ID

34846

Beschrijving

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. 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: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the PGx-Pharmacogenetic research form. It has to be filled in for the end of study.

Trefwoorden

Versies (2)
  1. 31-01-19 31-01-19 -
  2. 01-02-19 01-02-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

31 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Engels

PGx-Pharmacogenetic research

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
PGx-Pharmacogenetic research consent
Beschrijving

PGx-Pharmacogenetic research consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Beschrijving

Consent for PGx-Pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If informed consent been obtained for PGx-Pharmacogenetic research, record the date informed consent obtained for PGx-Pharmacogenetic research
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347500
Reason for non consent for PGx-Pharmacogenetic research
Beschrijving

tick one reason

Datatype

integer

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347500
UMLS CUI [2]
C0566251
If other reason for non consent for PGx-Pharmacogenetic research, please specify
Beschrijving

Other reason for non consent for PGx-Pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347500
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0566251
Blood sample collection (DNA)
Beschrijving

Blood sample collection (DNA)

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C2347500
Has a blood sample been collected for PGx-pharmacogenetic research?
Beschrijving

Blood sample collected for PGx-pharmacogenetic research

Datatype

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
Date of blood sample collected for PGx-pharmacogenetic research
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C2347500
Withdrawl of consent
Beschrijving

Withdrawl of consent

Alias
UMLS CUI-1
C1707492
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschrijving

This question must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research.

Datatype

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
Blood sample destruction
Beschrijving

Blood sample destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
Has a request been made for sample destruction?
Beschrijving

This question must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research.

Datatype

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
Reason for request for sample destruction
Beschrijving

Tick one reason

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
If other reason for request for sample destruction, please specify
Beschrijving

Other reason for request for sample destruction

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C1948029
UMLS CUI [1,5]
C0178913
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Similar models

PGx-Pharmacogenetic research

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic research consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Consent for PGx-Pharmacogenetic research
Code List
Has informed consent been obtained for PGx-Pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Date of consent for PGx-Pharmacogenetic research
Item
If informed consent been obtained for PGx-Pharmacogenetic research, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
Item
Reason for non consent for PGx-Pharmacogenetic research
integer
C1298908 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2])
Reason for request for sample destruction
Code List
Reason for non consent for PGx-Pharmacogenetic research
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (3)
Other reason for non consent for PGx-Pharmacogenetic research
Item
If other reason for non consent for PGx-Pharmacogenetic research, please specify
text
C1298908 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0566251 (UMLS CUI [2,2])
Item Group
Blood sample collection (DNA)
C0005834 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
text
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Route, medication
Code List
Has a blood sample been collected for PGx-pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Date of blood sample collected for PGx-pharmacogenetic research
Item
Date of blood sample collected for PGx-pharmacogenetic research
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
Item Group
Withdrawl of consent
C1707492 (UMLS CUI-1)
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
text
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Ongoing medication
Code List
Has subject withdrawn consent for PGx-Pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Blood sample destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Has a request been made for sample destruction?
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Request for sample destruction
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
Reason for request for sample destruction
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
Concomitant medication taken
Code List
Reason for request for sample destruction
CL Item
Subject requested (1)
CL Item
Other (2)
Other reason for request for sample destruction
Item
If other reason for request for sample destruction, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,5])
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