ID

29422

Description

Study ID: 102587 Clinical Study ID: EGF102587 Study Title: A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tykerb,Tycerb,Tyverb; Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Breast Documentation part: Consent for PGx-Pharmacogenetic research

Keywords

Versions (1)
  1. 3/22/18 3/22/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 22, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib in Healthy Subjects 102587

English

Consent for PGx-Pharmacogenetic research

1 forms  
Consent for PGx Pharmacogenetic research
Description

Consent for PGx Pharmacogenetic research

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
UMLS CUI-3
C0008976
Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

informed consent for PGx-Pharmacogenetic research

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Description

date informed consent obtained

Data type

date

Alias
UMLS CUI [1]
C2985782
If No, check the reason informed consent not obtained
Description

reason informed consent not obtained

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1882120
UMLS CUI [1,3]
C0392360
If other reason informed consent not obtained, specify
Description

reason informed consent not obtained

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1882120
UMLS CUI [1,3]
C0392360
Has a blood sample been collected for PGx-pharmacogenetic research?
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
If Yes, record the date sample taken
Description

date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Has subject withdrawn consent for PGx-Pharmacogenetic research
Description

withdrawn consent for PGx-Pharmacogenetic research

Data type

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
Has a request been made for sample destruction?
Description

request sample destruction

Data type

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
If Yes, check reason
Description

reason for sample destruction request

Data type

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
If other reason for sample destruction request, specify
Description

reason for sample destruction request

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
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Similar models

Consent for PGx-Pharmacogenetic research

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Consent for PGx Pharmacogenetic research
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
informed consent 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
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2985782 (UMLS CUI [1])
Item
If No, check the reason informed consent not obtained
integer
C0021430 (UMLS CUI [1,1])
C1882120 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason informed consent not obtained
Code List
If No, check the reason informed consent not obtained
CL Item
Subject declined  (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
reason informed consent not obtained
Item
If other reason informed consent not obtained, specify
text
C0021430 (UMLS CUI [1,1])
C1882120 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
blood sample
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1])
date sample taken
Item
If Yes, record the date sample taken
date
C1302413 (UMLS CUI [1])
withdrawn consent for PGx-Pharmacogenetic research
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research
boolean
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
request sample destruction
Item
Has a request been made for sample destruction?
boolean
C0178913 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If Yes, check reason
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for sample destruction request
Code List
If Yes, check reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
reason for sample destruction request
Item
If other reason for sample destruction request, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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