ID

38752

Description

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

Keywords

Versions (1)
  1. 10/31/19 10/31/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 31, 2019

DOI

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License

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

English

Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

1 forms  
Pharmacogenetic Research Consent
Description

Pharmacogenetic Research Consent

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

Has informed consent been obtained for PGx-Pharmacogenetic research?

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for GPx-Pharmacogenetic research
Description

Date informed consent obtained for GPx-Pharmacogenetic research

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If no informed consent obtained for Pharmacogenetic research, check reason
Description

If no informed consent obtained for Pharmacogenetic research, check reason

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0392360
If other reason for informed consent not been obtained, specify
Description

If other reason for informed consent not been obtained, specify

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C2348235
UMLS CUI [1,5]
C2348235
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
If a blood sample has been taken, record date sample taken
Description

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

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Pharmacogenetic Research Withdrawal of Consent
Description

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Description

Has subject withdrawn consent for PGx research?

Data type

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Date informed consent withdrawn
Description

Date informed consent withdrawn

Data type

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?
Description

Has a request been made for sample destruction?

Data type

boolean

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

If request for sample destruction has been made, check reason

Data type

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 for sample destruction, specify
Description

If other reason for request for sample destruction, specify

Data type

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]
C0205394
UMLS CUI [1,6]
C2348235
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Similar models

Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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