ID

20664

Description

Documentation Part: Pharmacogenetic (PGx) Research An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Keywords

Versions (1)
  1. 3/9/17 3/9/17 -
Uploaded on

March 9, 2017

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.

Pharmacogenetic (PGx) Research Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

English

Pharmacogenetic (PGx) Research Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms  
Subject information
Description

Subject information

Alias
UMLS CUI-1
C2707520
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Consent for PGx Research (DNA)
Description

Consent for PGx Research (DNA)

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0031325
UMLS CUI-3
C0035168
Has informed consent been obtained for PGx research?
Description

Has informed consent been obtained for PGx research?

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0035168
If Yes, record the date informed consent obtained for PGx research
Description

If Yes, record the date informed consent obtained for PGx research

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Day Month Year
Blood sample collection (DNA)
Description

Blood sample collection (DNA)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0012854
Has a blood sample been collected for PGx research?
Description

Has a blood sample been collected for PGx research?

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0031325
UMLS CUI [1,3]
C0035168
If Yes, record the date sample taken
Description

If Yes, record the date sample taken

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
Day Month Year
Withdrawal of consent for PGx (DNA)
Description

Withdrawal of consent for PGx (DNA)

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0021430
Has subject withdrawn consent for PGx research?
Description

Has subject withdrawn consent for PGx research?

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0021430
If Yes, record the date informed consent withdrawn for PGx research
Description

If Yes, record the date informed consent withdrawn for PGx research

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0021430
Day Month Year
Blood sample destruction
Description

Blood sample destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
Has a request been made for blood sample destruction?
Description

Has a request been made for blood sample destruction?

Data type

text

Alias
UMLS CUI [1,1]
C0686900
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If Yes, choose one reason:
Description

If Yes, choose one reason:

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If other, specify:
Description

If other, specify:

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
Back to the top of the page

Similar models

Pharmacogenetic (PGx) Research Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject information
C2707520 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Consent for PGx Research (DNA)
C0021430 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
C0035168 (UMLS CUI-3)
Item
Has informed consent been obtained for PGx research?
text
C0021430 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Has informed consent been obtained for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
If Yes, record the date informed consent obtained for PGx research
Item
If Yes, record the date informed consent obtained for PGx research
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
Blood sample collection (DNA)
C0200345 (UMLS CUI-1)
C0012854 (UMLS CUI-2)
Item
Has a blood sample been collected for PGx research?
text
C0200345 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Has a blood sample been collected for PGx research?
Code List
Has a blood sample been collected for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
If Yes, record the date sample taken
Item
If Yes, record the date sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
Withdrawal of consent for PGx (DNA)
C2349954 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx research?
text
C2349954 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Has subject withdrawn consent for PGx research?
Code List
Has subject withdrawn consent for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
If Yes, record the date informed consent withdrawn for PGx research
Item
If Yes, record the date informed consent withdrawn for PGx research
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Item Group
Blood sample destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Has a request been made for blood sample destruction?
text
C0686900 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Has a request been made for blood sample destruction?
Code List
Has a request been made for blood sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, choose one reason:
text
C0392360 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
If Yes, choose one reason:
Code List
If Yes, choose one reason:
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other (Z)
If other, specify:
Item
If other, specify:
text
C2348235 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
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