Introducing

What is an Electronic Data Capture EDC System?

The world's most valuable resource currently is data! For clinics, knowing how to manage data effectively is key. If you are in the field of clinical trials, the chances are you heard of

Electronic Data Capture or EDC.

But if you didn’t, or if you are just getting started, let us introduce you to EDC systems. An EDC is a core tool for medical, clinical, pharmaceutical, biotech, and academic research. It helps collect, clean, store, and analyze data to produce an accurate one.

Researchers working on edc

After reading this article, you will understand EDC system fundamentals fairly. Let’s begin with an overview of the EDC system

What does an Electronic Data Capture mean?

In clinical trials, data is captured electronically from patients or subjects using an Electronic Data Capture system, abbreviated an EDC system. An EDC is a software application for collecting, cleaning, processing, transferring, and storing clinical study data. These systems can be web-based or on-premise applications.

Sometimes an EDC is referred to as an eCRF (electronic Case Report Form); however, there are differences between the two that we will explain later in this article.

History of EDC systems

Traditionally, clinical trials were recorded in paper form. Where later, the data is transcribed and saved into an eCRF. However, the electronic solution appeared due to researchers' efforts to speed up this process. The EDC systems emerged to be used for data collection and management replacing the traditional paper-based data capture process.

There where EDC software made its move to become a reliable and quick tool for capturing and processing data. Organizations like medical centers, pharmaceutical industries, clinical researchers, etc., started to adopt the digital platform for clinical studies. EDCs are helping labs to undertake trials from simple to complex and in all research phases.

Back in the 90s, EDC systems were called Remote Data Capture (RDC). The RDC used old technologies, and they were built on a client-server architecture. An RDC showed difficulty in sharing data with other systems.

Today, EDC systems use advanced technologies to streamline clinical trial data. Therefore, they are broadly used in labs in a regulated environment. Standards of sharing data helped to increase EDC systems' utility.

Who are the EDC system users?

Any life science organization can use an EDC. Below are the main user categories of electronic data capture systems:

Sponsors:

To get their medical products approved by regulatory authorities, for instance, Food and Drugs Administration (FDA), organizations must perform clinical trials. The organization that funds the clinical trial for that purpose it’s called a Sponsor. The company Sponsor recruits people that use EDC software. Also, they often request queries to Sites – that we will see next

Sites:

A site is an organization (clinic, hospital, medical center…) that makes clinical trials and collects data from subjects or patients.

Subjects/Patients:

They are the study patients that enter the data. In this regard, they may use an EDC system directly or a different application that transmits data into an EDC.

Contract Research Organizations (CRO):

A CRO is a facility that contracts with a Sponsor to coordinate and facilitate the clinical trial. They are responsible for conducting data monitoring, analysis, and management. They can even go further and operate all the trials on the side of the Sponsor. CROs can be commercial or academic, and the latter is also labeled Academic Research Organization or an ARO.

Advantages of an EDC system

Due to their many benefits, most clinical trials use EDC software. Since much of the earlier burden of study design and setup has been made easy and accessible through technologies. EDC systems manage to handle efficiency and productivity issues and reduce clinical trial costs. Let’s mention the main advantages of EDCs:

Clean and quality data:

A significant benefit of EDC is having clean, accurate, and high-quality data before transmitting it into a trial database. How so? It’s by offering several options of data quality such as:

  • Add constraints for preventing inaccurate values.
  • Source data verification and program checks according to the requirements.
  • Add validation and dependencies to forms.
  • Flag out errors or inaccurate data according to the pre-determined values.

For example, suppose we are collecting data about blood pressure. In that case, we can add a constraint for adding only numbers for the BP values to prevent entering any other values like characters. We can edit checks by programming the required range. And in case of errors in the results, we receive a flag indicating the data entry error.

Real-time Accessibility

They are gone the days of hassling for writing and shipping paper forms. Now, EDC systems give real-time access to clinical trial data. Saving time is very important for Sites, and EDC solutions manage not only to save a significant amount of time but also to provide Sites with quick and easy access to data from any computer.

The accessibility in real-time advantage is quite important. Since it supports the adaptive trial design, fasters decision-making, saves time for query management, and speeds up data availability and analysis.

One of the most accessible EDC software is Di-EDC which provides an intuitive interface and a safe environment for data capturing.

Efficiency

EDC software increases the process efficiency of a clinical trial. Since using it allows you to organize data, navigate through it quickly, and search and filter the requested data without forgetting to mention the user-friendly interface of an EDC that helps in data entering and managing.

Data security

Given the sensitivity of data collected in EDC software, besides the fact that EDC systems are available as a cloud-based application, allowing users to access them from anywhere across the world to facilitate collaboration, data protection, and backup is highly fundamental. Therefore, EDC vendors pay significant attention to secure data.

One of the ways to guarantee data authenticity and security is the Access Control Management. Where each user account is set to pre-determined permissions, and each role can carry only its pre-designed actions. This method also helps in controlling data traceability.

For instance, Di-EDC offers complete control over permissions and access rights. It enables you to assign the “sensitive data” tag for more protection.

Cost-effectiveness

Comparing an EDC to traditional methods from a financial stand, an EDC system is a wise investment. Well, at the beginning may seem like a big investment, but in the long term, it is a great decision to reduce costs along with its other benefits.

The greatest thing about EDC costs is that once the clinical trial is done, its data can be stored in databases and re-used repeatedly. Researchers find a utility in the saved data by replicating it or combining it to come up with new tests and analyses. In such cases, EDCs will spare you from queries all over again.

Compliance

Standard operating procedures (SOPs) are vital for EDCs, so they must comply with them. As a matter of fact, due to the strict increase in clinical research regulations, compliance is the primary reason for researchers to switch to EDC solutions.

EDC software compliance allows you to control audit trials, data encryption, access rights, on-demand reporting, and automatic backup.

Features of an EDC system

The Healthcare industry is constantly evolving and changing, and so are the electronic data capture systems. EDCs are continually improving and enhancing their features to meet the industry requirements. Besides, they offer more powerful features to stand out from the competition. However, there are common and standard features that you can find in any EDC. Here are some of them:

  • eCRF: EDC provides options to design electronic case report forms. Forms can be saved as templates in the system library to be used again.
  • Data entry: It has an entry to the collected data in forms with real-time validation.
  • Query management: An EDC enables you to add queries, whether manually or automatically. And to manage them by communicating, responding, or resolving queries by different roles such as coordinators, monitors, or managers.
  • Data exporting: Generating reports or extracting patients’ data is an essential exporting feature in any EDC.
  • Access control: A multi-level user access control enables the tracking of each user via user ID, IP address, date, time, and access type.

EDC software components

A typical EDC system has the following components:

  • Data entry graphical UI: This component is used for data entry
  • Data validation: This is used to check the user data for correctness
  • Reporting tool: It offers analysis and insights of the collected data and study.

The difference between EDC, eCRF, CDMS, and CTMS

As we mentioned before, sometimes the terms EDC and eCRF are used interchangeably. However, there are slight differences between an EDC, an eCRF, a CDMS, and a CTMS. Let’s discover them:

  • eCRF or electronic case report forms is actually a part that lives inside an EDC software. While an EDC is for managing clinical trials, an eCRF is the first step dedicated to collecting data via digital questionnaires.
  • CDMS or clinical data management system is similar to an EDC. They are both used for collecting, storing, and analyzing clinical trials. A CDMS can be a part of a CTMS.
  • CTMS or clinical trial management system is used for operational efficiency. It helps Sites in clinical data validation, patients’ information registering, deadline tracking, and other activities.

Data processing in an EDC system

The following steps are the main steps of any EDC to process data:

  • Data collection: Usually, an EDC provides a web-based form where users can enter clinical data in the corresponding fields.
  • Data cleaning:At this phase, the data is refined by resolving any existing discrepancies.
  • Data exporting and analyzing: The cleaned data is then exported to statistical program tools such as SAS or SPSS.

EDC’s data types

There are different types of data collected into EDC systems. The types depend on the therapeutic area of the clinical trial. However, the main categories of data are the following:

  • Background information: age, medical history, medical conditions, vital signs, etc.
  • Research data: they are the information specific to the study.
  • Additional information: such as bloodwork or CT scans.

How much does an EDC software cost?

Financially speaking, the EDC software exists in three types: open source, commercial, and in-house developed. EDC pricing depends on advanced features and the quality level of the system. Commercial EDC software prices range from $10 to $5000 per month.

For an excellent price and powerful features, check our Di-EDC software.

Final thoughts

To conclude, we can say EDC systems are a top-rated tool for managing clinical trial data. They become necessary for any lab aiming to increase efficiency, guarantee data quality, or reduce time and costs. If your lab does not use an EDC yet, this is the time to start using it.