How Can Clinical Research Sites Supplement the Training They Receive on Their Studies?
If you’ve ever worked at a clinical research site, then you’re familiar with the protocol-specific training that occurs when your site is initiated for a new study or when a new protocol amendment is rolled out. Given that almost every trial today has its own unique set of processes, coupled with a complex study design, this training has become increasingly critical for site staff.
ICH GCP guidelines also highlight the importance of training several times, stating that “each individual involved in conducting a trial should be qualified by…training,” and “risk reduction activities may be incorporated into…training in processes and procedures.”
Unfortunately, protocol-specific training can only go so far. The reality is that the majority of study coordinators and other site personnel are juggling several trials on any given day or week. Because of this, it’s nearly impossible to keep up with all of the procedures, vendor processes, systems, and study changes that characterize each trial. As highlighted in this 2023 Fierce Biotech survey, nearly 90% of biopharma professionals reported that their research sites sometimes miss required sampling timepoints, or have misplaced patient on-study samples.
So what can research sites do to improve their compliance with protocols, lab manuals, and other study documents, given that traditional training methods have inherent limitations?
Augment lab manual trainings with technology
Protocol training often includes a detailed overview of the various sample collections on a trial — including the collection, processing, storage, and shipping steps required for each sample type. Sites can also reference this information in the lab manual, but unfortunately this document is not very useful in practice, when site staff are frantically balancing multiple tasks across multiple studies and sponsors. Since protocol training usually only occurs at the beginning of the study and periodically throughout the study, it may only have a minimal impact on compliance with the lab manual. This is especially true given the fact that the lab manual is often a very dense document, and site staff don’t have the time to comb through details during patient visits.
Thankfully, technology can improve compliance by supplementing lab manual training with guided workflows that walk site staff through the various steps in the lab manual as they perform each procedure. This takes a significant amount of pressure off of study coordinators, who no longer have to rely on their memory or a 100-page lab manual to ensure they are following every sample management procedure to a T.
Streamline the rollout of protocol amendments
Let’s face it: sites already have their work cut out for them when it comes to keeping track of their various tasks, but protocol amendments further complicate site workflows. Many sponsors and CROs will offer training to sites on protocol amendments in an attempt to improve site compliance with study changes, but training alone isn’t sufficient for helping sites keep track of every single change that impacts lab kits, certain sample collections, requisition forms, storage and shipping procedures, and more.
As we highlighted in our blog, “How Can Research Sites Address Challenges with Managing Protocol Amendments on Their Clinical Trials?”, when sites leverage a software platform for inventory and sample management, they are able to roll out amendments and lab manual modifications across their entire organization as soon as they are approved under the new versions. This in turn supplements training efforts with streamlined process changes that further enforce compliance with any protocol changes that impact lab kits and sample management procedures.
Stay on top of lab and kitting vendor requirements with the help of technology that enforces compliance
Site training is also intended to inform sites about how to work with various labs and vendors — including how their processes work for ordering lab kits, how and when to ship to specific labs, and much more. Given the fact that every study may work with a unique set of labs and vendors, it can be incredibly challenging for site staff to keep up with vendor-specific requirements. This in turn can put sites at risk of shipping samples to labs on the wrong days, over- or under-ordering certain lab kits, and more.
The same guided workflow technology that was discussed above can also be used to help sites comply with their training on vendor- and lab-specific processes — including blackout dates for sample shipments, lab kit resupply schemes, and much more. By leveraging technology that keeps track of these study-specific guidelines on your site’s behalf, site personnel can focus more of their efforts on patient care and other critical tasks that require more attention.
Slope puts your site training into practice
While site training still remains a critical part of your processes, it’s not enough to rely on training as a way to maximize compliance with study procedures. With Slope’s free clinical trial execution platform for sites, clinical researchers can strengthen their compliance with the lab manual, ensuring that sites are able to seamlessly apply what they have learned in training to their actual processes. Slope not only orchestrates inventory management across your entire organization, but it takes your lab manuals and turns them into software-guided workflows that facilitate sample collection, processing, storage, and shipping. As sites perform study activities in the platform, the software also captures important sample metadata in real time, which sites can then use to ensure that requisition forms are filled out correctly.
To get started with your free Slope account, click here. In the meantime, click here to learn more about the other ways in which today’s clinical trial landscape impacts research site compliance.
