Every aspect of the clinical sector relies on data collection and analysis. For example, we’re increasingly discovering that collecting and interpreting patient satisfaction and behavior data directly impacts patient retention during clinical studies completed by companies such as Clinical Ink. CROs, trial designers, and sponsors can identify and fix potential problems before they occur by listening to patients’ needs and collecting data on patient sentiment. This prevents patients from dropping out of clinical trials. This not only helps the study’s integrity and the physical and mental health of respondents, but it might also save billions in lost income and speed up product development.
Electronic Data Capture (EDC) and Direct Data Capture (DDC) are similar. However, suppose you dig a little deeper. In that case, you’ll notice particular vital distinctions that have significant ramifications for clinical research workflows, data quality, data visibility, and deadlines.
What’s DDC Technology?
A Direct Data Capture (DDC) technology includes capturing clinical study source data directly into an electronic format that has been specifically validated to collect medical data, such as a digital thermometer reading, a Blood Pressure entry in the electronic medical record, a paper form, or an ePRO entry by researcher site staff. The clinical trial data is entered with eSource DDC during the clinical visit, allowing for contemporaneous validations of the data entered, making the data more authentic, correct, and timely.
Collecting Data On the Go
Electronic Data Capture has evolved into an eSource DDC (EDC). Clinical trial data is managed by EDC, a sophisticated technology used by research institutes, sponsors, and CROs. Clinical trial data is first gathered on paper or in the Electronic Medical Record and then transcribed into Electronic Case Report Forms (eCRFs) incorporated within the EDC. Only after the trial data is recorded in the eCRF after the clinical visit does validations or queries for that acquired data arise.
DDC systems based on electronic tablets are ideal for collecting data on the go. Thanks to well-designed workflows and edit checks that guarantee the correct data is obtained throughout the patient visit, devices in homes, ambulatory centers, and remote medical locations can work independently and assist with study execution. As soon as the Internet is available, the data can be transmitted to the website for review by the broader study team.
So, which is better and why?
It would help if you thought about the study phase or therapeutic area while choosing a direct data gathering method for your study. I’ve seen dosing days at Phase 1 sites where the whole place is buzzing with well-drilled activity, with many employees racing from one patient to the next, dutifully carrying out their jobs within very tight time periods. The eSource system adopted must not block data collecting at such busy times.
Clinical research is conducted worldwide and is becoming increasingly digital, but over half of the world’s population remains offline. Traditional paper-based processes and multi-vendor eClinical models might cause difficulties for clinical pharmacology units performing early phase clinical trials. From the monitor through to paper transcription and beyond, a significant amount of time, energy, and cash is spent on processes that contribute little or nothing to the actual collection of data and patient care.
The Direct Data Capture (DDC) solution can speed up data input, improve data quality, and maintain patient safety by allowing site workers to capture source data electronically and sync it straight to an Electronic Data Capture (EDC) without the need for manual transcription.
All of this enables CPUs to detect patient safety signals more quickly, assisting sponsors in obtaining answers to the scientific problems at the heart of early phase trials. As a result, organizations can avoid issues such as sluggish paper sources from production, unplanned events that cause on-site monitoring visits to be delayed, and more.
Regulatory authorities have regularly debated data gathering with industry professionals throughout the years. As a result, the FDA, the EMA, and other regulatory bodies have produced eSource-related white papers and guidances, embracing this type of approach, developing tools, technology, and methodologies that embrace a more direct capture of data.
Article Submitted By Community Writer
