0 Ratings
ID

26101

Description

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

Keywords

Versions (3)
  1. 10/9/17 10/9/17 -
  2. 10/23/17 10/23/17 -
  3. 1/11/18 1/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 9, 2017

DOI

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License

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

    English

    Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

    1 forms  
    Updated informed consent
    Description

    Updated informed consent

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

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

    Data type

    integer

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

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

    Data type

    date

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

    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

    Data type

    boolean

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

    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

    Data type

    text

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

    date subject signed the updated Informed Consent form

    Data type

    date

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

    Date subject informed of findings

    Data type

    date

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    Similar models

    Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

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