An Electronic Data Capture (EDC) system is a kind of software that stores patient data that is collected during clinical trials. Normally, the data is recorded first on paper and then transferred into the system and saved in an eCRF (electronic case report form). Clinical trials are increasingly using EDC software and are shifting to electronic records instead of paper records. Sites, CROs (contract research organizations), and sponsors have adopted clinical data management software to carry out both complex and simple trials in all research phases. Check out the video below to learn more:
While there are a lot of EDC vendors, there are also organizations that develop their own in-house systems. Most systems have somewhat varying features. EDC software, in any case, is generally meant to streamline the data collection process.
Users of Clinical Data Solutions
Most of the clinical trials nowadays are using electronic data capture software. The primary users of EDC software are:
- Sponsors. The clinical trial sponsor owns the trial. Device, biopharma, and other life sciences firms sponsor the trials and have regulatory authorities (including the FDA) approve their medical innovations before their products are sold. Sponsors may hire various people who use the clinical trial management system in different roles.
Monitors working for the sponsor may virtually visit to the client sites to check data sources and the corresponding datas accuracy in the EDC system. Biostatisticians then help to plan for and analyze the collected data.
EDC system users are responsible for ensuring the trial data is usable and clean. The users may also hand in requests for queries (information) to the sites to resolve and clarify data issues.
- CROs. A contract research organization contracts with the sponsor to facilitate the conduct and planning of a trial. CROs, in certain trials, may do the trial on the sponsors behalf. There are also other trials wherein the CROs may only take analysis, monitoring, and data management roles.
In academia, they are called academic research organizations (AROs), data coordinating centers, or clinical trials units. Their management and coordinating functions are similar to their commercial counterparts functions.
- Sites. A site is the entity that collects and coordinates data from the clinical trial participants usually a clinic or hospital. The site-employed coordinators, which include nurses, will be tasked with inputting data into the studys system. The investigator of the site normally a physician in charge of patient care is tasked to review and electronically sign the data.
The Benefits of Clinical Data Management Software Research organizations are starting to realize the advantages of eClinical solutions over other methods. You can benefit from an EDC system in the following methods:
- Quicker Data Access. An EDC system can save you time on query management and real-time data access. It also saves time at a studys end, enabling faster availability of the data to be analyzed. Moreover, it takes a relatively short amount of time (some take a few hours) to know how to use the EDC system.
- Data Security. The system is hosted online and entering the data is done on an interface that is web-based. Clinical trial software vendors make sure the data is backed-up and protected.
- Organization. An EDC system implementation increases clinical trials efficiency because of its navigation that is user-friendly. You can effortlessly find and filter what you need exactly. You can also store everything in only one location while using paper minimally.
- Accuracy. Data quality can be improved through EDC systems. You can add constraints on a form to prevent illogical or inaccurate values from being entered. A computerized system allows automatic calculations and legible entries for cleaner data.
- Compliance. An EDC system should comply with regulatory requirements. The EDC software must also have in place technical controls to ensure the integrity of the data. To maintain the system, SOPs (standard operating procedures) are vital to ensure that organizational and regulatory policies are met.
- Cost-Effectiveness. An EDC systems costs can be free. It can also be expensive. Prices vary and vendors may also charge for extra services and other fees. While you think that purchasing an EDC system may be a pricey investment, you will actually save money in the long run.
Several factors are considered when implementing clinical trial management software tools. Such factors include:
- Leadership. Implementing EDC needs change management; jobs and processes must change. Management skills, strong leadership, and open and positive attitudes are vital to a successful implementation.
- Planning. The current clinical trial process should be laid out and then revised accordingly using EDC. It also helps prepare for a way to measure the EDCs impact.
- eClinical Trials. Make sure that your EDC system is compatible with an eClinical trial environment. Ensure your system allows eSource data collection, supports data interchange standards, and is poised to fit into electronic applications and processes for an entire clinical trial.
Nowadays, the integration of EDC with other kinds of software in the eClinical area (supply management, randomization, coding, adverse event reporting, submissions, etc.) is increasingly becoming beneficial and feasible. Being able to reliably and quickly import electronic data from imaging data, electronic health reports, and lab reports is also becoming prevalent.The upsurge of electronic data capture software and independent standards for sharing and characterizing data are main enablers toward hastening productivity and decreasing the burden and cost linked to clinical trials.
Kush, R. (2006, June). Electronic Data Capture Pros and Cons. CDISC. Retrieved from https://www.cdisc.org/system/files/all/reference_material/application/pdf/bei26kushsup.pdf
Lopienski, K. (2016, February). The Beginners Guide to an Electronic Data Capture (EDC) System. Forte Research Systems. Retrieved from http://forteresearch.com/news/beginners-guide-electronic-data-capture-edc-system/
OpenClinica. (2016). Fundamental Aspects of Electronic Data Capture. Retrieved from https://www.openclinica.com/electronic_data_capture/