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BASIC
MONITORING COURSE
FOR MEDICAL DEVICE CLINICAL INVESTIGATIONS
Course
duration: 2½ days
Every sponsor, every monitor dreams of obtaining high
quality data the first time. Non-compliance issues
and unusable data are the major problems encountered
during data collection.
We all know that cleaning up data retrospectively
is time consuming, adds extra cost to trials, and
delays production of the final report.
This course enables medical device manufacturers to
get a greater value out of their clinical investment
by:
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Significantly
reducing the training time of new CRAs.
•
Providing
CRAs with practical tools in order to monitor efficiently.
The
CRAs who attend this course will be able to:
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Understand GCP and why it needs to be respected.
•
Understand
the outcome of non-compliance.
•
Work
fast and efficiently.
•
Monitor
independently.
•
Reduce
non-compliance issues.
•
Deal
with difficult investigators.
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Collect/produce
valid data from the clinical sites.
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Reduce
the number of queries.
Who
should attend:
New and junior clinical research associates in search
of monitoring excellence.
Day
1
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How
did Good Clinical Practice start and how did it evolve
(GCP)
•
Responsibilities
and Roles under GCP
•
Basics
of GCP when developing and managing a medical device
trial
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Set
up of a clinical investigation with medical devices
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Understanding
and implementing a clinical investigation plan
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Review
of other essential documents in a clinical investigation
Day
2
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Selecting
the right Investigation centers
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Different
ethics aspects to be taken into account
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Pre-study
visit activities
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Get
a good start: conduct effective initiation visit
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Role-plays:
solving problems at initiation visits
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Maintain
compliance: conducting periodic monitoring visits
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Getting
meaningful data: challenges of effective source document
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Verification
(SDV)
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Role-plays:
solving problems during monitoring visits
Day
3
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Relationships
with the study team when monitoring a clinical trial
•
Role-plays:
solving problems with site compliance
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Ensure
long-term documentation retention: close out visit
and follow-up
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Conclusion
and discussions
For information on booking D-TARGET training courses,
please contact
us.
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