Using EDC and Paper Requisition Forms to Capture Data for Sample Tracking? Here’s Why That’s Not Effective.

Sample metadata is critical to executing a clinical trial. Every bit of information about biospecimens — including sample and visit identifiers, collection dates and times, patient demographics, and pre-analytical variables — not only demonstrates the integrity of patient samples, but also gives sponsors valuable insight into site performance, study milestones, and more.

For the vast majority of patient samples, most of this data is generated at their point of origin — research sites. Since site staff are responsible for collecting, processing, and shipping the samples to downstream testing labs, they are oftentimes also the ones collecting critical source data that is then used by other study stakeholders to understand the makeup of a sample.

Consider the ways in which sponsors and labs access data about samples. Labs use requisition forms to accession samples into their respective databases, but these forms may be prone to errors that either trigger lab queries or merit reconciliation months after the sample has been collected. Sponsors can often access data about their samples through various lab portals and the EDC, but queries may either block sample data from being visible or may result in the data being inaccurate.

So what risks does this pose for sample tracking? Why is it critical for sponsors to address these risks? And what data do sponsors need to capture more efficiently at their sites in order to improve their sample tracking processes?

Relying on requisitions and EDC data for real-time, accurate sample tracking comes with inherent risks

EDC systems and paper-based requisition forms have long been the standard for capturing sample metadata at the site and sharing that data with sponsors, labs, and CROs. These data capture methods involve recording crucial information such as visit and sample identifiers, collection dates and times, patient demographics, and pre-analytical variables. While both requisitions and the EDC still play a critical role in clinical research, their current use in sample tracking presents significant drawbacks.

• Inaccurate data entry: Human error is an inherent risk when data is manually entered into EDC systems or on paper forms. Mistakes such as typos, omissions, and misinterpretations can lead to inaccurate or incomplete data. This in turn can compromise biospecimen quality and study outcomes, while hindering sponsor visibility to accurate information about their samples.
• Fragmented data: EDC systems and paper forms often operate in silos, making it difficult to consolidate and standardize data across different systems and stakeholders. This fragmentation can result in inconsistencies and discrepancies that are challenging to reconcile, delaying the study and increasing costs.
• Delayed data access: The process of manually transcribing data from paper forms into digital systems — and then sharing it with stakeholders — can lead to significant data lag. By the time sponsors and labs have access to the data, it may no longer be useful for real-time decision-making, or it may even delay the ability to make certain trial-related decisions.

Access to clean, real-time metadata is necessary

Access to accurate, comprehensive sample metadata in real-time is crucial for several reasons. It ensures that stakeholders can make informed decisions quickly, improves the integrity of patient samples — and ultimately, enhances overall efficiency and study success.

• Improved decision-making: Having real-time access to accurate sample metadata allows sponsors and labs to make timely decisions about sample analysis, monitoring, study design, and more. This can lead to accelerated study milestones and more reliable study outcomes.
• Enhanced sample integrity: Real-time data access helps maintain the integrity of biospecimens by ensuring that samples can be processed and tested as soon as they arrive at the lab. This reduces the risk of queries or delayed lab results, which can otherwise compromise study milestones. 
• Streamlined operations: Near real-time data access facilitates smoother collaboration between sites, sponsors, and labs. It minimizes the need for redundant data entry and manual reconciliation, thereby reducing administrative burdens and accelerating the overall clinical trial lifecycle.

What sample metadata do sponsors need access to?

Sponsors need access to a wide range of sample metadata to effectively manage and monitor biospecimens throughout the clinical trial. Key types of sample metadata include:

• Visit and sample identifiers: Unique sample and visit identifiers are crucial for tracking and managing biospecimens throughout their entire lifecycles. These identifiers ensure that each sample is correctly linked to the corresponding patient study protocol, visit, patient, and sample ID. They also help prevent mix-ups, ensure accurate data matching, and facilitate efficient sample tracking.
• Collection dates and times: Accurate collection times are essential for tracking sample stability from collection to analysis. They help ensure that samples are processed within the required timeframes and that any deviations are promptly identified and addressed.
• Patient demographics: Detailed demographic information — such as age, sex, and medical history — provides valuable context for interpreting study results and demonstrating the patient’s eligibility for the trial. It also enables sponsors to analyze data subsets and identify trends that may be influenced by specific patient characteristics.
• Pre-analytical variables: Factors such as sample processing history and administrative data can significantly impact how biospecimens are processed and tested downstream. Capturing these variables helps sponsors and labs assess what testing to perform and what processing steps to complete after the sample has left the site.

Slope enhances the ability to capture and access sample metadata from sites

Slope’s Biospecimen360™ software addresses the limitations of traditional sample tracking methods by capturing sample metadata from sites in real time. Our platform ensures that data is collected accurately and efficiently, providing immediate visibility to both labs and sponsors. 

Here’s how:

• Real-time data capture: Biospecimen360™ enables sites to capture sample metadata as they perform sample management activities. This real-time capture eliminates delays and ensures that the data is always up-to-date and readily available for stakeholders.
• Software-enforced guardrails: To ensure the accuracy of sample metadata, our platform incorporates software-enforced guardrails that guide users through the data capture process. These guardrails help prevent errors by enforcing standardized formats and ensuring that all required fields are completed.
• E-requisitions and integration with EDC and LIMS: Biospecimen360™ seamlessly integrates with EDC systems, eliminating the need for duplicative data entry and reducing the risk of data discrepancies. Additionally, integration with lab databases streamlines the accessioning process at downstream labs, further enhancing operational efficiency.
• Comprehensive data visibility: By providing a centralized platform for capturing and managing sample metadata and sample tracking data across the entire biospecimen lifecycle, Slope ensures that all stakeholders have access to a single source of truth. This comprehensive data visibility facilitates better collaboration, improved efficiency, and better informed decision-making throughout the trial.

To learn more about Biospecimen360™'s end-to-end sample tracking solution, click here to request a demo.