This month’s blog by Liz Reedy and Kari Thomas is all about learnings gained from working as both research coordinators and clinical site monitors. Their experiences give our team a unique perspective on how the perfect pairing of research coordinator and study monitor can help make your clinical study a success.
The Perfect Pairing Takes Caring & Sharing
From early engagement in the site activation process to clear communication throughout study execution, there are many opportunities for site research coordinators (RCs) and study monitors to work together toward the common goal of a executing a successful clinical study. How do they do it? By building a relationship based on caring and sharing.
Caring
Respect Each Other’s Time
With multicenter studies running across the U.S., or even across the globe, and the potential for investigational interventions to happen outside of “regular working hours,” it’s important to be aware of time zones, schedules, and expectations around the timing for calls and monitoring visits.
In addition, monitors and RCs should agree in advance about training or monitoring visit logistics and agendas. This ensures the right people are available at the right time for the right topics. Agendas should also include a buffer at the end of the day to address any unexpected topics that arise.
Understand Each Other’s Processes
Typically, monitors are working with multiple sites, and RCs are running more than one study; this means lots of variability in protocols, people, and processes. Be sure that each party understands their roles and responsibilities for the specific processes required by the study protocol. Here are some points that require careful attention:
- Does the site consider certain assessments to be non-standard of care, and is their standard process at odds with the protocol? RCs and monitors should talk right away about these potential issues to lessen the chance of protocol deviations or missing data.
- Is the monitor asking about a contract that is stuck with legal? If so, the RC can offer to make an introduction to the responsible party to streamline communications.
- Does the site start-up process take a long time and/or is it overly complicated? RCs know their site best, but monitors may be able to leverage experience from other sites to help accelerate this critical time between site initiation and subject enrollment.
Communicate
Communication is essential for any relationship, and the relationships between RCs and monitors are no different. Here’s how we strive to make communication as easy as ABC and D:
- Ask questions – over email, on the phone, during training, and at monitoring visits. Despite good clinical practice and plenty of regulations, not all protocols are created equal. Don’t be shy about getting clarification if something seems confusing. The RC can pull on their deep knowledge of the therapy to answer questions, and the monitor might identify an opportunity to improve the protocol or case report forms (CRFs).
- Be prompt. We encourage our team to reply to messages from sites within one business day. If they don’t know the answer within that timeframe, they still respond to let the site know they received the request and are looking into it. Prompt clarification from sites is appreciated too. However, neither side should rush a reply. Promptly responding with incomplete or inaccurate information could, at worst, cause a problem with the study and, at best, annoy the recipient.
- Clearly respond to inquiries with thoughtful and concise answers. If a topic is getting too convoluted in writing, pick up the phone. For complicated topics, a verbal conversation is often more efficient than an email.
- Document essential correspondence in both the site and sponsor files. By “essential,” we mean substantive correspondence relating to key decisions that may be questioned by study leadership or FDA during the study, the submission review, or an inspection. Whenever you encounter essential correspondence, save copies of email messages and summarize phone calls or in-person discussions in memos to file.
Sharing
Provide Clear, Complete Source Documents
Despite all that caring, there is a common potential issue: Incomplete site source documents. If it isn’t documented, it didn’t happen, and that is especially true for clinical studies.
One role of the monitor is to ensure source data are entered completely and clearly. If there’s information of particular interest to the clinical study, but it’s not standard-of-care data, consider accepting data entry directly into the electronic data capture (EDC) system or suggesting that RCs complete a paper copy of the CRF to place in the subject file. In the case of a serious adverse event, RCs should be sure to provide the appropriate source documents for monitoring and safety committee review.
Share Knowledge
With the common goal of a complete dataset from a compliant study, RCs and monitors both benefit from sharing knowledge:
- Walking through the EMR or EDC together can accelerate the learning curve and provide time to bond over quirky or clunky technology.
- Sharing monitoring expectations and approaches can help an RC prepare for an upcoming visit. For example, the monitor could provide the following outline to an RC: “The plan is to look at these 5 subjects, starting with the EMR source and then filling in gaps with paper CRFs and subject file notes.”
- Does the RC have a special way of organizing the subject binders? Don’t make the monitor crack the code – instead, walk them through an example.
Introduce Useful Tools
Finally, share your tools:
- As a monitor, do you have a helpful template for tracking subject screen failures? Give a copy to your RC friend! It will help RCs keep better track of this information, and familiarity with the format will simplify monitoring.
- As an RC, has another sponsor provided a quick reference guide or laminated pocket cheat sheet for eligibility criteria? Ask your monitor pal if a similar tool could be generated for the study at hand.
Happily Ever After
Clinical studies are all about the people – the people receiving care, the people treating subjects, and the people executing the protocol to collect and monitor data. Whether your study involves a few subjects completing a brief visit or hundreds of subjects with years of follow-up, establishing a caring and sharing relationship between RCs and monitors is time well spent.
