Ultimate Guide to Managing Biological Samples for Sites

As clinical researchers, your first responsibility is running your clinic and treating your patients

You care that supplies are available for your patients and that critical safety, efficacy, and exploratory lab samples get where they need to be. You understand the impact of lost or invalid samples on the patient and the repercussions improper sample management has on the safety and efficacy data and the overall integrity of your study.

Unfortunately, the process of collecting, processing, storing, and shipping samples is chaotic at best. There is very little training or time to truly decipher the lab manual when a patient is waiting, and the clock is ticking. On top of that, you are dependent on having the most current version of the ever-changing laboratory manual. This results in poor user experiences for the site coordinators and lab staff.

So what are you supposed to do? Typically, you follow your SOPs as best as possible, knowing that the process isn’t perfect and there is little to no visibility into the samples’ state or location once they leave your site; knowing that those samples are critically important to prove the safety and efficacy of the treatment; and trusting that you can connect the dots between the lab results and the patient by piecing together information from disparate sources.

We’ve created this guide to help you better manage your samples and gain control over your supply chain while focusing on your core responsibilities around your clinic and your patients.


What is Sample Management?

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The Sample Management Process

Sample management is the process of collecting, processing, storing, shipping, tracking, analyzing, and resulting biological samples from patients with appropriate data recorded per the protocol and lab manual’s instructions.

The sample journey is the path the biological sample takes from collection all the way to analysis at the receiving lab. While every site’s practices may vary, typically, the steps you take for sample management are as follows:

  1. Collecting Decipher procedures for sample collection as described in the protocol and associated lab manuals. Ensure the correct clinical supplies are available for the patient visit. Meet with the patient, run safety checks, and collect the sample if deemed appropriate.
  2. Processing Complete processing per the lab manual.
  3. Storing Record the necessary data, including the chain of custody information, while storing the sample.
  4. Shipping Ship the sample to the lab for analysis.
  5. Tracking Track the sample throughout the sample journey.
  6. Analyzing Receive and analyze sample results.

But to you and your site, it is more complex than that: Sample management is a critical piece of your job, however, you’re confronted with competing priorities within your responsibilities. You are expected to execute intricate sample management procedures with little training and complex instructions. You are constantly wondering if you have the necessary lab kits and supplies to complete the visit, or if what you have on hand is already expired. You do your best to follow sample processing and shipping condition requirements. You hope that once the sample leaves your site, the sample gets to the right lab and provides valuable safety and efficacy data. You do your best to document the entire sample journey when there are so many moving parts, knowing that your study monitors will have questions during their periodic visits.

Each step your site takes for the sample journey has challenges and risks, which is why sample management is one of the most involved yet essential processes in a clinical trial.


The Top 5 Complex Trial Types that Rely on Sample Management

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Best Practices for Sample Management

We understand the challenges you face managing samples for complex clinical trials. You are doing your best to keep your trials on track and your patients safe. That’s why we’ve compiled a list of best practices that can help alleviate some of the pressures you face every day.

Be proactive

While initial training on a complicated protocol is helpful, there are instances where it consists of reading off a PowerPoint presentation. Don’t wait to get your questions answered as the study progresses. Utilize every opportunity to identify possible risks and gain alignment around sample procedures that may be vague. If not all information is known at study start, don’t be afraid to consult your CRA, and continue to leverage ongoing training sessions.

Create quick reference materials

Lab manuals are information-dense, so it’s crucial to request reference materials from your sponsors or CROs and maintain open communication to receive updated versions.

Creating quick reference guides and SOPs specific to the study can also be helpful. These guides should highlight any unique aspects and ensure alignment within the site. By using these guides, you can save time and quickly determine the next steps for sample management, which is especially important when patients are waiting.

Build an audit trail

Every action performed must be documented, including the clinical inventory used, how it was processed, and by who, shipping details, etc. Many sites use spreadsheets to track kit quantities, paper records of coordinator activity, and they do their best to cobble together the sample journey. This documentation involves transcribing your notes from paper or from system to system, and must be done in a timely manner to ensure accuracy. Even though manual processes are time-consuming, collecting this information as it happens helps protect your site, especially if a problem surfaces. It is important to remember that the audit trail needs to clearly detail all the decisions made along the way, including changes in instruction and who they were provided by.


The Impact of Poor Sample Management

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Piece together the sample journey

You’ve shipped the samples and are now waiting on the receiving lab for results. As one of many overlapping priorities, piecing together the sample journey may be overlooked unless an issue arises or when other stakeholders inevitably start asking questions. Your CRAs or monitors want to know where the samples are, and if everything is going to plan. Labs will query the samples they’ve received using their own platforms. This can cause undue stress as the coordinators start digging through their own records to find answers.

To ensure a smoother sample journey, we recommend actively collaborating with your sponsor or CRA to clarify logistics and communication pathways. This will provide greater insight into the sample journey and allow you to confirm important details such as the optimal days for shipping samples to labs.

Keep the shipping records handy

Even with one patient, there can be a multitude of samples going to a multitude of labs. Compounding that by the number of patients you are enrolling, you can be inundated with shipping records.

Scanning and saving paper shipment records in a shared drive can help you mitigate risks while the sample is en route. Considering the reduced visibility after shipping we touched on, it is worth it even if it means copying each shipment record multiple times and affixing each one individually to a shipping record. The last thing you want is to have no record of a sample you must recollect due to shipping errors.

Be prepared to handle sample discrepancies

It happens. Months after you’ve received results, your monitor informs you that there was a discrepancy with the sample. Or the lab queries and says they never received the sample. Or, while looking at the sample, you realize the sample was received by lab personnel out of the temperature window and its viability was compromised.

If that happens, try not to panic. By following good documentation practices, you can be prepared to handle sample discrepancies. It is important to follow the mantra “If it wasn’t documented, it didn’t happen.” While you can’t anticipate everything that could go wrong, by maintaining accurate documentation, you can get ahead of potential discrepancies. Clarifying expectations regarding documentation and maintaining SOPs for documentation are key.

Another best practice is to employ a risk-based monitoring approach. By listening and learning from past monitor feedback, you can identify sample collections, etc., with an elevated risk of user error. This helps ensure you won’t repeat the same mistakes moving forward.

Develop internal SOPs for sample management

Taking all the other best practices into consideration, one of the most helpful recommendations would be to take the time to consolidate them into an internal SOP for your site for sample management. Hopefully this can help streamline your existing processes and help alleviate some of the challenges.


FDORA, Regulatory Risk, and Sample Traceability - A Q&A with Edye Edens

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Looking Forward: A Better Site Experience

We know that issues are bound to arise even if you follow every best practice for sample management. Thankfully, there is a better way.

Slope offers an innovative software solution that brings the best-in-class sample management capabilities to research sites struggling to address their biological sample collection, processing, storage, shipment, administration, and traceability challenges. Of course, good sample management practices also benefit from strong inventory management practices. Learn more about Slope’s inventory management solution at slopeclinical.com/platform/real-time-inventory.

Technology developed for sites

Slope’s objective is to empower sites with a scalable sample management solution geared for site-specific clinical operations challenges. Every new feature and workflow was vetted by research site clinicians, to make their jobs easier. If it didn’t enable them to spend less time with spreadsheets and more time with their patients, Slope didn’t consider it a viable option for improving how samples are managed at research sites.

Protocol-guided sample management workflows

Slope’s platform can be configured to the protocol, providing the coordinator with an accurate record of which samples have to be collected from each patient. As a result, sites can be confident they are adhering to the most recent IRB-approved version of the protocol and lab manual. The platform makes day-to-day operations much more efficient and supports stronger adherence for your sponsor.

Traceable chain of custody

With Slope, sites no longer have to piece together a sample’s journey by comparing EDC records against site patient records and making assumptions in the middle. Slope provides tracking for biological samples throughout their sample journey, from collection to lab receipt and analysis, while ensuring that every sample gets to the right lab, at the right time. Our sample management solution provides true oversight, all in one easy-to-use platform.

Enable better patient experiences

Patients are human beings, and providing a sample can sometimes be challenging for those with poor health. Better sample management enables better patient experiences. And better patient experiences contribute to the development of life-saving treatments.


The Top 5 Questions to Ask Your Trial Partners About Sample Management

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