What Can Research Sites Do to Standardize Their Processes for More Efficient, Compliant Trials?
In our sponsor blog, “What Is Research Site Standardization, and What Does It Have to Do with Your Clinical Trial’s Centralized Monitoring Plan?”, we explored the notion that there is a lot of variation in processes both within and across research sites. Every study coordinator within a given site may have a different way of performing common study tasks, especially when it comes to responsibilities like inventory management. Even tasks that are already more standardized at a research site — like sample management — may involve site staff working with different kitting vendors and different lab manual formats as they navigate specific study requirements.
From the perspective of a research site, it’s easy to see why it has historically been so difficult for site staff to sync and standardize their processes. Every sponsor and clinical trial has its own unique set of requirements, along with its own unique set of lab kits, sample collection schemes, requisition forms, vendors, and more. When every study prescribes a different set of expectations for its sites, how can site staff be expected to execute on these tasks in a consistent manner?
The good news is that there are solutions that sites can implement to standardize their processes, especially when it comes to managing the elements of a clinical trial that are critical to study outcomes — clinical inventory, patient samples, and the sample metadata that is often captured on the requisition form. Here are three things that every site should consider as they strive to improve efficiency and compliance across their entire clinical research operation.
Use a centralized platform to catalog your lab kits
Are you tired of being the site that keeps track of clinical inventory with sticky notes and Excel spreadsheets? Are your site’s limited storage areas disorganized and overflowing with lab kits, making it difficult to find the lab kit you need or stay on top of expired inventory?
This doesn’t have to be your reality. Consider implementing a digital solution for managing your clinical inventory across your entire organization, enabling study coordinators to be on the same page when it comes to always knowing what supplies your site has on hand across all of your trials. This approach makes it easier than ever for sites to store and locate inventory, as well as monitor expiration dates and resupply orders.
Ditch lab manuals in favor of guided workflows for sample management
If your site runs several trials across several sponsors, then chances are your lab manuals come in every shape and size. One central lab may present the sample management procedures one way, while another central lab may present the same information in a completely different format. It also goes without saying that clinical trials are complicated, so their lab manuals tend to be incredibly dense.
It can be time-consuming and risky for sites to rely on these static documents to determine instructions for sample collection, processing, storage, and shipment for every sample collection on a single visit — as well as lab kit ordering requirements and blackout shipping days. Unfortunately, paper-based lab manuals lay the groundwork for sites to make significant mistakes when it comes to executing the routine responsibilities of a clinical trial. This is especially true when sponsors roll out study modifications that impact the lab manual in the form of changes to lab kits, sample collection supplies, sample management procedures, and more.
So what can sites do to combat these issues? Think about how you would prefer to perform a complex process — would you rather parse through the instructions for performing this complex process in a wordy, paper-based document, or would you rather leverage interactive technology that guides you through the process step by step, ensuring that you have all of the information you need to complete each procedure without risking overlooking or misinterpreting any instructions?
Check out solutions that eliminate your dependency on lab manuals altogether. Leverage technology to turn your lab manuals into guided workflows that facilitate every step of sample collection, processing, storage, and shipment. This ensures that site staff are following the same processes for every sponsor and every study, while improving their compliance with sample management instructions.
Make filling out requisition forms a breeze by automatically capturing sample metadata
Sites understand how much of a pain it can be to fill out requisition forms — especially when samples and the data associated with these samples changes hands multiple times. Even if sites have a “consistent” process for managing this information, it doesn’t negate the reality that multiple people are involved in capturing and recording the sample metadata that sponsors need in order process the samples downstream and demonstrate a comprehensive chain of custody.
Study coordinators often complain about filling out a paper-based requisition form prior to shipment, only to realize that the phlebotomist or nurse who performed the patient visit either didn’t capture all of the necessary information or didn’t capture the data correctly/legibly. Inevitably, the study coordinator either needs to spend precious time tracking down the information themselves, or submit an incomplete requisition form that will contribute to lab queries — putting critical samples and lab results at risk.
Sites should consider every opportunity to streamline the collection and handoff of sample metadata among site staff so that critical data points are never missed or lost in translation. Rather than waiting until filling out a requisition form or entering data in the EDC to discover that critical data is missing, illegible, or simply incorrect, consider solutions that digitize sample metadata so that critical data points are never overlooked or misinterpreted.
Slope is your free solution for standardizing clinical trial operations at your site
Gone are the days of every study coordinator having their own process for managing clinical inventory. Say goodbye to reading through dense, paper-based lab manuals that differ from sponsor to sponsor and lab vendor to lab vendor. Slope centralizes all of your site’s inventory management and sample management processes across all of your sponsors and trials so that your clinical research operations are more efficient and more compliant than ever before.
To learn more about how Slope can standardize your research site processes, get started with your free account. In the meantime, check out our blog with UPMC Hillman Cancer Center about their success with rolling out Slope for inventory management across all 12 of their disease centers.
To explore the impact of today's clinical trial landscape on research site compliance and sponsor monitoring strategies even further, click here.
