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The
Walter
B.
Morley
Research
Foundation,
Inc.
8343 Roswell Road
Suite 322
Atlanta,
GA 30350
P:
(404) 625-0036
F:
(404) 745-8400
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Responsible
Conduct
for
Research:
Clinical
Investigator
Training
Program
Highlights
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Drug
and
Device
Development
Opportunities |
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Responsible
Conduct
for
Research:
Roles,
Responsibilities,
and
Strategies
for
Success |
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Indemnification:
Contract
Language
Risks |
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The
Right
to
Know:
Informed
Consent
and
HIPAA
Regulations |
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Protection
of
Human
Subjects:
IRBs
and
Their
Impact
on
Research |
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Vital
Information
for
Research
Sites:
Surviving
IRB,
FDA,
and
Sponsor
Audits |
Target
Audience
This
course
is
intended
for
clinical
investigators,
study
coordinators,
and
industry
personnel
involved
in
phase
I-IV
clinical
research.
The
course
is
invaluable
to
any
clinical
investigator,
whether
a
seasoned
veteran
or
a
neophyte.
It
is
strongly
recommended
that
both
the
investigator
and
the
study
coordinator
from
a
site
attend
the
training
program.
Learning
Objectives
Upon
completion
of
this
course,
participants
will
be
better
able
to:
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Explain
the
drug
development
process
in
both
clinical
and
financial
terms |
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Differentiate
between
phase
I,
II,
III,
and
IV
clinical
studies |
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Define
the
key
elements
for
successful
trial
execution |
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Apply
clinical
ethics
and
ethical
decision
making
to
studies |
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Describe
the
FDA
regulations
and
ICH
guidelines
governing
informed
consent,
IRBs,
and
financial
disclosure |
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Define
the
FDA
inspection
process
and
benchmarks
mandated
for
clinical
trials |
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Interpret
FDA
and
HIPAA
regulations |
Certificate of Completion
A certificate will be
issues upon successful completion of the course.
Cost:
$599.00/Person
Hours:
1-Day
Course,
8:00
am
–
5:00
pm
Back
to
Training
Programs
Go
to
Schedule
&
Registration
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