Making the Switch: Reviewing Data In an EDC

Part 5 – How to Review Data Within an Electronic Data Capture  

Welcome to Part 5 of our series, “Making the Switch: From Paper to EDC.” In this final installment, we will explore the advantages of data review within an electronic data capture (EDC) system.

If you are involved in clinical trials or lab research, you might have come across the term Electronic Data Capture (EDC). EDC systems have revolutionized how data is managed, reviewed, and analyzed, replacing the traditional paper-based approach. In this blog, we’ll explore the advantages of data review within an EDC, how it differs from paper-based workflows, and some tips to ease the transition. 

What Are the Differences Between Paper and EDC Data Reviews? 

The primary distinction between data review in an electronic data capture (EDC) system and the traditional paper-based approach lies in their workflows and tools. They include:

• Collaboration
• Workflow and Document Management
• Query Reports and Error Tracking 
• Audit Trails and Data Integrity

Collaboration

With paper-based data review, everyone must be physically present at the same site or rely on the postal service to exchange documents. On the other hand, EDC systems like Prelude offer a centralized platform accessible to authorized users from anywhere via the internet. Scanning and saving to a document-sharing platform is an option with paper-based data review. However, the work involved in scanning volumes of paper and managing signatures is inefficient and laborious. Electronic data entry, remote access, and the built-in review workflow offered by an EDC allow seamless collaboration among site staff, monitors, and quality assurance, regardless of their physical locations. 

Workflow and Document Management

In a paper-based study, data review can take weeks due to the need to get through stacks of papers or an entire patient’s file. Additionally, forms may need to “travel” around a clinic for review, which can add time to the review process. An EDC, on the other hand, allows review in parallel. It efficiently manages the data review workflow – moving documents through each stage (at a minimum, from the “in work” to “reviewed” to “finalized” review stages) as reviewers access and electronically sign forms when they become available and move from one stage to the next (e.g., an in-work form can be reviewed and finalized within a day). This feature significantly accelerates the review process and eliminates delays. 

Query Reports and Error Tracking

In a paper-based workflow, compiling a query report involves manual efforts to review data and generate findings so that any errors and issues can be documented and addressed. In contrast, EDC systems simplify this process with built-in query and comment functionality. Within an EDC, queries and comments are identified at the source (i.e., the field with the datum in question), enabling auditors/reviewers to track errors and investigators to verify or correct errors in the data efficiently. Additionally, generated summaries that aggregate the queries and comments make query report creation easy and fast. 

Audit Trails and Data Integrity

With paper-based data review, maintaining a change in custody log requires signing off documents and tracking their whereabouts. EDC systems automatically maintain audit trails, providing a secure and reliable electronic history of data changes, additions, and reviews. This makes monitoring data and following its journey easier to ensure data integrity. 

What Are the Similarities Between Paper and EDC Data Reviews? 

Although an electronic data capture (EDC) system streamlines data review and management, some aspects remain similar to the paper-based approach: 

• Reviewers’ Involvement: The same study roles are needed to review collected data regardless of where data is collected. 
• Protocol Compliance: Paper-based and EDC data entry workflows are typically designed and built to ensure adherence to the study protocol. However, there is a clear advantage when using an EDC. Studies built with an EDC allow for edit checks configured per protocol specifications. These edit checks give site staff real-time feedback as they enter data (i.e., ideally, missing or erroneous data points are addressed at the time of entry), and monitors can quickly spot deviations during a review. 

We Are New to This! Is There Anything to Make It Easier? 

The initial transition might seem daunting for those new to reviewing data within electronic data capture (EDC) systems. However, adopting some best practices can make the review process smoother: 

• Leverage Queries and Comments: Take advantage of query and commenting features in the EDC system, like Prelude. They help facilitate communication among reviewers and make it easier to address any discrepancies in the data. 
• Utilize Summaries: Summaries aggregate form and query statuses, accelerating the data review progress and minimizing the chances of overlooking critical issues. 
• Embrace Technology: While transitioning to an EDC might be challenging for some, platforms like Prelude EDC are designed to be user-friendly, making the learning curve less steep. As you gain experience, how your team uses EDC features and tools can be improved to address your team’s needs. 

Data review within an electronic data capture (EDC) system offers numerous advantages over traditional paper-based workflows. The centralized nature, real-time collaboration, and automated tracking significantly streamline the review process. Although transitioning to EDC may require some adjustment, its benefits to data management and integrity make it well worth the effort. With time and experience, data review within an EDC system like Prelude makes your research journey smoother.  

“In today’s workplace, remote work is so common that having everyone onsite at all times is less common.  Therefore, one of the greatest assets of using an EDC rather than paper is the fact that all data review can take place from anywhere as long as you have internet access and the appropriate role in the study.”

Ann-Marie Kiser, Director of Compliance at Prelude