Electronic Data Capture (EDC) is admittedly a fairly generic sounding term, but in the clinical trials field it actually means something fairly specific: using systems to collect clinical trial data in electronic form as opposed to paper form.
At BBMCT, we are immersed in EDC all day, every day. However it’s important to recognize that many participants in the field of clinical trials are still just getting their feet wet with EDC. The system allows for the secure and accurate collection and cleaning of the data from each study. This comprehensive tool provides functionality in the areas of study design, data entry, data clean-up, coding of terms, data changes, reporting, real-time web access, audit trail, and export of the clinical data for analysis purposes.
- Custom Designed Data Entry Screens
- Designed to mimic case report forms
- Simple, easy-to-use screens
- Case Report Form (CRF) Tracking
- Status progression from Entry to Locked
- Integration to enhance visit and form tracking
- Robust Edit Checks
- Customized edit checks find and flag incorrect data upon entry
- Fields dynamically enabled or disabled based on design
- Data Query Generation and Tracking
- Local Lab Normal Range Tool
- Targeted Source Data Verification
- Medical Coding
- Flexible, Useful and Customizable Reports
- Detailed status reports
- Patient profiles
- Ad-hoc report builder
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).