ID

36355

Beschreibung

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Stichworte

Versionen (1)
  1. 06.05.19 06.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. Mai 2019

DOI

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Creative Commons BY-NC 3.0
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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

Englisch

Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

1 Formulare  
Pharmacogenetic Research Consent
Beschreibung

Pharmacogenetic Research Consent

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

Has informed consent been obtained for PGx-Pharmacogenetic research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If informed consent has been obtained, record date informed consent obtained.
Beschreibung

If informed consent has been obtained, record date informed consent obtained.

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
If informed consent has been obtained, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Beschreibung

Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record date sample taken.
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1302413
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
Beschreibung

If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, please specify.
Beschreibung

Other reason for informed consent has not been obtained for PGx-Pharmacogenetic research

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Withdrawal of consent for PGx (DNA) sample destruction
Beschreibung

Withdrawal of consent for PGx (DNA) sample destruction

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C1948029
UMLS CUI-3
C0178913
Has subject withdrawn consent for PGx research?
Beschreibung

Has subject withdrawn consent for PGx research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
If subject has withdrawn consent for PGx research, record date informed consent withdrawn
Beschreibung

If subject has withdrawn consent for PGx research, record date informed consent withdrawn

Datentyp

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Beschreibung

Has a request been made for sample destruction?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for sample destruction check reason
Beschreibung

If a request has been made for sample destruction check reason

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request has been made for sample destruction, please specify
Beschreibung

If other reason for request has been made for sample destruction, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0392360
UMLS CUI [1,6]
C0205394
UMLS CUI [1,7]
C2348235
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Ähnliche Modelle

Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Pharmacogenetic Research Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
If informed consent has been obtained, record date informed consent obtained.
Item
If informed consent has been obtained, record date informed consent obtained.
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Item
If informed consent has been obtained, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date sample taken
Item
If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record date sample taken.
date
C0031328 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
Code List
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
Other reason for informed consent has not been obtained for PGx-Pharmacogenetic research
Item
If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, please specify.
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Withdrawal of consent for PGx (DNA) sample destruction
C1707492 (UMLS CUI-1)
C1948029 (UMLS CUI-2)
C0178913 (UMLS CUI-3)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
If subject has withdrawn consent for PGx research, record date informed consent withdrawn
Item
If subject has withdrawn consent for PGx research, record date informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction check reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
If a request has been made for sample destruction check reason
Code List
If a request has been made for sample destruction check reason
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
If other reason for request has been made for sample destruction, please specify
Item
If other reason for request has been made for sample destruction, please specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,5])
C0205394 (UMLS CUI [1,6])
C2348235 (UMLS CUI [1,7])
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