1. The
FDA
Guidance
of
Risk-­‐Based
Approach
to
Monitoring
as
Viewed
From
CDM
Presented
By
William
Gluck,
PhD
VP,
DATATRAK
Clinical
and
ConsulEng
Services
DATATRAK
InternaEonal,
Inc.

2. Agenda
InteracEons:
Sponsors,
Clinical
OperaEons
and
CDM
Risk-­‐Based
Monitoring
– Challenges
for
Sponsors
– Challenges
for
Monitors
– Challenges
for
CDM
ImplementaEon
–
Will
there
be
any
affect
on
data
quality
or
integrity?
Will
the
Risked-­‐Based
Approach
require
roles/skill
set
adjustments?

3. TradiEonal
Paper-­‐Based
Work-­‐Flow
Pa#ent
Data
Database

4. Data
Flow
&
Monitoring:
The
Future
Centralized
CRA
CRC Database
CDM

5. SupporEng
Risked-­‐Based
Monitoring
–
Challenges
for
Sponsors
• “The
most
important
tool
for
ensuring
human
subject
protecEon
and
high-­‐quality
data
is
a
well-­‐
designed
and
arEculated
protocol.”
• Guidance
intends
to
assist
sponsors
in
developing
risk-­‐based
monitoring
strategies
and
plans
– Tailored
to
the
specific
human
subject
protecEon
and
data
integrity
risks
of
the
trial
– Focuses
on
criEcal
study
parameters
– Encourages
use
of
a
combinaEon
of
monitoring
acEviEes
– Encourages
greater
reliance
on
centralized
monitoring
pracEces,
where
appropriate
–
it
is
OK
not
to
do
100%
SDV

6. SupporEng
Risked-­‐Based
Monitoring
–
Challenges
in
Clinical
OperaEons
• Trial
specific
• Describe
monitoring
methods,
responsibiliEes,
and
requirements
• Components
to
consider
– DescripEon
of
monitoring
approaches
(e.g.,
Eming,
intensity,
acEviEes,
documentaEon)
–
Targeted
SDV
– CommunicaEon
of
monitoring
results
– Management
of
noncompliance
– Training
and
study-­‐specific
informaEon
– Monitoring
plan
amendments

7. SupporEng
Risked-­‐Based
Monitoring
–
Challenges
in
CDM
• Centralized
Monitoring
• Quality
and
Integrity
Checks
– Increased
checks
– Increased
data
collecEon
• Technologically
Few
Challenges
• Process/Workflow
Flow
–
KEY!

8. Data
Quality/Integrity
• IdenEfy
criEcal
study
data
and
processes,
e.g.
– Endpoints
– Serious
Adverse
Events
– RandomizaEon/
Blinding
– Consent
– Eligibility
Criteria
– Risks
specific
to
protocol
design
and
conduct
• Perform
and
document
a
risk
assessment
to
idenEfy
risks
to
these
criEcal
data
and
processes
• Design
plans
tailored
to
address
important
and
likely
risks
idenEfied
during
risk
assessment

9. Role
or
Skill
Set
Adjustments
Needed
to
Support
Risked-­‐Based
Monitoring
• Sponsors
• Site
Coordinators/Staff
• CRAs/Monitors
– Increases
in
support
and
technology
skills
• CDM
– Increases
in
technology
process
– Increases
in
training
skills

10. Summary
• From
the
perspecEve
of
CDM
– Need
coordinaEon
in
planning
across
funcEonal
groups/departments
– No
overwhelming
hurdles
to
implementaEon
• Guidance
reflects
acknowledgment
that
changes
to
the
clinical
trial
enterprise
are
OK
• Process
integraEon
is
key
to
efficient
use
of
resources
and
to
add
quality

11.
William
Gluck,
Ph.D.
VP,
DATATRAK
Clinical
and
ConsulEng
Services
Datatrak
InternaEonal,
Inc.
Phone:
919-­‐651-­‐0222
Cell:
919-­‐522-­‐9681
E-­‐Mail:
Bill.Gluck@datatrak.net