The evolution of clinical data collection methods: from Excel spreadsheets to an EDC.
In recent years, electronic data capture (EDC) software has emerged as the preferred method for managing data in clinical trials. However, many research teams and study coordinators continue to use Excel spreadsheets to manage their trial data. While Excel is a useful tool for data analysis and visualization, it has several drawbacks when it comes to managing clinical trial data. In this article, we will explore the differences between EDC and Excel use in clinical trials and why using EDC software is the best choice.
What is an EDC?
An EDC (Electronic Data Capture) is a specialized system software for capturing, managing, and reporting clinical trial data. EDC systems provide a centralized platform for collecting data electronically, making it easier to manage and monitor study data in real-time. The system allows authorized users to access and manage data remotely, reducing the risk of data loss and ensuring data accuracy.
Benefits of using an EDC
01
Improved Data Quality
EDC systems are designed to minimize data entry errors and ensure data accuracy. These systems include built-in validation checks, conditional logic, data range and format restrictions, and user-friendly interfaces to prevent errors in data entry. EDC also eliminates transcription errors that often occur when data is manually entered into spreadsheets.
02
Faster Data Collection
EDC software can streamline the data collection process by automating data entry, reducing the time and resources needed for data management. This saves time and allows research teams to focus on other aspects of the clinical trial. EDC systems are also designed to handle large volumes of data, making it easier to collect, manage, and analyze data from multiple sites.
03
Better Security
EDC systems can improve compliance with regulatory requirements by providing an audit trail of all data changes and user activities. EDC software also enables secure data sharing among study collaborators, ensuring that only authorized personnel have access to study data.
04
Real-Time Monitoring
EDC systems allow research teams to monitor the progress of the clinical trial in real-time. This enables them to identify any issues or trends that need to be addressed quickly. Excel sheets require manual data entry and do not provide real-time monitoring.
05
Regulatory Compliance
EDC systems are designed to meet regulatory requirements, such as 21 CFR Part 11, ICH GCP, ISO 27001, and GDPR… which are essential for patient privacy and center compliance. Excel sheets are not designed to meet these requirements.
Drawbacks of Excel
Increased Risk of Errors
Excel is not specifically designed for clinical trial data management, and it lacks the validation and error-checking features of EDC software. This makes it more prone to errors, particularly when handling large volumes of data.
Demanding Data Entry
Excel requires manual data entry, which can be time-consuming, especially for studies with large sample sizes or multiple study sites. The manual data entry process also increases the risk of data entry errors, which can lead to data inaccuracies.
Limited Security
Excel files can be easily shared via email or file-sharing platforms, making it difficult to track who has accessed the data. This can lead to potential breaches in data confidentiality and security, which is a significant concern in clinical trials.
Lack of Compliance
As stated in a section above, using Excel spreadsheets for collecting sensible patient data isn’t compliant with current regulations. Indeed, using Excel cannot provide any insurance on how the data is collected, where it is stored, and who has access to it.
In conclusion, using EDC software is the preferred method for managing clinical trial data. EDC systems are specifically designed for clinical trial data management and offer several advantages over Excel.
They provide improved data quality, faster data collection, real-time monitoring, better compliance, and improved security. While Excel has several drawbacks that make it less suitable for managing clinical trial data.
By using EDC software, research teams, and study coordinators can ensure that their clinical trial data is managed securely, accurately, and efficiently.
Datacapt is the answer
Struggling with using Excel as a data management tool for your clinical trials should be something of the past.
Datacapt is an advanced EDC software that is designed specifically for clinical trials, providing a secure, easy-to-use, and centralized platform for data management that ensures data accuracy, improves data quality, and simplifies data collection.
With built-in validation checks and user-friendly interfaces, Datacapt eliminates the need for manual data entry and the potential errors that come with it.
Additionally, Datacapt offers real-time data monitoring and reporting, compliance with regulatory requirements, and customizable features to suit the unique needs of your clinical trial.
