ID

26101

Descrição

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Updated informed consent

Palavras-chave

Versões (3)
  1. 2017-10-09 2017-10-09 -
  2. 2017-10-23 2017-10-23 -
  3. 2018-01-11 2018-01-11 -
Titular dos direitos

GlaxoSmithKline

Transferido a

9 oktober 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

Inglês

Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários  
Updated informed consent
Descrição

Updated informed consent

1. Subject study status at the time of review of updated Informed Consent
Descrição

(*if not able to contact please complete section below)

Tipo de dados

integer

If subject currently on IP: Date updated safety text reviewed with subject
Descrição

Reminder: the deadline for updating subjects currently on IP is 3 months after the date of ethics approval

Tipo de dados

date

If subject currently on IP: Has the subject confirmed they are continuing on IP?
Descrição

If subject decides to permanently discontinue IP after review of the updated Informed Consent, complete the EOT/EW IP visit. For the IP Discontinuation reason, record the details in the 'Decision by subject or proxy' text box.l

Tipo de dados

boolean

If subject currently on IP: Did the subject sign the updated Informed Consent form?
Descrição

If subject withdraws consent to participate in study after review of the updated Informed Consent, complete the EOS visit. For the Study Conclusion form Primary reason for withdrawal, record the details in the 'Withdrew Consent' text box. If pending [3]: Reminder - please update the eCRF to enter either "yes" or "no" after the subject attends their next clinic visit

Tipo de dados

text

If subject signed the updated Informed Consent form: date subject signed the updated Informed Consent form
Descrição

date subject signed the updated Informed Consent form

Tipo de dados

date

If Subject who previously permanently stopped IP but remains in post-IP follow-up: Date subject informed of findings
Descrição

Date subject informed of findings

Tipo de dados

date

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Similar models

Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Updated informed consent
Item
1. Subject study status at the time of review of updated Informed Consent
integer
Subject study status
Code List
1. Subject study status at the time of review of updated Informed Consent
CL Item
Subject currently on IP (23)
CL Item
Not applicable - subject no longer ongoing in study at time of reconsent (study withdrawal, lost to follow-up, died, *unable to contact subject in third party follow-up) (25)
CL Item
Subject who previously permanently stopped IP but remains in post-IP follow-up (including third party follow-up*) (24)
Date updated safety text reviewed with subject
Item
If subject currently on IP: Date updated safety text reviewed with subject
date
continuation IP confirmation
Item
If subject currently on IP: Has the subject confirmed they are continuing on IP?
boolean
Item
If subject currently on IP: Did the subject sign the updated Informed Consent form?
text
updated Informed Consent form signature
Code List
If subject currently on IP: Did the subject sign the updated Informed Consent form?
CL Item
Pending - waiting for subject to visit the clinic to sign the form (3)
CL Item
Yes, date subject signed the updated Informed Consent form (Y)
CL Item
No - subject confirmed that they will not sign. Subject must be withdrawn from IP if refuses to sign. Complete the EOT/EW IP visit. (N)
date subject signed the updated Informed Consent form
Item
If subject signed the updated Informed Consent form: date subject signed the updated Informed Consent form
date
Date subject informed of findings
Item
If Subject who previously permanently stopped IP but remains in post-IP follow-up: Date subject informed of findings
date
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