ID

36914

Beschrijving

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This documen contains the Laboratory Collections for Screening form.

Trefwoorden

Versies (2)
  1. 01-09-17 01-09-17 -
  2. 21-06-19 21-06-19 -
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GlaxoSmithKline

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21 juni 2019

DOI

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Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Engels

Laboratory Collections for Screening

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschrijving

identification number

Datatype

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Clinical chemistry and haematology
Beschrijving

Clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date of blood sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Comments:
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschrijving

laboratory findings blood sampling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0005834
Urinalysis
Beschrijving

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of urine sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of urine sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Comments:
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschrijving

If ‘Yes’, please record diagnosis on Baseline Signs and Symptoms page.

Datatype

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042014
Drug Screening (Urine)
Beschrijving

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Date of urine sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of urine sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Were there any contra-indicated drugs detected?
Beschrijving

If ‘Yes’, please withdraw subject and record all the relevant contra-indicated drugs below.

Datatype

text

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
Type of Drug
Beschrijving

Type of Drug

Datatype

text

Alias
UMLS CUI [1]
C0457591
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
HIV and Hepatitis B and C
Beschrijving

HIV and Hepatitis B and C

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0019163
UMLS CUI-3
C0019196
Date of blood sampling
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Comments:
Beschrijving

If positive please withdraw the subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0947611
Pregnancy test
Beschrijving

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Beschrijving

Pregnancy test performance

Datatype

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1518965
If tes was not performed, please specify reason
Beschrijving

No test performance, reason

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
Date of sample
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Time of sample
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0032976
Pregnancy test result
Beschrijving

Pregnancy test result

Datatype

text

Alias
UMLS CUI [1]
C0427777
Dipstick urine HCG
Beschrijving

Dipstick urine HCG

Datatype

text

Alias
UMLS CUI [1]
C1254846
Serum HCG
Beschrijving

Serum HCG

Datatype

text

Alias
UMLS CUI [1]
C2348195
If other pregnancy test types, please specify
Beschrijving

Other pregnancy test types

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0332307
Laboratory name, if applicable
Beschrijving

Laboratory name

Datatype

text

Alias
UMLS CUI [1]
C0022877
Alcohol test
Beschrijving

Alcohol test

Alias
UMLS CUI-1
C0202304
Date of sample
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Time of sample
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0032976
Alcohol test finding
Beschrijving

Alcohol test finding

Datatype

text

Alias
UMLS CUI [1]
C0495718
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Similar models

Laboratory Collections for Screening

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
laboratory findings blood sampling
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
boolean
C0022877 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0022877 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
laboratory findings urinalysis
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Date of urine sampling
Item
Date of urine sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urine sampling
Item
Time of urine sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Were there any contra-indicated drugs detected?
text
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
contraindication drugs
Code List
Were there any contra-indicated drugs detected?
CL Item
Yes (Y)
CL Item
No (N)
Type of Drug
Item
Type of Drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
HIV and Hepatitis B and C
C0019682 (UMLS CUI-1)
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test carried out?
text
C0032976 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Pregnancy test performance
Code List
Was a pregnancy test carried out?
CL Item
Yes (Y)
CL Item
No (N)
No test performance, reason
Item
If tes was not performed, please specify reason
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
Date of sample
Item
Date of sample
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Pregnancy test result
text
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Dipstick urine HCG
text
C1254846 (UMLS CUI [1])
Pregnancy test result
Code List
Dipstick urine HCG
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Serum HCG
text
C2348195 (UMLS CUI [1])
Pregnancy test result
Code List
Serum HCG
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Other pregnancy test types
Item
If other pregnancy test types, please specify
text
C0205394 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name, if applicable
text
C0022877 (UMLS CUI [1])
Item Group
Alcohol test
C0202304 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Alcohol test finding
text
C0495718 (UMLS CUI [1])
Pregnancy test result
Code List
Alcohol test finding
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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