ID

40498

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 4/27/20 4/27/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 27, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

English

Screening - Investigator's Statement

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Investigator's Statement
Description

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Check that all appropriate pages are signed (thus indicating completion) and dated
Description

Check that all appropriate pages are signed (thus indicating completion) and dated

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1519316
UMLS CUI [2,1]
C1704732
UMLS CUI [2,2]
C0011008
Check that laboratory results are included
Description

Check that laboratory results are included

Data type

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0920316
Investigator's Signature
Description

I certify that the observations and findings are recorded correctly and completely in this CRF.

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Description

Investigator's Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Screening - Investigator's Statement

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
integer
C1704732 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1704732 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Check that all appropriate pages are signed (thus indicating completion) and dated
Code List
Check that all appropriate pages are signed (thus indicating completion) and dated
CL Item
Tick, when done (1)
Item
Check that laboratory results are included
integer
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Check that laboratory results are included
Code List
Check that laboratory results are included
CL Item
Tick when done (1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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