Advantages And Disadvantages Of Risk Based Monitoring

Risk Based Monitoring (RBM) is becoming more popular and widely used in clinical trials in the past few years. The concept of the risk based monitoring is to transform the traditional 100 % source data verification (SDV) monitoring approach towards a new concept of monitoring that includes varies of centralised activities in critical data evaluation and process monitoring. RBM is a monitoring approach which combines risk assessment and risk management by utilising key data indicators, along with analytical tools to identify risk at study level, site level and subject level respectively. It also introduces the new term Source Data Review (SDR) to the industry. Source Data Verification which is known as SDV is defined as “the process by which

However, RBM not only impacts the monitors but also influences regulators, sponsors, CROs, clinical research sites and cooperative organisations. The benefits of the RBM are outlined below and categorised in the following sectors.

 Regulators: (including the FDA, MHRA and EMA)

 Accelerate changes in regulatory

In the past few years, many guidance such as Guidance for Industry: Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring and ICH E6 (R2) Integrated Addendum to Guideline for Good Clinical Practice around the RBM topic have been published by the regulators. These articles set up the RBM frame and provided constructive information to the sponsors, monitors, CROs and even vendors and helped the industry to shift the 100% on site SDV to RBM.

 Define critical study data and processes

Push the industry to focus on key study parameter and risks and ensure the patient safety is well protected.

 Avoid clinical disaster

Regulators are dedicating themselves to setup early warning and action plan to mitigate and prevent risks. The unanticipated risks have become more easier to be picked up and mitigated by utilising

 Create business flexibility

The flexibility to adjust monitoring levels during a study if risks change, giving us the ability to adapt SDV review and frequency of onsite monitoring visits by supplementing oversight with centralised monitoring methods and remote monitoring visits. This activity is constantly changing during the trial and drives the business to flow.

 Monitors:

 Increase onsite working efficiency:

During the on site visit, monitors can focus on addressing critical issues that cannot be resolved remotely. The centralised remote monitoring also save a lot of travel time and energy for the monitors, monitors can use bill their hours more efficiently to the projects since monitors no longer suffer from travel tiredness between visits.

 Visualise risk:

Monitors can utilise the RBM tools to prepare the monitoring visit. The risk is transformed into simple colours according to its risk level and it can be easily caught by the monitors in the risk matrix and investigate further.

 Clinical Research Sites:

 Save time and