Risk-Based Study Training - Three Key Considerations

By Amanda Steenbergen, Sr. Director – Global Clinical Training

When you think about taking a risk-based approach to clinical trial training, what does that mean? A risk-based approach ensures the quality of a clinical trial by identifying, assessing, monitoring, and mitigating risks that could affect the quality or safety of a study. We use training to mitigate identifiable risks and decrease protocol deviations.

And there are plenty of risks to consider. Whether it's an investigator-initiated trial, a first-in-human PK study, a global phase three device, or a post-market registry study, you need to anticipate the risks of patient safety and data integrity as you develop protocols. Plus, different elements about the study determine the level of the potential risk. For example, the complexity of the study design and study population, the type of endpoints and the number of them, the types of patients you need to enroll, the site’s experience with clinical studies and the geographic locations of sites—all of these factors influence potential risks for the study.

Using what you know about potential risks and sharing that information with your sites is the foundation of a solid risk-based approach. That’s why training is such an important tool to help you anticipate and circumvent the risks.

Here are three things to know to help you develop and deliver training that will help you mitigate study risks with an effective risk-based approach.

To learn more about WCG, visit their Clinical Leader page.