QUALITY CONTROL IN CLINICAL DATA MANAGEMENT ON THE BASIS OF EDC

Gathering high-quality, reliable, and statistically sound data is the goal for every clinical trial, and effective data management is essential to ensuring accurate data collection, entry, reports, and validation. As a critical phase of the clinical research process, it’s important to establish and maintain organization-wide standards for data management to ensure consistency across all individuals and teams involved.

Miscommunication and ambiguity in the data management process can lead to costly mistakes that waste staff time and resources, ultimately putting your organization and clinical trial at risk. These five fundamental elements of quality clinical data management can both improve your organization’s data management standards and help you implement them across necessary stages of the clinical trial process.

The advent of digital technologies has revolutionized clinical trials. The electronic data collection system (EDC system) can remarkably improve data quality.  To collect high-quality data, the EDC system must be configured properly .With electronic data capture systems (EDC), the process of collecting and analyzing user data has been streamlined, leading to a significant increase in time to market for new drugs and medical devices. This dynamic has not only removed the various complexities associated with storing data on paper, but has also made the data far more accessible, and easier to analyze.

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Swapping paper for digital

In these unprecedented times, laboratories face tough decisions regarding the continuation of their research. One such decision is to either participate in technological and digital advances or be left behind. Remote work has proven to have its own set of challenges for some laboratories more than others. This is attributed to the fact that many laboratories still use paper as the main method of recording their research. Even without the current pandemic, this method created significant setbacks, as scientists would have to search through a number of paper notebooks in order to find the relevant previous experiments/data needed. Not only is this method impractical, as it requires a scientist to be on-site to access research, but it is also both error-ridden and time-consuming. The electronic Data Capture eliminates the need for the manual transcription of an experiment. These features allow scientists to continue research from anywhere with internet connection.

While developing standard procedures that align with industry best practices is critical to improving clinical data collection and quality at your research organization, efficiency in the clinical trial process is often only as good as the systems you choose to implement. When it comes to data management, electronic data capture (EDC) systems should encourage organizational best practices for data quality rather than deter them. The best EDC systems are easy-to-use and intuitive for all staff members, and ultimately reduce the potential for error when reporting into the system.

Need an easy-to-use EDC system?

Trovend EDC allows users to build custom forms, set up edit checks and use forms across multiple protocols to decrease duplicate data entry and error. Learn more about how Trovend EDC can streamline your data collection, management, and compliance. Start the conversation.