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1. DSMB
update
The latest TRACK DSMB meeting was held
Wednesday, 7th June. After review of the trial data the DSMB
recommended that the trial continues unchanged. We look
forward to sharing all the results from the DSMB at the
round of upcoming Investigator Meetings to be conducted in all
regions through July. Please keep an eye out for an
invitation as we would encourage all site staff to attend
wherever possible.
2. Data Entry
Data
quality assurance is a key aspect to the integrity and success of
the TRACK trial. To ensure we are capturing accurate details
within the database, we wish to provide some friendly reminders
on correct procedures for data entry.
STUDY MEDICATION LOG - Stopped IMP
If a
participant has stopped IMP, please update the study medication
log and ensure to check whether the reason for stopping is
listed under �reasons for stopping� before selecting
�other�.
STUDY MEDICATION LOG - Start/ Stop Dates
Please
ensure that once a participant has been randomised that the study
medication log is updated with the date that the participant
started their study medication. Then remember that throughout the
study all study medication start and stop dates must be entered
into the study medication log.
CLINIC VISIT - Study Medication
If 'NO' is
ticked for �Remaining tablets re-dispensed
to participant� please ensure to provide the reason
and not the number of tablets not re-dispensed.
CONCOMITANT MEDICATIONS
A reminder
that when completing the concomitant medication page
to please only select �other� if the medication name or
category is not in the list provided.
Database Queries
You may have noticed some queries being
raised for your site. Our data management team is currently
performing data cleaning for the TRACK trial and with this,
we would appreciate if sites can review and respond to open
queries within 2 weeks of being raised. If you have any
questions regarding this, please do not hesitate to contact the
TGI project team for assistance.
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