The Research Compliance Maze – Play It Safe

Last month, the Clinical Conductor Webinar Series discussed research compliance and the ways research organizations can navigate through the process. Kelly Willenberg, founder of Kelly Willenberg and Associates, started the webinar with a review of how clinical research sites handle research compliance comprehensively. Willenberg went over the number of risks that could potentially come up during the research process; the list could have been even more extensive due to the nature of the clinical trial process. Clinical research sites need to determine what risks could be the most problematic for their specific site, and then move forward with preparing for those risks in advance.

To maintain research compliance, Willenberg suggested three steps to prepare for any future issues; be resourceful, plan for an emergency, and prepare in advance for any regulatory compliance issues.  After your research site has prepared for potential risks, Willenberg went over some steps for success when it comes to tackling research compliance. One of the biggest factors a research site needs for success is teamwork. Often, people aren’t working together or looking for process/workflows that work for everyone involved during the clinical research process. When your office isn’t working together or with other organizations, this can become a major issue. In the absence of suitable IT systems, clinical research organizations need to deploy enough people to evaluate those processes and avoid duplicate work being done. In most organizations, there are a variety of stakeholders which can lead to situations where the stakeholders are misaligned. Willenberg wants research organizations to get all the stakeholders together and sit them down to establish research compliance goals. Once your research organization is prepared for any potential problems with your compliance, you will have better financial gains and granularity. Your research organization will also be more efficient in your project management processes, leading to overall cohesion amongst your stakeholders.

Once you have established your goals and created a plan for potential problems at your research organization, Willenberg suggests evaluating the current state of your research site. Look at your entire team and evaluate how they can work together as a team. Never have a task at your research site that only one person knows how to do; evaluate which members should be cross trained on tasks to prevent a situation where someone leaves the organization, and no one has any idea how to do one of those tasks. Understanding your personal and their duties allows directors at research to properly delineate roles and responsibilities amongst staff members. Willenberg reminded attendees that they need to keep clinical trial billing compliance and revenue cycle integrity on their radar.

By evaluating research site processes on an ongoing basis, along with proactively managing risks, research sites will be prepared for any surprises. The bottom line: understand the importance of an organizational culture and your readiness so you can play it safe.

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