EDC Clinical Trials

EDC Clinical Trials Complete Guide

Electronic Data Capture (EDC Clinical Trials) is admittedly a fairly generic-sounding term, but in the field of clinical trials it actually means something quite specific: the use of systems to collect clinical trial data in electronic form, as opposed to paper.

At Vial, we are immersed in EDC all day, every day. However, it is important to note that many participants in the field of clinical trials are still just dipping their toes in EDC. Here’s a basic introduction to the basics of EDC.

An electronic data collection (EDC) system is a computer system designed to collect clinical data in an electronic format for use primarily in human clinical trials. It replaces traditional paper-based data collection methodology to streamline data collection and accelerate time to market for drugs and medical devices. Also EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CROs).

EDC systems typically provide:

  • A graphical user interface component for data entry
  • Authentication component for checking user data
  • Reporting tool for analyzing collected data

EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device, and biotechnology industries, in all aspects of clinical research[2], but are particularly beneficial for late-stage studies (Phase III-IV) and pharmacovigilance, and after market safety supervision.

What is EDC Clinical Trials system?

Modern electronic data capture software is usually useweb and uses a thin client. Web-based means that the software runs entirely on a web server (think Google.com), and thin client means that the only tool you need is a regular web browser (without any cumbersome plug-ins) connected to the Internet to access the EDC Clinical Trials software and use it (again I mean Google.com).

Data from clinical trials can be captured electronically at the source (so-called e-source) or in paper form and later transcribed into the EDC system.

What is the use of electronic data collection?

Currently, most clinical trials initiate use electronic data capture software. There are three primary categories of EDC software users: Sites, Sponsors, and CROs:

Sites

Site means an entity that coordinates and collects data from patients or clinical trial subjects; usually a hospital or clinic. Nurses study “coordinators” employed on site will usually task with entering data into the study’s EDC system. The on-site investigator – the physician responsible for the patient’s care and data – is responsible for reviewing and electronically signing the data.

Sponsor

The clinical trial sponsor is the organization that “owns” the trial. Biopharma, device and other life sciences companies must sponsor clinical trials to get their medical innovations approve by regulatory bodies (such as the FDA) before they can bring their product to market.

Sponsors may employ different people who use the EDC system in different roles. Inspectors working on behalf of the sponsor may visit client sites to verify source data, review data source documents, and also verify the correctness of the corresponding data in the EDC system (with EDC software, this “visit” is often virtual).

Biostatisticians help plan and analyze collected data. Typically heavy users of EDC Clinical Trials software, the data controller has an obligation to ensure that test data is clean and usable. Among other tasks, they may submit requests for information (called “queries”) to the Site to clarify and resolve data issues.

CRO

A CRO or contract research organization is an entity that contracts with sponsors to facilitate the planning and conduct of a clinical trial. In some studies, CROs may actually conduct evaluations on behalf of the sponsor. Also in further trials, they will only take on some key roles (data management, monitoring, analysis).

Moreover in this regard, CROs may have many of the same types of EDC Clinical Trials system users as sponsors. In academia, CROs are often called AROs (Academic Research Organizations), clinical trial units, or data coordinating centers. Their coordination and management functions are almost the same as their commercial counterparts.

In addition to the above types of EDC users, study patients can also add data to the EDC Clinical Trials system, either directly through a specialized role in the software or through a separate device and/or application that transfers data to the EDC system. The practice of having patients enter data is call ePRO (electronic patient report outcomes).

Why use electronic data collection software?

EDC Software

Most new clinical trials today use electronic data capture software. Some of the common motivations for using EDC Clinical Trials include:

Cleaner Data

EDC software is particularly good at enforcing certain aspects of data quality. Editing and source data validation checks program into the software can ensure that the data meets certain require formats, ranges, etc., before the data is accept into the test database.

More efficient processes

EDC Clinical Trials software can help guide the site through a series of study events, requesting only the data needed for a specific patient’s circumstances at a specific time. It enables the process of clarifying data inconsistencies using tools to identify and resolve site data issues and can help reduce the number of in-person site visits required during the trial period.

Faster Data Access

Web-based EDC systems can provide near-real-time access to clinical trial data. This insight enables faster decision-making and can support adaptive trial designs.

Each of the above reasons for using EDCs addresses issues of efficiency and productivity, and thus can also reduce the cost of clinical trials.

What is the difference between EDC and eCRF?

Electronic Data Capture

There is a difference between EDC and eCRF. Electronic Data Collection, EDC, is software usees to collect data from clinical trials then an electronic case report form, or eCRF, is a digital (usually web) questionnaire for collecting data about a study participant. eCRFs live inside the EDC, enabling clinical data managers and other clinical research stakeholders to collect better data faster.

What is the difference between CDMS and CTMS?

CDMS and CTMS are different. A CDMS, or Clinical Data Management System, is a solution use by pharmaceutical and biotechnology companies to manage clinical data during clinical trials. An EDC, or electronic data collection system, is similar to a CDMS in that both use to collect, store, and analyze participant data.

A CTMS or clinical trial management system is use for operational efficiency during a clinical trial. For example, document storage for clinical trial project management, tracking deadlines and milestones, and centralized invoicing processes.

Trends in EDC

In the 1990s, electronic data capture was referr to as “remote data capture” (RDC). Compared to today’s technology, these systems were quite archaic, often built on a client-server architecture involving a thick, sometimes specialize device, as opposed to a regular PC. These systems were essentially data “silos” that did not easily exchange their data with other systems.

Nowadays, the integration of EDC Clinical Trials software with other types of software in the eClinical spectrum (randomization, supply management, adverse event reporting, coding, submission, etc.) is increasingly feasible and beneficial. The ability to quickly and reliably import electronic data from other sources (such as laboratory reports, image data sources, and electronic health records) is also becoming commonplace.

The rise of open source EDC Clinical Trials software and independent data characterization and sharing standards (such as CDISC) are key enablers to accelerate productivity and reduce the costs and burdens associated with clinical trials.

More reads:-

Preclinical Oncology CRO Market Risk and Opportunity Assessment, and Forecast to 2030

What is a Contract Research Organization?

What Is Ophthalmology CRO?

Ophthalmology Clinical Trials CROs By Vial

Gastroenterology CRO Is The Best For Hospitality

What Procedures Do Gastroenterology Clinical Trials Follow?

 

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