ID

28415

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

January 11, 2018

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

Alias
UMLS CUI [1]
C2348568
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

Alias
UMLS CUI [1]
C3174387
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

Alias
UMLS CUI [1]
C0805733
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

Alias
UMLS CUI [1]
C0021430
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

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
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

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
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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
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])
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