ID

26525

Beschrijving

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Trefwoorden

Versies (1)
  1. 18-10-17 18-10-17 -
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18 oktober 2017

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7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

Engels

Investigator Use Part

1 Formulieren  
  1. StudyEvent: ODM
    1. Investigator Use Part
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Investigator Comment Log
Beschrijving

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of Comment
Beschrijving

Date

Datatype

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947611
CRF page number if applicable
Beschrijving

Page Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1516308
UMLS CUI [1,3]
C1515022
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Investigator's Statement
Beschrijving

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Investigator´s Checklist (tick when done)
Beschrijving

Checklist

Datatype

text

Alias
UMLS CUI [1]
C1707357
I certify that the observations and findings are recorded correctly and completely in this CRF.
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Beschrijving

Investigator Signature Date

Datatype

date

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

Investigator Use Part

1 Formulieren
  1. StudyEvent: ODM
    1. Investigator Use Part
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Date
Item
Date of Comment
text
C0011008 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Page Number
Item
CRF page number if applicable
integer
C0237753 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C1515022 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Item
Investigator´s Checklist (tick when done)
text
C1707357 (UMLS CUI [1])
Checklist
Code List
Investigator´s Checklist (tick when done)
CL Item
Check all Adverse Event forms are up to date and complete (Check all Adverse Event forms are up to date and complete)
CL Item
Check that the Concomitant Medication form is up to date (Check that the Concomitant Medication form is up to date)
CL Item
Check that all appropriate pages are signed (thus indicating completion) and dated (Check that all appropriate pages are signed (thus indicating completion) and dated)
CL Item
Check that laboratory results are included (Check that laboratory results are included)
Investigator Signature
Item
I certify that the observations and findings are recorded correctly and completely in this CRF.
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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