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Study Overview
The TRACK trial will evaluate whether a small dose of
rivaroxaban, a blood-thinning medication, would reduce cardiovascular
death or major cardiovascular events in patients with advanced stages
of chronic kidney disease.
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Important Updates & Reminders
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1. DSMB Meeting Preparation
To ensure that all data within the TRACK database are as
clean as possible in time for the upcoming DSMB meeting, we ask
that all sites complete the following tasks by November 11th:
- Report events
- Complete data entry
- Respond to data queries
- Send the latest screening log to your Regional/Central Coordinating
Centre.
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2. Participant's personal & identifiable
information
When completing and checking your site's screening log
each month, please ensure that details such as the Medical Record Number,
participant name, and personal details are removed from the log prior to
sending the screening log to the lead sponsor/global study team.
If any personal
or identifiable data is sent, it will be reported as a data breach.
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3. Participant Information Video
The Global Project Team recently created a video to aid
sites in the participant recruitment process. The video is a summary of
the existing Participant Information Sheet & Consent Form (PISCF) and
aims to help patients gain a brief overview of the study and what their
participation entails. This video can be shown to any potential
participants as supplementary material to the PISCF.
Click here to access the video.
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4. TRACK Website
Please note that going forward, the TRACK Trial website can
only be used by health professionals. This is to meet the regulatory
requirements in some of our participating countries. Participant-directed
pages have been removed from the website.
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Recruitment and Country Updates
All figures are as of 25 Oct 2022.
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Name: Prof. Habib Skhiri
Position/Role: TRACK Tunisia National
lead
Location: Monastir, Tunisia
About: Professor Skhiri has a Paediatric Nephrology Diploma,
Immuno-Rheumatology Diploma, and Nephrology Certificate
at Universit� Paris 5 Ren� Descartes, France. He also completed
the HESPERIS transplantation training course in Helsinki and Munich
and obtained a certificate for therapeutic strategies in infectious
pathologies at Bichat-Claude Bernard University in Paris.
In Paris, Professor Skhiri
worked as an Associate Physician in nephrology at Bichat Hospital and also in nephrology and kidney transplantation at
Necker Hospital. He is currently Professor
of Nephrology at Fattouma Bourguiba
Hospital, Monastir, Tunisia. He has been head of
the nephrology department since 2019 and also the president of
Tunisian Society of Nephrology since December 2021.
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Name: Farah Zribi
Position/Role: Senior Clinical
Research Associate
Location: Tunisia
About: Farah has a multitude of
experiences across 8 years in Clinical Research within Tunisian CROs
and also in freelance where she monitored
different trials in different therapeutic areas such as Neurology,
Ophthalmology, Dermatology, and Cardiology.
Farah was also responsible for different departments and
various tasks such as data management, statistical analysis, quality
assurance, project management, and pharmacovigilance. She joined Eshmoun Clinical Research in March 2022.
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