:
text
C3274381 (UMLS CUI [1,1])
C1518419 (UMLS CUI [1,2])
Centre Number
Item
Inv. Name/Centre No:
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient No:
text
C1830427 (UMLS CUI [1])
Sender
Item
Form: Medical Dept. @
text
C1553421 (UMLS CUI [1])
CRF Module
Item
CRF Module(s):
text
C1516308 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Other Data
Item
Other Data (questionnaires, diary, cards, etc.)
text
C0205394 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Item Group
Review comments (if more space is needed for any of the following sections, add to Section 6 'Other Comments' below)
C0282443 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event
Item
1) Serious AE
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event: Specification
Item
1) Serious AE: If 'YES', AE Text:
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Missing pages
Item
2) Missing pages:
boolean
C1548329 (UMLS CUI [1])
Missing pages: Specification
Item
2) Missing pages If 'YES', to follow:
text
C1548329 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Missing data
Item
3) Missing data
boolean
C0814891 (UMLS CUI [1])
Missing data: Page Number
Item
3) Missing data Page No:
text
C0814891 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Missing data: Specification
Item
3) Missing data If 'YES', to follow:
text
C0814891 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Missing data: Unobtainable
Item
3) Missing data If 'YES', unobtainable:
text
C2046401 (UMLS CUI [1])
Protocol Violation
Item
4) Protocol Violations:
boolean
C1709750 (UMLS CUI [1])
Protocol Violation: Page Number
Item
4) Protocol Violation If 'YES', Page No:
text
C1709750 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Protocol Violation: Specification
Item
4) Protocol Violations If 'YES', specify:
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
DRQ reply
Item
5) DRQ replies:
text
Comment
Item
6) Other comments:
boolean
C0947611 (UMLS CUI [1])
Comment: Page Number
Item
6) Other comments: If 'YES', Page No:
text
C0947611 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Comment: Specification
Item
6) Other comments: If 'YES', specify:
text
C2348235 (UMLS CUI [1])
Investigator's Name
Item
Name
text
C2826892 (UMLS CUI [1])
Date of review
Item
Date of review:
date
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