Accurately capturing and communicating sample metadata across various sites and labs can significantly impact the success and efficiency of a study — influencing everything from decision-making to the ability to report lab results.
For this reason, reconciling sample metadata is a crucial process in executing a clinical trial — but it’s only necessary because of inefficiencies that exist around collecting and sharing this data across several stakeholders. Lab requisition forms play a critical role in the dissemination of sample metadata, so it’s important to understand how and why traditional requisitions may actually be contributing to the need for reconciliation.
Traditionally, clinical trial sponsors have relied on paper-based requisition forms to collect sample metadata from sites and communicate this data to labs. However, the industry is becoming increasingly eager about the widespread adoption of electronic requisition forms, driven by the need to streamline processes and mitigate risks.
So when it comes to reducing the need for data reconciliation, what limitations do paper-based requisitions present? What are the advantages of digitized requisitions, and how can sponsors use these e-requisitions to drastically improve the management of sample metadata?
As with any paper-based process, traditional requisitions come with a whole host of issues. Despite our industry’s best attempts to optimize these forms, the absence of technology in capturing and disseminating sample metadata to labs introduces several risks that require a greater amount of reconciliation.
One of the most significant drawbacks of paper-based requisition forms is the necessity for duplicative data entry. Each piece of data must often be manually transcribed multiple times across various documents and systems, such as EDC systems and lab databases. This repetitive process is not only time-consuming but also fraught with risks, including:
Conversely, electronic requisition forms eliminate the need for redundant data entry through seamless integrations with EDC, LIMS, and other clinical systems. This not only saves time, but also significantly reduces the number of queries that require resolution.
Paper-based forms are inherently prone to legibility issues. Handwritten entries can be difficult to read, and issues such as poor handwriting or smudging can further complicate data interpretation. Additionally, the use of carbon copies or photocopies can degrade the quality of the handwritten data, making it even harder to read and increasing the likelihood of errors.
Electronic requisition forms solve these problems by ensuring that all data is captured digitally. This guarantees that the information is legible and consistently clear, eliminating the risks associated with poor handwriting and other legibility issues.
Another challenge with paper-based requisition forms is the lack of consistency in data specifications across various study stakeholders. Different labs may have varying requirements for how data should be formatted and what information needs to be included on a requisition form. This lack of standardization can lead to discrepancies and delays as data is reconciled and re-formatted to meet the specific needs of different stakeholders.
Digital requisition forms address this issue by enabling consistent data capture across all vendors. Through pre-programmed integrations, these forms ensure that all necessary data is collected in a standardized format that is compatible with downstream labs and data vendors. This not only streamlines the data reconciliation process, but also ensures that the data is accurate and reliable from the outset.
Clinical trials often involve amendments and modifications that can impact the sample metadata that is collected on the requisition form — including collection dates and times, and preanalytical variables. When paper-based forms are used, implementing these changes can require pulling old versions of the requisition forms out of circulation (along with the lab kits that these requisitions are often associated with) and ensuring that only the new versions are used. Unfortunately, this process is prone to oversight and logistical difficulties.
In contrast, digitized requisition forms enable seamless transitions to new amendments or any other study changes that may impact the sample metadata that is captured. As soon as a change is made, the new version is instantly available to all sites who are approved for the change, ensuring that outdated forms are not used. This immediate update capability is crucial for maintaining compliance and accuracy throughout the duration of the trial.
Slope’s biospecimen lifecycle software, Biospecimen360™, is designed to revolutionize the way sponsors handle biospecimen metadata. By capturing sample metadata as sites perform sample management activities, Slope can generate e-requisitions that enable the following benefits:
To learn more about Slope’s e-requisition solutions, click here to speak with one of our experts.