Research Site Best Practices for Collaborating with CRAs on Clinical Trial Monitoring

If you work at a research site, chances are you have had to work in some capacity with site monitors — also known as clinical research associates (CRAs). Oftentimes, site monitors are contracted by the sponsor through a CRO, and their primary function is to support clinical trial monitoring activities as dictated by regulatory guidelines and sponsor-specific needs.

CRAs often serve as the primary intermediary between the sponsor and site, and as such they play a crucial role in the execution of a trial. But a strong collaborative relationship between sponsors and CRAs is crucial to running trials that are efficient and compliant.

Unfortunately, traditional monitoring practices can create bottlenecks and inefficiencies for sites and CRAs alike. On-site monitoring visits in particular can cause significant time and resource constraints for study stakeholders, who must dedicate staff effort and physical space in order to facilitate the monitors’ access to source data and other important study documents.

What’s more, site monitors are responsible for ensuring that clinical inventory is sufficient throughout the trial and that sites are abiding by approved study documents. Without real-time visibility to site activity, CRAs may be hindered in their ability to support their sites. Additionally, if sites are susceptible to queries due to lapses in inventory and sample management — or if they are otherwise unable to respond to queries in a timely manner — it can create a lot of back and forth between sites and CRAs, diverting precious resources away from other important study tasks.

So what can sites do to improve their collaborative relationship with their site monitors? This blog explores three strategies that sites can implement to dramatically improve their approach.

Enable centralized monitoring

Sites should take advantage of any opportunities to digitize and centralize their operations in order to streamline communication and data exchange between research sites and CRAs. By consolidating all relevant information — such as lab kit data and biospecimen data — into a centralized platform, both parties can access real-time updates and collaborate more efficiently. 

This approach minimizes the need for on-site visits, reducing time commitments for CRAs while ensuring that research sites remain compliant with protocol requirements. Centralized monitoring also enhances transparency and accountability, as all stakeholders have access to the same information. 

Pull inventory and sample reports for monitors

Providing site monitors with comprehensive inventory and sample reports empowers them to effectively assess site performance and address any issues in a timely manner. Research sites can leverage a clinical trial execution platform to generate reports that are tailored to the specific needs of site monitors.

These reports should include detailed information on inventory levels, sample collection and processing status, and any deviations from protocol requirements. By proactively sharing this data with site monitors, research sites demonstrate their commitment to transparency and compliance, facilitating smoother communication and problem resolution. Ultimately, this proactive approach not only streamlines the monitoring process, but also helps build trust and credibility between research sites and CRAs. 

Reduce your queries—and have query responses more readily available

Sites never like being bogged down by lab queries or EDC queries — especially when those queries result in more back-and-forth communication between study coordinators and site monitors. 

Minimizing the number of queries generated during a clinical trial not only saves time and resources but also enhances the overall efficiency of the trial. Research sites can achieve this by ensuring that all necessary documentation, including biospecimen data, sample audit trails, and chain of custody information, are readily accessible and up to date.

By proactively addressing potential queries before they arise, research sites demonstrate their commitment to compliance and protocol adherence. Additionally, having query responses readily available enables research sites to provide timely and accurate information to CRAs, reducing delays and facilitating smoother communication. 

Introducing the clinical trial execution platform that can transform your working relationship with your monitors

Slope’s clinical trial execution platform is your one-stop shop for inventory management and sample management across all of your trials. The software — which is free for sites — enables sites to standardize and digitize their processes for managing lab kits, IP, devices, bulk supplies, shippers, and other clinical supplies. 

Slope not only eliminates the need for paper and spreadsheets, but it enables sites to be better partners to their site monitors and sponsors. By automatically capturing all inventory and sample data in one digital location, sites can offer other study stakeholders with streamlined access to pertinent study data and respond to queries in a matter of seconds.

Click here to sign up for your free Slope account today. In the meantime, check out this case study, which demonstrates how Slope helped a cancer center streamline its trial operations and cut inventory waste.

Interested in learning more about the impact of today's clinical trial landscape on research site compliance? Click here.