Electronic Data Capture (EDC) Systems for Clinical Trials

What does EDC stand for in clinical trials?

EDC stands for electronic data capture. Electronic data capture describes systems that are used to collect data electronically in clinical trials.[

] They help streamline data collection processes, reducing errors, inconsistencies, and inconveniences associated with paper-based data collection. 

What is an electronic data capture system and what is it used for?

Electronic data capture systems are a way of digitizing traditional paper-based data collection processes, helping trial sponsors organize and manage data more efficiently and accurately. Most EDC programs are web-based, simply requiring access to the internet, enabling various stakeholders involved in a trial to access unified data from separate locations and in real-time.[

] EDC systems can be a great tool for enhancing data quality in both simple and complex clinical trials.

Researchers can capture source data directly into the system (so-called “eSource” data), or first record it on paper and then transcribe it to the system.[

] In clinical trials, EDC increases data accuracy and significantly decreases the time spent collecting, managing, and storing data. EDC systems are equipped with a graphical and user-friendly interface, a validation component to validate captured patient data, and a reporting tool to assist with assessments and analyses.[

] Together, these components create a powerful software tool for capturing and organizing clinical trial data in a unified and readily accessible format. Common types of data that may be captured by or written into an EDC system include[

In order to understand how an EDC system works, we will first review the basic components of an EDC and how they facilitate data collection in clinical trials. Generally, a basic EDC setup includes the following components:

In terms of how data is entered into the EDC, there are a few methods that researchers and sponsors can use to capture data in electronic format:

Electronic data capture systems are used by various organizations involved in conducting and/or sponsoring clinical trials. The web-based nature of EDC systems allows them to be accessed by multiple users simultaneously and from different locations.

Benefits: How EDC is revolutionizing clinical trial data management

Electronic data capture streamlines clinical trials by simplifying data collection and data management operations, cutting down on data entry tasks and allowing sites and sponsors to access real-time data centralized in a web-based system. EDC ensures high-quality data through validity checks and verification features that ensure that data is complete and formatted as required.[

Other advantages of using electronic data capture in clinical trials include:

The EDC system can be set up to place constraints on data entry fields, which prevents errors and ensures consistency amongst data entered from separate sites.

The user-friendly navigational interface and data search and filtering features allow various stakeholders to access unified data stored in a secured, centralized location in real-time. This reduces query management time and makes data more readily available for analysis and reporting. Different permissions can be set to ensure that only specific personnel can access specific data, thus, further enhancing security.[

EDC systems reduce the time required from data collection to database lock, and can automatically identify data discrepancies and resolve data issues. Overall, EDC improves efficiency of the data management component of trials and has the potential to speed up time to completion. When combined with remote data collection methods, EDC can reduce the number of on-site visits required of patients, and automated data collection workflows (for example through connected devices) eliminate the need for manual data entry entirely.[

EDC systems should be fully compliant with regulatory requirements, such as Title 21 CFR Part 11, which provides acceptance criteria for electronic records and electronic signatures. The direct integration of regulatory standards in EDC systems greatly facilitates compliance.[

Features of EDC and integration with other eClinical solutions

Some common features of a typical electronic data capture system include:

Best practices for implementing an EDC system  

Now that we have clarified the benefits EDC can offer to clinical trial operations, let’s discuss two main ways by which sponsors/CROs/sites can go about implementing EDC into their workflows:

Whether selecting a third-party EDC vendor or creating your own software, keep the following considerations in mind when integrating EDC into your workflow:

Electronic data capture (EDC) systems allow sponsors, CROs, and sites to enter coherent, validated data in a secure, centralized, cloud-based location, from where it can be readily accessed all data from a single point, and share it with all stakeholders. Simply put, it simplifies data collection and management, minimizes data entry errors, and safeguards regulatory compliance in clinical trials. EDC represents a cost-effective tool to help streamline your trials and hasten time to approval and marketing.

Electronic Data Capture (EDC) Systems for Clinical Trials

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