The document introduces GSK's approach to implementing a risk-based monitoring (RBM) strategy using a new RBM tool. The tool analyzes data from multiple sources to generate risk indicators and overall risk scores for clinical trial sites. It then produces monitoring activity plans to guide monitors to focus on high-risk sites and activities. The tool aims to make monitoring more data-driven and risk-focused compared to traditional schedule-based approaches. A demo of the tool shows how it can detect changes in sites' risk scores over time and identify sites for further central review and discussion. Some initial challenges in implementation were confusion around the tool's purpose and indicators. Feedback indicated the tool helps prioritize monitoring efforts and drives more data-driven conversations

1. “Data-Driven”
Risk Based Monitoring
Neill Barron
Clinical Data Strategy
GSK

2. Objectives
• Introduce GSKs approach to implementing
an RBM strategy
• Overview/Demo of the RBM tool &
Processes to support this strategy
• Use of Tool on real data – Mini-Pilots
• Benefits & Challenges
2

3. Traditional Monitoring Methods vs. RBM “Data-Driven”
Model
TraditionalTraditional
• Monitoring visit based on predetermined
schedule, independent of workload
• All sites and events treated equally
• On-site CRA visits not predominantly
concentrated on high value activities
• Solely driven by CRAs with little involvement
from the DQL or central team
Risk Based MonitoringRisk Based Monitoring
• A “Data-Driven” approach
• Visits driven by:
– Quality
– Safety signals
– Workload
• CRA productivity focused on key areas
– Subject safety
– Data integrity
– Regulatory compliance
• New tools allow greater involvement of
central team in decision making

4. RBM Tool Concept – A “Data-Driven” approach to
monitoring
• Data from various source systems (Inform, Etrack, Ramos,
External data) are consolidated into a single data source
feeding the RBM tool
• 11 “Core” RBM Risk Indicators are created in the RBM tool
by analysing this data
• The overall risk profile of sites (“Overall Risk Score”) is
derived from the cumulative effect of risk from each of the
core risk indicators, and any study specific risk indicators
defined
• Consolidated site level reports (“Monitoring Activity
Plans”) are generated from the RBM tool and used by
monitor to guide monitoring intervention (what) and
monitoring frequency (when)
• Using “Oversight Visuals” in the RBM tool, study team
review “Overall Risk Score” by site to detect outlier sites
(not all sites) e.g. Highest Risk sites, that drive targeted
conversations with CSM/CRA
• CSMs will also access “Oversight Visuals” so they can get
helicopter view of their local sites.
The RBM tool enables a single consolidated “helicopter” view of risk across sites, with the
ability to drill into the detail behind any or all of the risk signals, in order to drive focussed
and targeted monitoring intervention, where and when needed
eDC CTMS
External
Data
Consolidated
RBM Database
Core RBM
Indicators x 11
Study Specific
Indicators (2-
4)
Monitoring
Activity Plan
Oversight
“Helicopter
view” Visuals
CRA Action
Central
Oversight
Study
Specific
Data

5. Scope of “Risks” covered in RBM tool
5

6. Tool Demo

7. RBM Process &
“Mini-Pilot” outputs
7

8. DM Refreshes RBM Tool
Reports
CRA pulls site-specific
Monitoring Activity Plan
CRA reviews MAP (in
conjunction with other
site information)
CRA carries out corrective
actions
DM reviews RBM
‘Oversight’ visuals
“outlier” sites
DM discusses “outliers”
with Central Team,
Country Study Managers
CRA determines
corrective actions
If required, DM or Country
Study Mgr discusses
potential root-causes and
remediation with CRA
RBM Process Overview
CRA documents all site
contacts
Central Team discuss
potential root-causes and
implement remediation
Data Changes
feed back to
RBM Tool
Study
level
issues
Site
level
issues
CRA = Clinical Research Associate (monitor)
DM = Data Manager
Study Team = DMs, Study Lead, Stats
DM creates the Monitoring
activity plan

9. Sample Site 1 - High Value site exhibiting High Risk
9
00 Month 0000Presentation title in
footer
Monitoring Activity
Plan
Adobe Acrobat
Document

10. Sample Site 2 - Site exhibiting improvement after
targeted RBM tool driven action
10
00 Month 0000Presentation title in
footer
Site exhibiting
Overall Risk Score
Reduction between 11th
Nov and 18th
Dec.
Adobe Acrobat
Document
Adobe Acrobat
Document

11. Sample Site 3 - Site exhibiting increase in Overall Risk Score
11
00 Month 0000Presentation title in
footer
Site exhibiting
Increase in
Overall Risk Score
Between October
and December

12. Sample Site 4 – Low Risk Site with High Frequency MVs
12
00 Month 0000Presentation title in
footer

13. Sample Site 5 – Higher Risk Site with Low Frequency MVs
13
00 Month 0000Presentation title in
footer

14. Challenges to Implementation
• CSMs/CRAs getting “defensive” re
risks identified and focus was on
actions to turn risk signals from
“Red” to “Green”
• Some confusion between general
risk indicators/instream data review
and RBM indicators
• Lack of clarity that RBM tool is not
a data-management tool to
manage daily operational DM tasks
14
February 2014RBM Mini-Pilots
Observations
• Training on each risk indicator, its
meaning and how mitigating actions
may or may not affect risk signal
• Clear guidance for EST on identifying
study specific indicators for RBM –
what does an RBM indicator look like?
• Clear messaging that the RBM tool is
an additional tool to drive monitoring
intervention - not a general DM/data
quality tool. Understanding where
RBM tool fits with other tools is key
and clear role definition – avoid
duplication of effort
Some impacts on Capability development

15. Feedback from end users on benefits
15
00 Month 0000Presentation title in
footer
“it is fascinating that the shift
that we have seen for some
of the sites in their overall risk
score now that the study
specifics are in there…risk
scoreds align and somewhat
quantify/verify the risks that
we were ‘feeling’”
“Encourages real
depth of discussion
about what types of
data are important
and value added for
the study”
“Provides the
capability to
customize and target
LOC or site/CRA
specific training,
actions to address
risks that are
identified in RBM.”
“Allows high level
oversight of relative
performance of sites
– this relativity is not
available by other
means to either
central study teams,
or LOCs or CRAs
“Provides real data
to discuss – versus
“feelings” about
potential problem
sites”
• New issues detected
earlier – e.g. Rounding at
sites, IP Compliance,
Frequent Rater Changes
• Provides “Real” data to
drive conversations between
Study Team and LOCs
around problem sites and
monitoring strategy
• Allows LOCs and CRAs to
develop and implement
targeted action for areas of
highest risk
• Provides a “one-stop shop”
complete data driven view of
risk across sites,
consolidating various data
sources

16. QUESTIONS
16