Collecting and transcribing data is perhaps one of the most time-consuming stages of any clinical trial. Traditional practice dictated using case report forms (CRFs) in paper form and entering data into the system.
Thanks to technology, modern research is currently done with increased speed and data entry accuracy using electronic data capture or EDC. But what is it? And what makes it valuable to a clinical trial? What features must you be looking for in an EDC? Read on to find out.
What Is Electronic Data Capture?
An EDC serves as a digital platform, often software, replacing the old method of using case report forms in paper format. A CRF is a document used by researchers to record information about their clients or patients. As clinical trials can discuss vast medical issues, including studying new diseases and symptoms, developing new drugs, and managing health conditions, CRFs for each patient can run several pages.
With this electronic method, research data is entered into a web-based platform. While clinical research organizations may still use paper-based CRF, most of these crucial data-gathering tool is automated. As such, research teams can either create forms independently or use easy CRF designs as a template.
Besides data collection, users can utilize this technology for validating data and determining research status with their inherent features.
Which Features Should You Look For In An EDC?
The good thing about EDC software is that clinical research organizations can customize it based on their needs. While medical trials cover a wide range of issues, there are specific system properties that you must check before choosing the ideal solution.
- eCRF designer or templates: As mentioned, research teams can either create a data gathering form from scratch or pick a template from the database and tweak some of the fields to increase compatibility with the nature of the research.
When creating a form from scratch, users must ensure data accuracy by assigning mandatory fields and identifying invalid or incomplete entries. Complete and error-free data is crucial in research teams so that precise results and analysis can be culled from the activity.
- Seamless integration: An EDC solution may come with all the bells and whistles, but this amounts to nothing if you can’t integrate it with the systems and technologies in your research lab. Similarly, the software should facilitate collaboration between and among the research teams or medical consultants if necessary.
- Data export and attachments: There may be instances when a specific patient’s form needs to be extracted for further examination. This holds for breakthrough studies of new medications, for example, COVID-19 oral pills. An eCRF may require attachments, such as medical literature, to serve as a reference in some cases. An EDC must make these functions stress-free for researchers.
- User-friendliness: A clean and streamlined user interface is primordial in an EDC. Researchers will spend less time learning about the system and even less time encoding correct data entries. Hence, this feature not only saves you time but also reduces the risk of human error.
- Sensible data entry procedures: Apart from being user-friendly, a research management solution must come with must-haves in collecting accurate data. These include automatic or manual query management, mandatory field requirements, and incomplete or invalid data identification.
- Data metrics: In all clinical trials, the process of arriving at analysis and conclusion is purely human activity. A system that has built-in metrics helps identify the progress of the research. This crucial feature is necessary for research as well to formulate accurate data interpretation.
- Security: Clinical trials are covered by applicable regulatory requirements, including data integrity, privacy, and protection. So, the software solution must have built-in mechanisms to ensure these are followed and complied with, alongside organizational procedures. Making EDC and research data accessible online shouldn’t raise a red flag.
- Data reusability: Research organizations must ensure that their initial efforts won’t be put to waste. There are too many research questions that need to be answered and explored. That being said, your EDC should facilitate future use of research data.
5 Benefits Of Using EDC System
There are several reasons why research organizations must use electronic data capture in their clinical trials. With this electronic data management solution, entities can experience the following advantages:
- Cost-efficiency: While installing the system entails a significant investment, organizations can save on costs down the road.
- Increased data accessibility: An EDC system allows authorized users to access and update research data whether they’re inside or outside the laboratory.
- Reliable data: This digital solution has built-in data validation processes, ensuring data integrity.
- Enhanced operational efficiency: EDC streamlines the processes involved in data entry and management through its built-in features and customization.
- Compliance: Because of the nature of data needed in a clinical trial, researchers are mandated to establish safeguards that protect data and preserve its accuracy.
An electronic data capture system is critical in managing clinical research data. Besides significantly reducing research time and costs, a reliable EDC system provides multiple benefits. These include complying with regulatory laws, enhancing data integrity, and ultimately improving study procedures without compromising data accuracy and integrity.