ID

38752

Beschrijving

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Trefwoorden

Versies (1)
  1. 31/10/2019 31/10/2019 -
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GlaxoSmithKline

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31 de outubro de 2019

DOI

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Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

Engels

Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

1 Formulieren  
Pharmacogenetic Research Consent
Beschrijving

Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C0021430 (Informed Consent)
UMLS CUI-2
C2347500 (Pharmacogenetic Test)
Has informed consent been obtained for PGx-Pharmacogenetic research?
Beschrijving

Has informed consent been obtained for PGx-Pharmacogenetic research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430 (Informed Consent)
UMLS CUI [1,2]
C2347500 (Pharmacogenetic Test)
Date informed consent obtained for GPx-Pharmacogenetic research
Beschrijving

Date informed consent obtained for GPx-Pharmacogenetic research

Datatype

date

Alias
UMLS CUI [1,1]
C0021430 (Informed Consent)
UMLS CUI [1,2]
C2347500 (Pharmacogenetic Test)
UMLS CUI [1,3]
C0011008 (Date in time)
SNOMED
410671006
If no informed consent obtained for Pharmacogenetic research, check reason
Beschrijving

If no informed consent obtained for Pharmacogenetic research, check reason

Datatype

text

Alias
UMLS CUI [1,1]
C0021430 (Informed Consent)
UMLS CUI [1,2]
C2347500 (Pharmacogenetic Test)
UMLS CUI [1,3]
C0392360 (Indication of (contextual qualifier))
SNOMED
230165009
LOINC
MTHU008319
If other reason for informed consent not been obtained, specify
Beschrijving

If other reason for informed consent not been obtained, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0021430 (Informed Consent)
UMLS CUI [1,2]
C2347500 (Pharmacogenetic Test)
UMLS CUI [1,3]
C0392360 (Indication of (contextual qualifier))
SNOMED
230165009
LOINC
MTHU008319
UMLS CUI [1,4]
C2348235 (Specification)
UMLS CUI [1,5]
C2348235 (Specification)
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500 (Pharmacogenetic Test)
UMLS CUI [1,2]
C0005834 (Collection of blood specimen for laboratory procedure)
SNOMED
82078001
LOINC
LP125037-4
If a blood sample has been taken, record date sample taken
Beschrijving

If a blood sample has been taken, record date sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C2347500 (Pharmacogenetic Test)
UMLS CUI [1,2]
C0005834 (Collection of blood specimen for laboratory procedure)
SNOMED
82078001
LOINC
LP125037-4
UMLS CUI [1,3]
C0011008 (Date in time)
SNOMED
410671006
Pharmacogenetic Research Withdrawal of Consent
Beschrijving

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492 (Consent Withdrawn)
UMLS CUI-2
C0031325 (Pharmacogenetics)
Has subject withdrawn consent for PGx research?
Beschrijving

Has subject withdrawn consent for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707492 (Consent Withdrawn)
UMLS CUI [1,2]
C0031325 (Pharmacogenetics)
Date informed consent withdrawn
Beschrijving

Date informed consent withdrawn

Datatype

date

Alias
UMLS CUI [1,1]
C1707492 (Consent Withdrawn)
UMLS CUI [1,2]
C0031325 (Pharmacogenetics)
UMLS CUI [1,3]
C0011008 (Date in time)
SNOMED
410671006
Has a request been made for sample destruction?
Beschrijving

Has a request been made for sample destruction?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948029 (Destruction (action))
UMLS CUI [1,2]
C0178913 (Blood specimen)
SNOMED
119297000
UMLS CUI [1,3]
C1272683 (Request - action)
SNOMED
385644000
If request for sample destruction has been made, check reason
Beschrijving

If request for sample destruction has been made, check reason

Datatype

text

Alias
UMLS CUI [1,1]
C1948029 (Destruction (action))
UMLS CUI [1,2]
C0178913 (Blood specimen)
SNOMED
119297000
UMLS CUI [1,3]
C1272683 (Request - action)
SNOMED
385644000
UMLS CUI [1,4]
C0392360 (Indication of (contextual qualifier))
SNOMED
230165009
LOINC
MTHU008319
If other reason for request for sample destruction, specify
Beschrijving

If other reason for request for sample destruction, specify

Datatype

text

Alias
UMLS CUI [1,1]
C1948029 (Destruction (action))
UMLS CUI [1,2]
C0178913 (Blood specimen)
SNOMED
119297000
UMLS CUI [1,3]
C1272683 (Request - action)
SNOMED
385644000
UMLS CUI [1,4]
C0392360 (Indication of (contextual qualifier))
SNOMED
230165009
LOINC
MTHU008319
UMLS CUI [1,5]
C0205394 (Other)
SNOMED
74964007
LOINC
LP21049-9
UMLS CUI [1,6]
C2348235 (Specification)
Terug naar het begin van de pagina

Similar models

Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Date informed consent obtained for GPx-Pharmacogenetic research
Item
Date informed consent obtained for GPx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If no informed consent obtained for Pharmacogenetic research, check reason
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If no informed consent obtained for Pharmacogenetic research, check reason
Code List
If no informed consent obtained for Pharmacogenetic research, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
If other reason for informed consent not been obtained, specify
Item
If other reason for informed consent not been obtained, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
If a blood sample has been taken, record date sample taken
Item
If a blood sample has been taken, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
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])
Date informed consent withdrawn
Item
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 request for sample destruction has been made, check reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
If request for sample destruction has been made, check reason
Code List
If request for sample destruction has been made, 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 for sample destruction, specify
Item
If other reason for request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Terug naar het begin van de pagina 

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