Best Practices to Drive Time and Cost Savings for Contraceptives | Page 10

For these reasons, it becomes important to spend time upfront

Figure 8.

Using a Risk-Based Monitoring Approach

developing an ideal patient profile. This may take more time for
enrollment, but can save time at the end of the trial and ensure
the quality of data. This is a step in the process where the
expertise of a contract research organization (CRO), such as
Clinipace, can be leveraged to identify the desired participant
characteristics and develop a plan for adequate and
timely recruitment.

Risk based approach to monitoring (RBM) »
As in all clinical trials, monitoring throughout the trial lifecycle
is important in trials of contraceptive drugs and devices. A risk-based

REQUIREMENTS:
• Assurance of quality data and
minimization of participant risk
• Participants need to provide data
in a timely and accurate manner

• Central timely monitoring

BENEFITS:
• Early identification of 
non-compliant participants
• Deviations from protocol proactively
identified & addressed

• High-risk sites are identified, 
allowing for targeted site visits

approach to monitoring (RBM) applies a systematic process to the
trial lifecycle components (designing, conducting, evaluating, and
reporting the trial) that helps prevent or mitigate important and
likely risks to data quality and participants. In this way, RBM
places a focus on quality metrics, including enrollment and
data completeness, among others.
In relation to data quality, these risks include enrollment of a
In recognition of the benefits that RBM confers to clinical trials,

representative sample of women that also adheres to any regulatory

the FDA,16 European Medicines Agency (EMA),17 and Medicines and

requirements and ensures that the drug or device will be tested

Healthcare Products Regulatory Agency (MHRA)18 have produced

appropriately. This involves appropriate use or compliance to the

guidance documents that outline the expected use of RBM paradigms,

protocol and an appropriate number of “risk” events in the form of sex

including appropriate planning practices and documentation of the

acts. During the trial, participants need to provide data in a timely and

monitoring plan prior to trial commencement. These agencies also

accurate manner, one that avoids the risk of recall bias. Participants that

recognize that a number of approaches may be suitable for monitoring,

are not complying with the protocol or are not appropriately reporting

and, therefore, provide recommendations rather than requirements

need to be identified early so that they can be withdrawn, if needed,

for the use of RBM. Of utmost importance is the assurance of

and replaced with other participants. Early identification of these

quality data and minimization of participant risk.

participants prevents unnecessary delays to the trial.

clinipace.com

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