Today, the majority of clinical trials being initiated use electronic data capture software. There are three primary categories of EDC software users: sites, sponsors, and CROs:
- Sites – A site refers to the entity that coordinates and collects data from the clinical trial patients, or subjects; usually a hospital or clinic. Nurses or other designated study “coordinators” employed by the site will typically be tasked with entering data into the study’s EDC system. The site’s Investigator—the physician in charge of the patient’s care and patient’s data–is responsible for reviewing and electronically signing the data.
- Sponsor – The sponsor of a clinical trial is the organization that “owns” the trial. Biopharma, device, and other life sciences companies must sponsor clinical trials in order to get their medical innovations approved by regulatory authorities (like the FDA) before they can go to market with their product. Sponsors may employ a variety of people who use the EDC system in various roles. Monitors working on behalf of the sponsor may visit the client sites to review data source documents and verify the accuracy of corresponding data in the EDC system (with EDC software this “visit” is often virtual). Biostatisticians help plan for and analyze data collected. Typically heavy users of EDC software, data managers have the responsibility is to ensure the trial data is clean and usable. Among other tasks, they may submit requests for information (called “queries”) to the sites 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 trials, the CROs may effectively operate the trial on behalf of the sponsor. In other trials, they will take on only some of the key roles (data management, monitoring, analysis). In this regard, CROs may have many of the same types of EDC system users as sponsors. In academia, CROs are often called AROs (Academic Research Organizations), Clinical Trials Units, or Data Coordinating Centers. Their coordinating and management functions are much the same as their commercial counterparts.
In addition to the above types of EDC users, study patients may also contribute data to the EDC system, either directly through a specialized role in the software, or via a separate device and/or application that transmits data to the EDC system. The practice of patients entering data is called ePRO (electronic patient reported outcomes).