Direct Data Capture (DDC) and Electronic Data Capture (EDC) sound the same. But understanding a little deeper, there are fundamental distinctions with crucial implications for clinical research workflows, quality of data, data visibility, and timelines.
eSource Direct Data Capture (DDC) is any technology that allows capturing clinical study source data, whether it’s a digital thermometer reading, a Blood Pressure (BP) entry in the electronic medical record (EMR), a paper form, or an ePRO entry by researcher site staff at the point of care, directly into an electronic form that has been specifically validated to capture clinical data. With eSource DDC, the clinical trial data is entered during the clinical visit, allowing validations for the data entered to occur at the same time so that the data is also more legit, accurate, and timely.
An eSource DDC is an evolution of Electronic Data Capture (EDC). EDC is the modern technology used by research institutions, sponsors, and CROs to manage clinical trial data. With EDC, data from clinical trials are initially captured on paper or in the Electronic Medical Record and then transcribed later into Electronic Case Report Forms (eCRFs) built within the EDC. Validations or queries for that collected data arise only when that trial data is entered in the eCRF after the clinical visit.
SyMetric Clinical Trial Platform is built for the cloud era with modular, integrated tools that are designed to provide flexibility to tailor to your study requirements, including Adaptive Trials, Umbrella Trials, Basket Studies, and Virtual Clinical Trials. It is designed and built to be an end-to-end platform for Clinical Trials that can be used as an eSource, where the web-based EDC can be carried out on a laptop or a tablet, and data is entered directly into this system.
What if an existing medical record needs to be incorporated?
In any trial, at a patient’s initial visit, historical information such as medical history, laboratory reports, or medication data will likely need to be transferred into the study record. It’s no different when you implement a DDC system. Pre-existing information in the paper or electronic medical record, the PRO record, or elsewhere may need to be transcribed into the DDC tool – the same way it would need to be transcribed into an EDC system.
SyMetric innovative Electronic Data Capture (EDC) tool with its agile methodologies allows users to set up and configure study databases in no time. Users can also design Case Report Forms (CRFs) with programmed edit checks and collect high-quality, accurate clinical data along with extracting submission-ready standardized datasets from an easy-to-use web-based graphical user interface. If clinicians make a mistake, forget to report something, or enter a result outside of the acceptable range, the platform automatically alerts the defined user. It is possible to download any mid-study changes, ensuring that the recorded data is always adhering to the latest version of the protocol and makes sure the study is fully compliant.