ID

34036

Description

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Keywords

Versions (2)
  1. 11/9/18 11/9/18 -
  2. 1/11/19 1/11/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 11, 2019

DOI

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License

Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

English

Pharmacogenetics Research Consent Form

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Description

Date of Visit/Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Date of Visit/Assessment
Description

Date of Visit/Assessment

Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
PGx Research Consent
Description

PGx 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
If YES, record date informed consent obtained for PGx-Pharmacogenetic research
Description

If YES, record date informed consent obtained for PGx-Pharmacogenetic research

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
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]
C0005834
UMLS CUI [1,2]
C0031325
If YES, record date sample taken
Description

If YES, record date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031325
If NO informed consent obtained, check reason
Description

If NO informed consent obtained, check reason

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1882120
If Other, specify
Description

If Other, specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Genetics Type
Description

Genetics Type

Data type

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
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Similar models

Pharmacogenetics Research Consent Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
Date
Item
Date
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
PGx 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 YES, record date informed consent obtained for PGx-Pharmacogenetic research
Item
If YES, record date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
Item
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
boolean
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
If YES, record date sample taken
Item
If YES, record date sample taken
date
C1302413 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Item
If NO informed consent obtained, check reason
text
C0392360 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1882120 (UMLS CUI [1,3])
If NO informed consent obtained, check reason
Code List
If NO informed consent obtained, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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