ID

33968

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information concerning the blood sample taken for pharmacogenetic research, it should be filled out at a time point post dose. It should be filled out at each treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Stichworte

Versionen (3)
  1. 18.12.18 18.12.18 -
  2. 18.12.18 18.12.18 -
  3. 09.01.19 09.01.19 -
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GlaxoSmithKline

Hochgeladen am

9. Januar 2019

DOI

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Blood Sample for Pharmacogenetic Research

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Study Visit
Beschreibung

Study Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Pharmagogenetic Research
Beschreibung

Pharmagogenetic Research

Alias
UMLS CUI-1
C2347500
Has informed consent been obtained for Pharmacogenetic research?
Beschreibung

If Yes, record the date informed consent obtained

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
Date consent obtained for Pharmacogenetic research:
Beschreibung

Informed Consent Date Pharmacogenetic Tests

Datentyp

date

Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C2347500
Reason for not obtaining informed consent
Beschreibung

If No, one reason:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347500
UMLS CUI [1,4]
C1882120
Specify the reason for not obtaining informed consent for pharmacogenetic tests
Beschreibung

If No, one reason:

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2347500
UMLS CUI [1,4]
C1882120
Physician's Initials
Beschreibung

Physician's Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0031831
Sample Collection
Beschreibung

Sample Collection

Alias
UMLS CUI-1
C0005834
Has a sample been collected for Pharmacogenetic research?
Beschreibung

Sample Collected for Pharmacogenetic Tests

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C2347500
If Yes, record the date informed sample taken
Beschreibung

Sample Collection Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Clinical Staff Initials
Beschreibung

Clinical Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Withdrawal of Consent
Beschreibung

Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
Has subject withdrawn consent for Pharmacogenetic research?
Beschreibung

Informed Consent for Pharmacogenetic Research Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
Sample Destruction
Beschreibung

Sample Destruction

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

Sample Destruction Request

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If yes, tick one reason
Beschreibung

Reason for Sample Destruction Request

Datentyp

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
Specify the other reason for sample destruction request
Beschreibung

Other Reason for Sample Destruction Request

Datentyp

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
Clinical Staff Initials
Beschreibung

Clinical Staff Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
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Ähnliche Modelle

Blood Sample for Pharmacogenetic Research

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1])
Study Visit
Code List
Study Visit
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
CL Item
Treatment Period 3 (Treatment Period 3)
Item Group
Pharmagogenetic Research
C2347500 (UMLS CUI-1)
Informed Consent Pharmacogenetic Test
Item
Has informed consent been obtained for Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Informed Consent Date Pharmacogenetic Tests
Item
Date consent obtained for Pharmacogenetic research:
date
C2985782 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Item
Reason for not obtaining informed consent
integer
C0392360 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C1882120 (UMLS CUI [1,4])
Reason for not Obatining Informed Consent
Code List
Reason for not obtaining informed consent
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Other Reason for not Obatining Informed Consent for Pharmacogenetic Tests
Item
Specify the reason for not obtaining informed consent for pharmacogenetic tests
text
C0392360 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C1882120 (UMLS CUI [1,4])
Physician's Initials
Item
Physician's Initials
text
C2986440 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item Group
Sample Collection
C0005834 (UMLS CUI-1)
Sample Collected for Pharmacogenetic Tests
Item
Has a sample been collected for Pharmacogenetic research?
boolean
C0200345 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Sample Collection Date
Item
If Yes, record the date informed sample taken
date
C1302413 (UMLS CUI [1])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Item Group
Withdrawal of Consent
C1707492 (UMLS CUI-1)
Informed Consent for Pharmacogenetic Research Withdrawal
Item
Has subject withdrawn consent for Pharmacogenetic research?
boolean
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Item Group
Sample Destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Sample Destruction Request
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 yes, tick one reason
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Reason for Sample Destruction Request
Code List
If yes, tick one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Other Reason for Sample Destruction Request
Item
Specify the other reason for sample destruction request
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])
Clinical Staff Initials
Item
Clinical Staff Initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
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