ID

38346

Descrição

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Pharmacogenetic research consent and withdrawal of consent form.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Palavras-chave

Versões (2)
  1. 05/10/2019 05/10/2019 -
  2. 11/10/2019 11/10/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

11 de outubro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

Inglês

Pharmacogenetic research consent and withdrawal of consent

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
PGx - Pharmacogenetic research consent
Descrição

PGx - Pharmacogenetic research consent

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

If you tick Yes, please fill in the Date informed consent obtained for PGx-Pharmacogenetic research and if a blood sample has been collected in the following items. If you tick No, please check the reason in the item "No informed consent obtained for PGx, reason".

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for PGx-Pharmacogenetic research
Descrição

day month year

Tipo de dados

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?
Descrição

If you tick Yes, please record the date sample taken in the following item.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
No informed consent obtained for PGx, reason
Descrição

No informed consent obtained for PGx, reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
If other reason for no informed consent obtained, please specify
Descrição

Other reason for no informed consent obtained

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
UMLS CUI [1,5]
C1882120
Date of sample taken of PGx
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C2347500
Pharmacogenetic research withdrawal of consent
Descrição

Pharmacogenetic research withdrawal of consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C2347500
Has subject withdrawn consent for PGx research?
Descrição

If you tick Yes, please note the date of informed consent withdrawn in the following item.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
Date of informed consent withdrawn
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Descrição

If you tick Yes, please check reason in the following item.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
Reason for request for sample destruction
Descrição

Reason for request for sample destruction

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
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Similar models

Pharmacogenetic research consent and withdrawal of consent

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
PGx - Pharmacogenetic research consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Informed consent for PGx
Code List
Has informed consent been obtained for PGx-Pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Date informed consent obtained for PGx-Pharmacogenetic research
Item
Date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
text
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Blood sample for PGx
Code List
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
CL Item
Yes (Y)
CL Item
No (N)
Item
No informed consent obtained for PGx, reason
text
C0566251 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
No informed consent obtained for PGx, reason
Code List
No informed consent obtained for PGx, reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (Z)
Other reason for no informed consent obtained
Item
If other reason for no informed consent obtained, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C1882120 (UMLS CUI [1,5])
Date of sample taken of PGx
Item
Date of sample taken of PGx
date
C1302413 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Item Group
Pharmacogenetic research withdrawal of consent
C1707492 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Withdrawn consent for PGx
Code List
Has subject withdrawn consent for PGx research?
CL Item
No (N)
CL Item
Yes (Y)
Date of informed consent withdrawn
Item
Date of informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a request been made for sample destruction?
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Request for sample destruction
Code List
Has a request been made for sample destruction?
CL Item
No (N)
CL Item
Yes (Y)
Item
Reason for request for sample destruction
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
Reason for request for sample destruction
Code List
Reason for request for sample destruction
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
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