ID

33744

Description

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the PGx-Pharmacogenetic research consent (PGx Consent) form. It has to be filled in for the end of study. This form should only exist once in the study and is conditional upon inclusion of Pharmacogenetics in the protocol.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

English

PGx-Pharmacogenetic research consent (PGx Consent)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

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

PGx-Pharmacogenetic research consent

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

Informed consent for PGx-Pharmacogenetic research

Data type

text

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

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Description

Blood sample collection for PGx-pharmacogenetic (DNA) research

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
If yes, record Date sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Reason for no informed consent for PGx-Pharmacogenetic research
Description

Reason for no informed consent for PGx-Pharmacogenetic research

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
If other reason, please specify
Description

Other Reason for no informed consent for PGx-Pharmacogenetic research

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
UMLS CUI [2]
C0205394
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Similar models

PGx-Pharmacogenetic research consent (PGx Consent)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Informed 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 informed consent
Item
If yes, record date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
text
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Blood sample collection for PGx-pharmacogenetic (DNA) research
Code List
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
CL Item
Yes (Y)
CL Item
No (N)
Date sample taken
Item
If yes, record Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Reason for no informed consent for PGx-Pharmacogenetic research
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
Reason for no informed consent for PGx-Pharmacogenetic research
Code List
Reason for no informed consent for PGx-Pharmacogenetic research
CL Item
Subject declined (1)
CL Item
Subject nos asked by Investigator (2)
CL Item
Other reason (Z)
Other Reason for no informed consent for PGx-Pharmacogenetic research
Item
If other reason, please specify
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2])
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