ID

35641

Description

Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Keywords

Versions (1)
  1. 3/13/19 3/13/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 13, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611

English

Pharmacogenetics

1 forms  
  1. StudyEvent: ODM
    1. Pharmacogenetics
Administrative data
Description

Administrative data

Date of Visit
Description

Visit Date

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Pharmacogenetic (PGx) Research Consent
Description

Pharmacogenetic (PGx) Research Consent

Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

Pharmacogenetic Research Consent

Data type

boolean

Date and Time of Informed Consent
Description

Date and Time of Informed Consent

Data type

datetime

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

blood sample

Data type

boolean

Record the date sample taken
Description

Date Sample Taken

Data type

date

In case of no consent, record the reason
Description

reason for lack of consent

Data type

text

If other, please specify
Description

Specify Other

Data type

text

PGx-Pharmacogenetic Research Consent Withdrawal
Description

PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Data type

boolean

Has a request been made for sample destruction?
Description

Has a request been made for sample destruction?

Data type

boolean

If Yes, enter the reason
Description

If Yes, enter the reason

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Investigator's Signature
Description

Investigator's Signature

By my dated signature below I verify that this case report form accurately displays the results of the examinations, tests, evaluations and treatment noted within.
Description

Investogator's Confirmation

Data type

date

Investigator's signature
Description

Investigator's signature

Data type

text

Investigator's name (Print)
Description

Investigator's name (Print)

Data type

text

Back to the top of the page

Similar models

Pharmacogenetics

1 forms
  1. StudyEvent: ODM
    1. Pharmacogenetics
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Visit Date
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Pharmacogenetic (PGx) Research Consent
Pharmacogenetic Research Consent
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
Date and Time of Informed Consent
Item
Date and Time of Informed Consent
datetime
blood sample
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
Date Sample Taken
Item
Record the date sample taken
date
Item
In case of no consent, record the reason
text
reason for lack of consent
Code List
In case of no consent, record the reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (3)
Specify Other
Item
If other, please specify
text
Item Group
PGx-Pharmacogenetic Research Consent Withdrawal
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
Item
If Yes, enter the reason
text
If Yes, enter the reason
Code List
If Yes, enter the reason
CL Item
Subject requested (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
Item Group
Investigator's Signature
Investogator's Confirmation
Item
By my dated signature below I verify that this case report form accurately displays the results of the examinations, tests, evaluations and treatment noted within.
date
Investigator's signature
Item
Investigator's signature
text
Investigator's name (Print)
Item
Investigator's name (Print)
text
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial