Risk-based monitoring (RBM) is an adaptive approach that focuses monitoring activities on areas most likely to impact patient safety and data quality, rather than uniform monitoring of all sites. It uses a risk assessment to determine each trial's customized monitoring plan. Key steps in RBM include defining risks, selecting key risk indicators and thresholds, determining action recommendations, and continuously reviewing and adjusting the plan. RBM relies on technology and qualitative and quantitative data to evaluate metrics like timelines, efficiencies, and quality.

1. WHAT IS
Risk-Based Monitoring?
It’s NOT just about reducing monitoring
visits. It’s about using a solid process and
the right people & technology TO RUN A
BETTER TRIAL.
RBM
101TRADITIONAL APPROACH:
On-Site Monitoring
Monitoring 100% of the data on site at a regular
interval (every 4-8 weeks) regardless of how
experienced the site was, regardless of their
performance, with little focus put on assessing
the quality of critical procedures or processes
in the study.
DIFFERENT TYPES
OF MONITORING
Central Monitoring
Performed remotely for the purpose of viewing aggregated,
study-level data to identify trends or outliers
Off-Site Monitoring
Assesses potential site issues around timeliness of data entry
and overall site performance
On-Site Monitoring
Used to assess investigator involvement and GCP compliance
CHALLENGES TO
SUCCESSFUL RBM
Customized approach to each individual trial
based on a risk assessment that identifies
potential issues.
RBM is NOT FIXED. It is ADAPTIVE and meant to focus activities
to the areas most likely to impact patient safety and data quality.
DETERMINE KEY RISK INDICATOR THRESHOLDS
WITH THE PLAN IN
PLACE, EVALUATE
YOUR RBM PROCESS
ADJUST
THE
PLAN
Warning range: Can significantly impact study results
(sample indicators: safety data, not following protocol
definitions, failure to report important adverse events)
Awareness range: Collect additional information
to see what is at risk
Lack of understanding
about the risks of the trial
Lack of buy-in from study team
Lack of buy-in from leadership
Lack of communication
We don't have the technology we need
Lack of a clear plan
Unclear roles and responsibilities
18%
14%
14%
36%
7%
7%
5%
Are issues
repeated?
Are
sites experiencing
the same issues?
Are monitors
surprised at
on-site visits?
Every company is different and will use a different set of people and different
models to monitor the trial. Common key players are from the study team,
site-facing roles and site staff. Two key factors: Technology is essential and
design should be flexible.
Acceptable range: Not damaging to trial results
or patient safety (sample indicators: age, height,
concomitant treatment or illness)
RISK-BASED APPROACH
TO MONITORING
KEY STEPS:
Define Risks
Look at this from the program, protocol and site
level.
KRI & PI Selection
Variables that need to be reviewed regularly
because they may indicate a problem and have
an underlying influence on the quality of a study.
Threshold Setting
Using technology, set different thresholds for
selected risk indicators. The system notifies you
when a threshold reaches a value that you don’t
find acceptable.
Action Recommendations
The risk thresholds range determines what
action is taken and many times determines the
timeliness of an action.
Define Your Plans
Determine who needs to be informed. Decide a
mechanism for communicating alerts, need for
action and changes to the monitoring plan.
Review & Adjust
Continuous review and assessment allows you
to determine if you need to adapt.
HIGH
LOW
MEDIUM
WHO PERFORMS RISK-BASED MONITORING?
HOW DO I EVALUATE MY
RBM PLAN?
QUALITY METRICS
- Number and classification of critical inspection findings per audited site
- Number of significant protocol deviations per site
- Number of unreported, confirmed SAEs as discovered through
any method
TIMELINES / CYCLE TIME METRICS
- Average number of days from data entry to initial monitoring
- Median number of days from visit to CRF data entry
- Median number of days from query open to close
- Median number of days from issue open to close
EFFICIENCY METRICS
- Average monitoring (all types) cost-per-site
- Average interval between on-site monitoring visits per site
What to assess...
$
#
DAYS
Quantitative Data: Key clinical trial data and operational metrics
Qualitative Data: Risk assessment, monitor feedback, site feedback
Quality by Design (QbD): Foundation to ensure data quality and patient
safety. QbD includes a focus during protocol and program development
on identifying key risks to subject safety, data quality and GCP/regulatory
compliance, providing a basis for implementation of RBM
Source Data Verification (SDV): Process by which data in the CRF is
compared to original source to confirm transcription
Source Data Review (SDR): Process of reviewing source documentation
to check quality, compliance, staff involvement and other areas NOT related to
CRF
Risk Assessment & Categorization Tool (RACT): Risk assessment
performed to identify and mitigate program, protocol and site risks
Key Risk Indicators (KRIs): Variables which are considered to have
underlying influence on the quality of a study or impact on a subject's safety
and are assessed by comparison across a program, study, country and/or site
Performance Indicators (PIs): A roll-up of the KRI data that allows for
short term trend analysis to enable seeing patterns of poor performance at
a site
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COMMON
INDUSTRY
RBM TERMS...
Time consuming High costs Data quality not
guaranteed
Develop quality management
& monitoring plans
Assess
risk level
Identify critical data
and processes