Getting to the Root Cause of Avoidable Protocol Deviations and Violations

As we uncovered in our blog, “Oh No! My Research Site Experienced a Protocol Deviation, and It Was Our Mistake! What Now?”, sites can minimize preventable protocol deviations by implementing certain best practices. But in order to understand why these strategies are effective, it’s crucial to dig into the factors that cause avoidable violations in the first place.

It’s important to note that some deviations are out of a site’s control — especially if they are attributable to external factors. For instance, a site may need to perform a research visit outside of the timeframe that is mandated in the protocol due to the patient’s schedule. 

Other violations, however, may be attributed to site compliance issues. These deviations have the potential to significantly impact the patient experience on a trial, as well as the integrity and outcomes of a study. Patients may be forced to screen-fail, withdraw from a study, or repeat sample draws as a result of deviations from prescribed study procedures. These gut-wrenching scenarios not only jeopardize the patient experience, but they can seriously compromise sponsor trust in a site’s ability to execute trials responsibly. 

Fortunately, many of these serious deviations are preventable, especially with the right systems and processes in place. This blog explores the core reasons behind these avoidable deviations, shedding light on key areas where improvements can be made. By addressing these issues at their root cause, sites can enable more streamlined and compliant clinical trial operations.

Your lab kits are disorganized

When sites accidentally lose lab kits or are not able to keep track of on-hand quantities, expiration dates, or resupply orders, it’s easy for research staff to be ill-equipped for patient visits. As a direct result of lost or expired inventory, sites may have to reschedule patient visits or build their own lab kits using supplies that they have on hand. In theory, piecing together a workable lab kit may sound like a sufficient workaround, but this can lead to oversights during sample collection and processing, incorrect labeling, or incomplete documentation — all of which can contribute to deviations from study documents. 

Implementing a robust inventory management system can mitigate this issue by ensuring that sites always have lab kits on hand that are already properly assembled, labeled, and readily accessible for use. By centralizing inventory data, maintaining awareness of low inventory and expiration dates, and streamlining reordering processes, research sites can maintain adequate stock levels and reduce the likelihood of protocol violations due to missing or expired supplies.

You aren’t collecting or processing samples the right way

Lab manuals often have very specific instructions for how samples should be collected and processed. Site staff are expected to follow these procedures to a T, or else run the risk of deviations and downstream issues with sample analysis. Whether it’s improper sample collection techniques or failure to adhere to specific sample processing instructions, these deviations can compromise the accuracy and reliability of study data. 

Implementing standardized workflows can help ensure consistency and compliance when it comes to sample collection and sample processing. By providing staff with software-guided guardrails that remove the need to reference static lab manuals, research sites can minimize the risk of study violations related to missing critical sample management steps.

You aren’t storing or shipping samples per the lab manual

Proper storage and shipping of clinical samples are critical to maintaining sample stability and integrity. Deviations in storage conditions or shipping procedures can result in sample degradation or loss, rendering them unusable for analysis. 

Research sites must adhere closely to the guidelines outlined in the lab manual to ensure the proper handling of patient samples. In order to guarantee compliance with sample management procedures, sites should have processes in place to ensure that biospecimens are stored and shipped at the appropriate temperatures, shipped to the right labs in the right shippers, and never shipped on blackout days.

Your site is struggling to stay up-to-date with amendments and modifications

Protocols and lab manuals are dynamic documents that may undergo amendments or modifications over the life of a study. Failure to comply with these changes can lead to inadvertent deviations from the most current version of study documents, putting patients and the validity of study data at risk. 

Research sites must establish robust processes for ensuring the timely and successful implementation of study changes. This may involve exploring solutions that streamline the rollout of amendments and lab manual modifications. By proactively managing these changes, research sites can minimize the risk of protocol deviations and maintain compliance with the most up-to-date study requirements.

Your workflows for handing off patient samples and biospecimen data are increasing your risk for error

Manual data recording processes and fragmented communication channels can all contribute to deviations from the study protocol. For example, site staff may accidentally assign certain samples to the wrong patient ID, resulting in critical lab results being reported for the wrong patient. Research sites must streamline sample handling workflows and implement data solutions to reduce the risk of errors and protocol violations. 

By leveraging technology to automate the capture and transfer of sample metadata — including patient demographics, collection dates and times, and other administrative information — research sites can improve efficiency and accuracy in handing off data from one staff member to another, completing requisition forms, and entering data into the EDC. This not only enhances compliance with study documents, but also reduces the likelihood of errors that could impact study outcomes. 

Slope stops preventable protocol deviations before they happen

Addressing the root causes of avoidable protocol deviations is paramount to maintaining the integrity and success of clinical trials and ensuring a seamless patient experience. By focusing on improving processes related to lab kit organization, sample management, amendment implementation, and workflow efficiency, research sites can enhance compliance and reduce the risk of protocol deviations.

Slope’s clinical trial execution platform is free for sites, and is your most important tool for improving compliance with inventory management, sample management, and the handling of sample metadata. 

Click here to get started with your free Slope account and see for yourself why we are trusted by over 75% of NCI-designated cancer centers. To see firsthand how Slope helped a cancer center streamline clinical trial operations and cut inventory waste, check out this case study. 

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