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ID

28415

Beschrijving

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

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Versies (3)
  1. 09-10-17 09-10-17 -
  2. 23-10-17 23-10-17 -
  3. 11-01-18 11-01-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 januari 2018

DOI

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

    Engels

    Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

    1 Formulieren  
    Updated informed consent
    Beschrijving

    Updated informed consent

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

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

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    If subject currently on IP: Date updated safety text reviewed with subject
    Beschrijving

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

    Datatype

    date

    Alias
    UMLS CUI [1]
    C3174387 (Date of review)
    LOINC
    LP116867-5
    If subject currently on IP: Has the subject confirmed they are continuing on IP?
    Beschrijving

    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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    If subject currently on IP: Did the subject sign the updated Informed Consent form?
    Beschrijving

    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

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    If subject signed the updated Informed Consent form: date subject signed the updated Informed Consent form
    Beschrijving

    date subject signed the updated Informed Consent form

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0009797 (Consent Forms)
    If Subject who previously permanently stopped IP but remains in post-IP follow-up: Date subject informed of findings
    Beschrijving

    Date subject informed of findings

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0009797 (Consent Forms)
    Terug naar het begin van de pagina

    Similar models

    Updated informed consent GSK study Chronic Coronary Heart Disease NCT00799903

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Updated informed consent
    Item
    1. Subject study status at the time of review of updated Informed Consent
    integer
    C2348568 (UMLS CUI [1])
    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
    C3174387 (UMLS CUI [1])
    continuation IP confirmation
    Item
    If subject currently on IP: Has the subject confirmed they are continuing on IP?
    boolean
    C0805733 (UMLS CUI [1])
    Item
    If subject currently on IP: Did the subject sign the updated Informed Consent form?
    text
    C0021430 (UMLS CUI [1])
    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)
    C0021430 (UMLS CUI-1)
    C1611271 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Yes, date subject signed the updated Informed Consent form (Y)
    C0021430 (UMLS CUI-1)
    (Comment:en)
    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)
    C0021430 (UMLS CUI-1)
    (Comment:en)
    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
    C0011008 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    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
    C0011008 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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