Understanding Clinical Research Site Challenges with Biospecimen Data Entry and Reconciliation
It goes without saying that clinical trial integrity and study outcomes hinge entirely on data. Sponsors and regulatory authorities use lab data to determine the safety and efficacy of a drug, but they also require even more data (also called biospecimen data or sample metadata) to confirm the integrity of the samples that were tested to yield the safety and efficacy data.
Sponsors and regulatory bodies like the FDA care a lot about having accessible, clean sample metadata. Unfortunately, the process of capturing this data, making this data accessible to other study stakeholders, and cleaning this data up requires a lot of work. As the owners of the majority of the source data and the stewards of patient samples, research sites shoulder much of this burden. They must collaborate with sponsors and various vendors to both provide them with source data, ensuring both its completion and accuracy.
So what challenges do sites face when it comes to capturing sample metadata and reconciling it? What solutions are available to sites that want to alleviate some of these burdens?
Data entry takes a lot of time
Research sites already have a lot on their plate when it comes to patient care, managing clinical inventory, and handling their patient samples. These tasks are only compounded by the fact that sites also have to meticulously document the chain of custody of every sample, as well as the sample metadata that is captured in source documentation, on requisition forms, and eventually in the EDC.
Recording data points — including patient demographics; site, visit, and sample identifiers; collection dates and times; and administrative information that is pertinent to sample testing and processing — occurs across multiple touch points at the site. In sum, these highly manual, repetitive processes add up to significant resource demands that boil down to entering the same data across multiple documents and systems.
Repetitive data entry puts the data at risk
Not only does manual, duplicative data entry require time and resources, it also increases the vulnerability of the data. Each time data changes hands, it often needs to be re-recorded from source documentation onto requisition forms and into the EDC. This manual re-recording of data ultimately introduces serious risks, including transcription errors and lost data. These lapses in the handling of important sample metadata can lead to integrity issues that result in queries, deviations, and regulatory violations.
Data reconciliation diverts important resources from other important tasks
Whether responding to the barrage of phone calls, emails, and alert notifications from labs; sifting through paper-based documents; fielding on-site monitoring visits; or spending hours cleaning up EDC data, the process of making sure that sample metadata is accurate and complete is often time- and resource-intensive.
The need for reconciliation and query resolution often stems from preventable errors, like blank fields on requisition forms or incorrect collection times entered into the EDC versus the source documentation. When sites are already spending so much time and effort making sure that they are completing basic tasks correctly the first time, they shouldn’t have to waste their precious time addressing avoidable mistakes.
Excessive data reconciliation can have far-reaching consequences beyond resource diversion. Having to correct these errors can also strain sponsor relationships, especially if discrepancies put critical study milestones like patient enrollment and database locks in jeopardy. Data reconciliation also can cause delays in the reporting of results that are critical to patient safety and treatment decisions.
Slope makes EDC data entry, requisition form completion, and query resolution a breeze for sites
Slope’s clinical trial execution platform completely revolutionizes the way that sites handle sample metadata. Our platform’s guided workflows for inventory and sample management translate lab manual procedures into facilitated instructions that sites can then use to automatically capture the sample metadata that’s normally captured on paper requisition forms and in the EDC. Slope’s software not only ensures that critical data points are never missed, but it also makes the data easily accessible for subsequent data entry and query defense.
Sites can leverage Slope across all of their trials and sponsors free of charge, but they can also advocate for Slope’s integrations with labs, EDC systems, and more — both with their sponsors and on their own IIT programs. These integrations not only eliminate the need for duplicative data entry, saving site staff countless hours each week, but they can greatly reduce the number of lab queries and EDC queries that sites receive due to discrepancies.
To learn more about how Slope can transform the way that your site manages sample metadata, click here to get started with your free account. In the meantime, check out our guide on research site compliance to learn more about how your site can improve compliance with lab kit management, sample management, and more.
