How to Reduce EDC Queries at Your Research Site

If you work at a research site, chances are you’re extremely familiar with the EDC. In most cases, sponsors rely on the EDC to access site-generated data pertaining to any samples that are collected for their trial. 

Not only is the EDC an intrinsic part of day-to-day site operations, but it’s the driving force behind site payment for their participation in a clinical trial. The sooner that sites are able to provide clean, complete data to sponsors, the better.

Unfortunately, the importance of the EDC doesn’t negate the reality that EDC management diverts precious resources from clinical research teams. This is especially true when we consider the amount of time that sites have to spend addressing discrepancies and missing information in the EDC. These queries run the gamut from incorrect collection dates and times, to missing patient demographic details.

A lot of effort goes into manually addressing even one EDC query. Source data may be scattered across various physical and digital locations, making it time-consuming and challenging for sites to verify and access the data they need to resolve queries. 

Given the complexity of today’s trials, coupled with the limited resources and high workload that sites already face, what can site staff do to reduce their EDC query burden? Here are three possible solutions to consider.

Optimize your site workflows to get your EDC data right the first time

EDC queries often stem from sample information — like collection dates and times, patient demographics, and other critical data points — that is missing from the EDC altogether, or deviating from what has been captured in source documents and lab databases.

These gaps and inconsistencies in sample metadata may stem in part from inefficiencies in site processes for capturing the source data that is subsequently entered into the EDC. For instance, site staff may forget to collect certain data points while they conduct a patient visit — leaving the person entering the data into the EDC with no choice but to leave certain fields blank. Additionally, the data for a single sample may change hands several times across various site personnel before it is entered into the EDC, meaning sites may be more prone to submitting the wrong data. 

Consider solutions that enable sample metadata to be captured automatically, as basic sample management tasks are being performed. This process dramatically improves compliance because it ensures that important data points are never overlooked or lost in translation during or soon after a patient visit has been performed. The result? Fewer queries that require reconciliation and massive time savings.

Digitize your sample metadata for easy access during EDC data entry and reconciliation

The sample metadata that is eventually entered into the EDC may be spread across various paper-based and electronic documents. Consider solutions to consolidate your sample metadata in one central location so that it’s easily accessible and searchable when it comes time to enter data into the EDC. Digitized sample data can also come in handy when you’re investigating an EDC query — perhaps even offering additional context that could explain why the query was raised in the first place. These tools can save your site countless hours on EDC query management so that you can reallocate your resources to other important tasks.

Call on your sponsors to support EDC data integrations

Anytime a process requires repetitive, manual entry of the same data across multiple systems, it increases the risk for errors that lead to EDC queries.

Imagine if sites could cut down on the amount of work they have to do on the front end, and the amount of reconciliation they have to perform, simply by reducing the amount of data that they have to enter into the EDC altogether.

Consider asking your sponsors to implement solutions on your trial that eliminate the need to enter the same sample metadata in multiple places. This increases consistency and accuracy of the data across various systems and documents, eliminating one of the root causes of data discrepancies. 

Slope is your free companion to the EDC

When sites implement Slope, they gain access to guided sample management workflows that help them automatically capture the data their sponsors expect to see in the EDC — like collection dates and times, patient demographics, preanalytical variables, and more. This ensures that critical data points are never missed during a patient visit, making EDC data entry a breeze. 

Still getting EDC queries every now and again? When you use Slope’s free sample management solution for sites, it makes it easy to search every granular detail about a sample so that you are better equipped to perform efficient query investigations.

Want to avoid having to enter sample metadata into the EDC altogether? Ask your sponsors to consider adopting Slope as their clinical trial execution platform for managing lab kits, patient samples, and sample metadata. With Slope, sponsors can opt to leverage integrations with EDC, LIMS, and other clinical systems, thereby reducing the burden on sites to perform repetitive data entry and query resolution.

To get started with your free Slope account, click here.