ID

38346

Description

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

Keywords

Versions (2)
  1. 10/5/19 10/5/19 -
  2. 10/11/19 10/11/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 11, 2019

DOI

To request one please log in.

License

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

English

Pharmacogenetic research consent and withdrawal of consent

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

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

PGx - Pharmacogenetic research consent

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

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".

Data type

text

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

day month year

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

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

Data type

text

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

No informed consent obtained for PGx, reason

Data type

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
Description

Other reason for no informed consent obtained

Data type

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
Description

day month year

Data type

date

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

Pharmacogenetic research withdrawal of consent

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Has subject withdrawn consent for PGx research?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

If you tick Yes, please note the date of informed consent withdrawn in the following item.

Data type

text

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Date of informed consent withdrawn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

day month year

Data type

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?
Description

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

Data type

text

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

Reason for request for sample destruction

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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