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.[¹] 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.[¹],[²] 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.[³] 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.[³] 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[⁴]:

• Measurements such as blood pressure, weight, body temperature
• Symptoms and disease status as reported by the patient or healthcare professional
• Symptoms or health endpoints collected directly from connected/wearable devices
• Clinical interpretations of a scan or test
• Resolution of a symptom or sign

How does EDC work?

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:

• Graphical user interface - assists the user in intuitively entering data, reviewing reports and trends, and overseeing the progress of the clinical trial and data collection
• Validation component - used for checking the captured data for accuracy and consistency.
• Reporting tool - used to generate reports on captured data and outcomes
• Data de-identification - to improve data security and make patient data less identifiable[²]

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:

• Paper transcription - The basic but least recommended method of utilizing EDC systems is to collect data on paper first and then later transcribe it into the EDC or electronic case report form (eCRF; the electronic file for each individual patient). This method is relatively more time-consuming, prone to human error, and requires additional work. Data could be entered from patient-reported outcomes (PRO), electronic health records (EHR), or other sources that are not directly connected to the EDC.
• Direct data entry - Entering data directly into the EDC from the source (i.e., eSource) is a faster way to capture data electronically. Users can simply open the EDC software on a web browser, log in using their personal credentials, and enter source data directly into the EDC on-site, whereafter it will be available for viewing and sharing with other stakeholders and departments. Surveys for patients wherein they periodically report their symptoms or health status, i.e., ePRO (electronic patient-reported outcomes) could be integrated with the EDC such that ePRO data is copied or entered directly into the EDC as it is filled out by the patient (or their caregiver or healthcare professional in the case of other eCOA methods).
• Automatic transmission - Some electronic data capture systems and setups are integrated with connected devices or wearable devices, which can capture endpoint data automatically and transmit it to the EDC without the need for manual data entry.[⁵] As an example, devices such as wearable heart-rate monitors or glucose monitors could be set up to transmit patient data directly to the EDC at pre-established time intervals.

Who uses EDC in clinical trials?

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.

• Sponsors - Organizations sponsoring clinical trials use EDC to optimize and streamline data collection, both in single trials and to integrate data collected across multiple studies. Team members of the sponsor organization, such as monitors who visit sites and verify and review processes, data, and source documents, may interact with the EDC regularly.
• CROs - CROs, or contract research organizations, are often tasked with certain key operations in conducting trials (or conducting the trial in its entirety), and thus commonly use EDC systems.
• Sites - Sites refer to clinics, research hospitals, or other sites from which on-site clinical trials are conducted. Patient data are measured and collected during study visits, and thus sites frequently interact with the EDC if it is part of the trial workflow. Since many trials involve multiple sites, the EDC is particularly important for data consistency.
• Patients - Patients may also interact with EDC systems, but usually indirectly via ePRO (electronic patient-reported outcome) platforms or surveys that may be connected to the EDC.[¹]

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.[¹],[⁶]

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

Organized, real-time data

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.[³]

Improved efficiency

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.[¹]

Enhanced regulatory compliance

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.[⁷]

Features of EDC and integration with other eClinical solutions

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

• Software integration - Many EDC systems can be integrated seamlessly with other digital/online solutions used in a clinical trial to store all data in a single, coherent access point and simplify global trial management. For instance, many EDCs have built-in eCRFs (electronic case report forms) to simplify or automate the creation of the eCRF for each patient, and might integrate with eConsent such that patients can consent remotely, with their data then automatically added to the EDC and their individual eCRF. Other software that may integrate with EDC include a CTMS (clinical trial management system), eTMF (electronic trial master file), and various eCOA (electronic clinical outcome assessment) methods.[⁵]
• Data entry and export - Users can enter data into the EDC system directly from the source or by transcribing from paper source documents, or data can be transmitted to the EDC automatically. Data can also be inputted or transferred from other sources such as EHR and patient databases, spreadsheets, or connected ePRO instruments. Similarly, EDC generally offers multiple data export formats and has built-in reporting tools to facilitate analyses and provide insights into the trial’s progress.[³],[⁸]
• Query management - The EDC system can act as a portal through which data managers, coordinators, and research monitors can communicate and send queries. Users can generate or send predefined queries assigned for resolution by specific roles.[³]
• eCRF designer - Intuitive and user-friendly eCRF design capabilities enable sponsors and investigators to generate customized eCRFs or build upon pre-made templates. Previously used eCRFs and templates are saved in the system library and can be used in future studies to maintain a standard or streamline eCRF creation. Edit checks can also be enabled in the forms to constrain data entry and ensure consistency and accuracy.[³]
• Data validation - According to 21 CFR Part 11 and Good Clinical Practice (GCP), an EDC system requires validation features such that only the required data is captured. Users can set field validation rules and value ranges to prevent ineligible or incorrectly formatted data from being entered.[⁶],[⁸]
• Data backup - Most EDC systems will include automatic system backups, or otherwise make it easy for users to perform manual backups, which also allows for reversion to prior states and redo actions in case of errors or problems.[8]

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:

• Choose an EDC vendor/provider - Multiple well-established vendors offer pre-built EDC systems, each with different features and functionalities, which we have discussed in our curated list of 12 reputable EDC providers. When choosing a vendor, ensure they have a proven record of success, that the solution will integrate seamlessly with your existing workflow and systems, and that the functionalities offered match your trial’s/organization’s needs.
• Build your own EDC software - Trial sponsors also have the option to build a custom-designed EDC software solution that matches the trial’s or organization’s needs and the complexity of its clinical trials. Benefits to this approach are that it can be built directly into existing workflows or systems, with customized parameters for data collection and endless possibilities for custom interfaces and structural designs. This option may be ideal for tech-savvy organizations who want or need a highly customized solution and full control over the backend of the software.[⁹]

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

• Ensure the system has the ability to capture all of the relevant types of data, from the different sources involved in your trials
• Check that the system meets the specific functionalities you need, such as built-in reporting and analytics, edit checks, audits, customized user permissions, etc.
• Verify compliance with regulatory requirements such as 21 CFR Part 11
• Allow time for the transition to the new workflow, including staff training
• Validate the system and all processes, both centrally and at sites - upon first implementation and periodically during operations
• Take a look through Transcelerate’s eSource Initiative, a great resource with guidelines and free tools on the topic of eSource and electronic data collection

Conclusions

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.