What makes some clinical sites easier to work with than others? In a previous blog, we shared tips for clinical study site selection, but selecting the sites is only the beginning. For the long haul of the study, the answer has something to do with TEAM. In this month’s blog, Bright clinical research associates Liz Reedy and Erica Kerstetter discuss four characteristics their favorite sites have in common and how those characteristics contribute to a strong working relationship and a more efficient and enjoyable clinical study process.
Timely data entry
Procrastinators need not apply at our favorite sites. Timely data entry (within a day or two of each subject visit) allows monitors and data managers to perform their focused reviews at a comfortable pace. The team can address problems and advise on potential issues before they become widespread and threaten subject safety or data integrity. Prompt identification and correction of protocol deviations or image upload challenges makes study execution smoother and monitoring visits a breeze. Timely data entry is also vital to ensure certain adverse events are reviewed by the study safety committee and, when required, promptly reported to regulatory authorities or Institutional Review Boards (IRBs).
Enthusiastic communicators
Not only is it more fun to work with engaged sites who are genuinely excited to be a part of the study, but it creates more efficient studies, too. Not surprisingly, we’ve observed a correlation between attentiveness during training/monitoring visits and better protocol adherence, which leads to reduced data queries and protocol deviations. We’re also able to schedule monitoring visits and investigator meetings much more efficiently when sites are responsive to emails and phone calls, saving time for all parties involved. Finally, when sites openly share requests and feedback from IRBs, this helps us promptly prepare the proper submission documentation, which leads to faster approvals and renewals. Overall, good communication between investigators, research coordinators, the CRO, and the study sponsor makes everybody’s job easier and allows the study to progress smoothly.
Speaking of making jobs easier, when we make in-person monitoring visits, it is so nice to have a well-prepared and welcoming coordinator to help us do our job in an unfamiliar setting, a new city, or after travel difficulties. Friendly interaction makes for a much more positive monitoring experience, and we sure appreciate the kindness.
Accurate documentation management
It is crucial for the site to maintain complete records and to keep essential regulatory documents up to date. Like timely data entry, having an organized system that is maintained at regular intervals can accelerate site activation, streamline IRB submission, approval, and renewal, and reduce the number of post-monitoring visit action items. The site’s attention to accuracy is especially important for the close-out visit, where we need to ensure all final requirements have been buttoned up. Also, FDA may come knocking at this stage of the study, and the likelihood of a successful audit increases greatly when the documentation is in order.
Methodical partners
Our top-performing clinical partners methodically follow good clinical practices (GCPs). These sites complete training in a thorough but timely manner, screen, and consent subjects with careful attention to eligibility criteria, submit comprehensive periodic reports on time, and conduct the study according to the protocol and applicable regulatory requirements. When deviations or queries occur, they work through actions items thoughtfully and promptly, and, when necessary, implement corrective or preventive actions to reduce the likelihood of recurrence. What a joy it is to work with research coordinators and investigators who understand the complexity of a clinical trial and who are committed to the necessity of a methodical process.
Conclusion
In our role as Bright clinical research associates, we conscientiously strive to build durable relationships between sites, monitors, and study sponsors. These efforts are more efficient, effective, and enjoyable when we are fortunate to TEAM up with sites who are timely, enthusiastic, accurate, and methodical. Thank you, clinical site partners, for the significant contributions you make to clinical research. We love working with you – go TEAM!
