If you’re new to electronic data capture (EDC) systems, hopefully after reading this you’ll have a basic understanding of the EDC system and its role in clinical trials.
What is an EDC system?
To put it simply, an EDC system is software that stores patient data collected in clinical trials. Data is typically first recorded on paper, and is then transcribed into the system and saved in an electronic case report form (eCRF). More and more clinical trials are making the move to EDC software and replacing paper records with electronic records. Sponsors, contract research organizations (CROs), and sites have adopted EDC systems to carry out both simple and complex trials in all phases of research. While there are many EDC vendors, some organizations build their own system in-house. Most EDC systems offer slightly different features, but in general EDC software is designed to streamline data collection.
What are the benefits of an EDC system?
Many research organizations are realizing the advantages of EDC over other methods and are leveraging new technologies to support clinical trials. An EDC system can help you achieve success in the following ways:
Quicker Access to Data. An EDC system can save a significant amount of time with real-time access to data and less time spent on query management. This also saves time at the end of a study allowing quicker availability of the data for analysis. While it can take substantial time to initially learn how to use a specific system, some are so intuitive that only a few hours of training is required.
Data Security. An EDC system is hosted online with data entry completed on a web-based interface. Given the nature of the data collected in an EDC system, software vendors make sure the data is protected and backed up. Because each user account has designated permissions, most actions can only be carried out by certain roles.
Accuracy. EDC systems improve data quality. There are options to add constraints on a form that prevent inaccurate or illogical values from being entered. Using a computerized system enables legible entries and automatic calculations for cleaner data.
Organization. The use of an EDC system increases efficiency of clinical trials due to its user-friendly navigation. Search options allow you to easily find and filter exactly what you need, and store everything in one location with greater visibility while using less paper.
Cost-Effectiveness. Financially speaking, the cost of an EDC system ranges from free to expensive. Pricing varies, and some vendors charge for additional service and other fees. Purchasing an EDC system can seem like a large investment, but it should save money in the long run.
Compliance. An EDC must be compliant with regulatory requirements. A big one is 21 CFR Part 11. The software should have the technical controls in place to ensure data integrity. To properly maintain an EDC system, standard operating procedures (SOPs) are essential to ensuring that regulatory and organizational policies are met.
What are common features of an EDC system?
Most software vendors are continually developing new enhancements to keep up with changes in the industry. While the bells and whistles vary from system to system, there is some functionality that you’ll find in just about every EDC solution.
eCRF Designer. When creating eCRFs, there are design options to choose from that are meant to imitate paper forms. Forms are saved in a library and can often be used across multiple protocols. This eliminates the need to recreate commonly used forms and promotes data standards. When building forms, edit checks can be programmed to help prevent invalid data from being entered. This can ensure that the values entered meet certain requirements.
Data Entry. After a protocol is set up in the system, the data that was collected is entered into the appropriate forms.
Query Management. An EDC system provides streamlined communication between monitors, data managers and coordinators. Most systems have auto-generated queries and the ability to manually add queries. All queries need to be responded to and resolved by different roles before the data can be locked.
Data Export. Once you’re ready to pull the data out of the system, there are easily accessible exports to extract patient data. Some systems have built-in metrics reporting that offer insights into the progress of a study.
Explore the features that make Forte EDC easy. Download the overview PDF here.
Electronic data capture systems have become a very popular tool to use in managing data in clinical trials. An EDC system can help increase efficiency, ensure data quality, reduce the time and cost of clinical trials, and help meet regulatory compliance. If you’re looking for an EDC system, there are many things you’ll need to consider – don’t forget to ask these questions.
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Author’s note: This article was originally published on 1/17/14.