Oh No! My Research Site Experienced a Protocol Deviation, and It Was Our Mistake! What Now?
In the fast-paced world of clinical trials, the smallest oversights can have significant consequences.
Let’s imagine that your research site is screening a cancer patient for a promising oncology trial. Amidst the rush of conducting the patient visit and managing the patient’s samples, multiple missteps occur. The study coordinator accidentally pulls an outdated Screening kit and mistakenly overlooks multiple sample management procedures in a 100-page lab manual, resulting in vital samples for patient inclusion/exclusion assessments either not being collected or being sent to the wrong lab for testing.
As a result, a patient that was eager to explore a novel therapy and contribute to medical advancement now finds themselves having to screen fail for reasons that may have been completely preventable. Frustrated and disheartened, they decline an invitation to re-screen, potentially robbing them of a chance at life-changing treatment.
This scenario underscores the importance of meticulous research site compliance with protocols, lab manuals, and other study documents. How can sites ensure they, along with their patients, don’t fall victim to such devastating deviations? This blog explores some proactive measures that sites can implement to prevent these critical missteps.
Implement a better inventory tracking system so that you’re always on top of your lab kits
By adopting a robust inventory management process, research sites can minimize supply shortages, lost or expired lab kits, and outdated inventory. Digital inventory solutions can ensure timely replenishments of critical lab kits, bulk items, IP, and more. This proactive approach minimizes the risk of using outdated or depleted resources, safeguarding against preventable protocol deviations. Automated alerts and inventory optimization features — like inventory min-max thresholds — can also streamline workflow efficiency, freeing up valuable time for research staff to focus on patient care and compliance.
Let’s imagine how this solution could have prevented the scenario mentioned above. When the sponsor and kitting vendor updated the Screening kit in response to changes to the protocol and lab manual, the site could have quickly and easily evaluated all of their on-hand Screening kit inventory to ensure that any kits that were produced under a previous study version were discarded and replaced. Unfortunately, when sites lack a standardized process for keeping tabs on their inventory and instead rely on paper and spreadsheets, it makes it easy for them to lose track of which lab kits may need to be taken out of rotation in response to study modifications. Study coordinators may be prone to accidentally pulling an old version of a lab kit, not realizing that someone else in their facility hadn’t changed out the outdated kit.
Improve compliance with the lab manual using free sample management tools
Software solutions can offer guided workflows that offer step-by-step guidance for sample collection, processing, storage, and shipment—reducing the likelihood of errors caused by manual oversight. These tools empower research staff to adhere meticulously to study requirements, ensuring the integrity of collected biospecimens. In addition, automated reminders enhance compliance with sample storage and shipping instructions, promoting consistency across site staff. Embracing these tools not only simplifies complex processes, but also elevates the quality and reliability of research data so that patients have enhanced access to beneficial treatments.
How could this software tool have supported site staff in the above scenario? Imagine if study coordinators didn’t have to sift through dense lab manuals or build paper-based templates, and instead were able to leverage the power of guided workflows that walk site staff through every step of sample collection, processing, storage, and shipment. These built-in guardrails ensure that site staff are following every critical procedure and shipping samples to the right places, on the right days, under the right conditions. Unfortunately, with the complexity of and frequent changes to today’s clinical trials, it’s easy for sites to accidentally miss critical sample management instructions.
Capture your biospecimen data in a digital platform to defend against investigations
Using sample management workflows to automate and centralize the capture of biospecimen data can facilitate site documentation of critical data, enabling swift retrieval of information when responding to sample investigations and queries. These platforms can also offer robust audit trails, ensuring data integrity and accountability throughout the research process.
Additionally, digitized biospecimen data streamlines communication between research sites, labs, monitors, and sponsors, expediting responses to queries when they do arise. By embracing these kinds of solutions, research sites not only enhance their capacity for data management, but also demonstrate a commitment to transparency and regulatory compliance.
In the scenario above, let’s say the site didn’t experience a deviation and did everything correctly from an inventory and sample management perspective. If something were to happen to some of these patient’s screening samples downstream (i.e. in transit or at the lab), the sponsor or site monitor may start their investigation at your site. With the help of a digital platform that automatically captures the sample audit trail from kitting to delivery at the lab, sites are equipped to swiftly respond to any inquiry. Unfortunately, many sites track their audit trails on paper, making the retrieval of critical data cumbersome and time-consuming.
Introducing Slope: Your first line of defense against protocol deviations caused by human error
Slope’s clinical trial execution platform is free for sites, enabling site staff to streamline and standardize their management of clinical inventory, patient samples, and sample metadata across all of their trials and sponsors. Our centralized inventory management system is compatible with any lab kits and other forms of clinical inventory, enabling sites to digitize their processes for tracking on-hand supplies, storage locations, lab kit utilization, expiration dates, and resupply orders. Our guided sample workflows replace static lab manuals with software-based workspaces that facilitate every step of sample management at the site — from sample collection to shipment. Our sample journey view also brings the sample audit trail and chain-of-custody data together in one place so that sites can quickly defend against queries and sample investigations.
Interested in learning more about how Slope can support your site? 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. In the meantime, check out this case study, which demonstrates how Slope helped a cancer center streamline its trial operations and cut inventory waste.
To explore the other ways in which today’s clinical trial landscape is hindering sponsor monitoring strategies and research site compliance, check out our guide, "Dissecting the Link Between Clinical Trial Monitoring and Research Site Compliance."
