How Can My Research Site Prevent Sample Mishandling?

The majority of study coordinators, phlebotomists, nurses, and clinicians who work at clinical research sites chose their profession because of their passion for supporting patients. Clinical trials are particularly exciting because they offer patients access to promising treatments that have the potential to save their lives or dramatically improve their quality of life.

But let’s take a moment to consider one of the most important forces behind a clinical trial — patient samples. Samples are crucial to determining a patient’s treatment plan, as well as their ability to enroll and stay enrolled on a trial. But beyond that, samples provide sponsors with invaluable data that they use to determine the safety and efficacy of a drug. If the data is positive, then the treatment has the potential to reach a larger patient population.

When we choose to work in clinical research, we are also holding ourselves to the highest standards of integrity. The trials that we support have significant implications for some of our most vulnerable populations. For that reason alone, shouldn’t we be doing everything we can to prevent the mishandling of patient samples?

Unfortunately, the reality of today’s clinical trial landscape makes it harder than ever for traditional sample management processes to keep up. Every trial has complex sample requirements, and the clinical supplies that sites are required to use to collect the samples are equally complicated. Sites are often given dense lab manuals and protocols to guide them through sample management requirements for the trials they support, but these resources have major limitations. It can be extremely easy for site staff to accidentally overlook or misinterpret key sample procedures — resulting in increased patient burden, higher query rates, and more.

So what can sites do to better uphold their commitment to the patients they serve? What aspects of sample management should sites address if they want to maximize the integrity of their research operations?

Make sure you are collecting all of the required samples in the first place

While this may seem obvious, sample collections that are missed due to human error are a common occurrence in clinical research. These missed samples create critical gaps in clinical trial data, especially if the samples are tied to inclusion/exclusion criteria or primary/secondary endpoints. Without these samples, patients may not be able to enroll in a study, stay enrolled in a study, or may be asked to come back in for a sample redraw. These scenarios also create more work for site staff, who have to respond to more queries and sample investigations while documenting a greater number of protocol deviations.

Consider implementing processes that make it less likely for site staff to overlook mandatory sample requirements. The schedule of events in the protocol or lab manual can be extremely complicated, but fit-for-purpose technology can enable sites to ensure that none of their critical sample collections are missed.

Don’t accidentally overlook sample processing instructions

Lab manuals often include detailed procedures for how a sample should be processed once it has been collected. In many cases, samples may need to be centrifuged, transferred to a separate return container, aliquoted, treated with a solution, and more.

Unfortunately, these instructions can get lost in the shuffle. When the sample is received downstream, the lab may be forced to cancel testing, simply because the sample was not received in the correct return container or processed appropriately.

Consider implementing safeguards that make it easier for site staff to keep tabs on sample processing steps while processing is being performed. When site staff are obligated to confirm the completion of each step, it adds an additional check to ensure that sites aren’t missing key steps.

Keep tabs on samples that you have to keep in storage

Sites know this better than anyone, but sample storage instructions tend to be all over the place. When you multiply the number of sample types on a single trial by the number of on-trial patients, and magnify that by dozens or hundreds of studies that may be supported by a site, it can be dizzying to think about how sites should keep track of their stored samples.

This is especially true because every sample may have unique instructions for storage. For instance, some samples may need to be sent the day of collection, but only after they’ve been frozen at a specific temperature for a certain span of time. Additionally, many sample types may need to be shipped in batches on a weekly or monthly basis. Without the ability to keep tabs on all of these samples, it can be easy for sites to lose samples or forget about samples in their freezers.

Sites should look into sample management solutions that allow them to track all of their stored samples at any given time. Better yet, consider solutions that will actually alert site staff when a certain sample is ready to ship based on the shipping frequency defined in the lab manual.

Be meticulous about making sure you’re shipping your samples correctly

It goes without saying that clinical trial sample shipments are extremely complicated. A single protocol may have samples going to several different labs — and each of those labs may have specific requirements for shipping, including their own specific requisition forms, couriers, shipping days, packaging guidelines, and more. It’s a lot to keep track of — and because of that, samples are more likely to be sent to the wrong location, on the wrong days, or in the wrong condition.

Sites should consider implementing guardrails to bolster their sample shipping procedures. Worried about shipping a sample to the wrong lab by accident? Look for solutions that help site staff ensure that their samples are assigned to the correct shipping destination. Concerned about shipping samples on blackout days? Consider solutions that automatically keep track of shipping blackout days for certain labs, so site staff doesn’t have to.

Provide your sponsors and CRAs with defensible sample data

A discussion of sample management would be incomplete without a conversation about data. Anytime samples are collected for a patient visit, they must be accompanied by sample metadata that travels with the sample on requisition forms, in the EDC, and more. These data points — including visit and study information, patient demographics, collection dates and times, and administrative information — are critical to downstream sample testing, as well as overall data integrity.

Source data is often captured as sample management activities are being performed, but it’s easy for site staff to forget to record some of the data, given the complex nature of today’s requisition forms and gaps in research site processes. Sample data often changes hands multiple times at a site, so the person who fills out a requisition form or enters data into the EDC may not be the same person who initially captured the data. This means that study coordinators may have trouble tracking down information that wasn’t initially collected, or otherwise may accidentally commit transcription errors when filling out written forms.

Sites should consider solutions that automatically capture sample metadata as sample management activities are being performed. This dramatically improves site efficiency and reduces the risk of critical data points being missed.

Slope is your free sample management guide

Each and every one of us should be prioritizing our role in improving clinical trial sample management. Slope makes it easy for sites to play their part thanks to our free clinical trial execution platform, which uses software-guided workflows to walk site staff through sample collection, processing, storage, and shipping. Because the platform is pre-configured prior to use in a patient visit, sites no longer need to rely on lab manuals or templatized versions of the lab manual in order to perform their sample-related tasks. Our software ensures that staff never miss an important step, while simultaneously capturing important sample metadata that is used to generate or fill out requisition forms and shipping manifests, demonstrate sample chain of custody, and defend against queries.

To see for yourself how Slope has helped research sites streamline their sample management processes, sign up for a free account today. In the meantime, click here to learn more about the impact of today's clinical trial landscape on research site compliance.