Keys to Selecting an EDC System
Benefits of Electronic Data Capture
Electronic Data Capture (EDC) is a very important tool used for data collection in clinical trials. The benefits of using an EDC system are well understood:
More rapid and ongoing access to study data
Monitoring and query resolution in an ongoing fashion
Early identification of data collection issues
Efficient data tracking and log changes
Integration of coding, file storage, and project communication on a single platform
Despite the obvious advantages of using an EDC system, companies will still use paper forms or spreadsheets, typically due to the cost of the deploying an EDC system. While cost is a sufficient driver for that decision, there are frequently hidden costs such as lack of any audit trail for the data. It may be more difficult to identify problems, and data will still need to be imported for analysis later. Incorrect, incomplete, and poorly structured data, at a minimum, will either cause delays or later costs.
At Stat One, while we are very comfortable using data from almost any source, we emphasize the value added when using an EDC system for clinical trial data. Our team has outlined the specific key elements to selecting the right solution for you.
Cost: The 500lb Gorilla
|Type of Cost||Description|
Cost associated with accessing the system. These may include:
The cost of designing and implementing a database in the EDC system. This cost will include these activities:
|Database Validation||The cost of confirming and documenting that a database operates as designed. This typically includes at least two components: User Acceptance Testing (UAT) and Electronic Check Testing (ECT). Note that the purpose of this step it to validate the database operates as it was designed to and is separate from validation of the actual EDC system.|
|User Training & Documentation||Data entry guidelines are typically documented and provided to study site users. In addition, there may be a cost to training users on the system.|
|Data Monitoring & Data Cleaning||Site monitoring involves the cost of confirming the site is both performing it administrative and subject source document tasks, but also will help evaluate data quality and identify data issues. Data cleaning may be augmented by a data manager who focuses on data quality through additional checks and data review.|
|Data Export for Analysis||This can be an indirect cost. While, frequently not an issue, this can create additional costs if the data are not structured well for analysis, or the system does not provide a useful export format.|
Monitoring and data cleaning are not limited to an EDC system and the use of an EDC system may both reduce the cost of these activities and improve the quality of data by providing more real time data assessment.
Stat One EDC pricing is based on monthly services with a flat price despite the number of users or sites, does not require a set-up feel, and the service can be canceled at any time.
EDC System Functionality
|Was the EDC built to clinical trials?||A clinical trial database should be built to handle sites easily, incorporate a standard clinical trial visit structure, and build forms that align with traditional paper forms or CDISC data types.|
|Does it provide flexible data types?||The database should include at least the standard range of web page field types: radio buttons, drop-down fields, check boxes, text fields, expanded text boxes, and handle date/time values. Good databases will typically avoid using a lot of free-text fields unless necessary.|
|Do the screens provide build in display control and checks?||Database forms can help avoid errors if they can conditionally show or hide child questions, identify missing values, and provide range checks.|
|Does the system have a robust query system?||Does the system have an easy way to address cross form or complex multi-field checks as part of the query process.|
|Data derivation capability and messaging?||Can the system be used to create data derivations and/or send messages based on database form values?|
|Is it easy for the sites to address and resolve queries?||The two biggest EDC tasks for a site are data entry and responding to queries, a system should facilitate these actions to the extent possible.|
|Reporting and summary tools?||Ideally it should be possible and not too difficult to get reports from the database that are sufficient for review and/or ongoing data tracking|
|Is data import capability useful?||If you need to import data rather than do direct data entry, make sure this capability exists.|
|Output formats?||Does the system out data in a format you can use for analysis and how ready are the data structures for analysis?|
|Is the adequate trail and user controls sufficient?||There user controls and reporting of data changes should be sufficient to be part of a process that meets CRF 21 part 11 requirements.|
Stat One EDC was built-to-task as a clinical trials system to meet these requirements.
Additional System Features & Access Method
|Access method, server-based vs application-based.||Server- or web-based system that require internet access may not be acceptable if reliable access can be assumed. In that case, an application-based system or tool that is system compatible may be needed to save entry values for later upload.|
|eConsent capability||eConsent allows regular tracking of enrollment in the study, reduces site overhead, and can be used to spawn subjects into a database. Not all systems incorporate this option and there are third party providers.|
|ePro capability||This covers the ability of the system to incorporate system entry direct from a study subject. This may be through an app or web-forms.|
|Subject randomization||The ability to randomize a subject and appropriate inform other parties from within the system.|
Stat One EDC includes a randomization functionality and is exploring these other functions for future capabilities. Stat One EDC is server-based through a web-browser, hence requires internet access.
Provider Experience: A Straw that Can Break the Camel’s Back
Stat One EDC® was built with the analysis in mind based on experience obtained from analyzing hundreds of studies. Stat One’s analysis experience has included using databases from many different systems including many of the top EDC providers today. Just as a bad driver can put any car in a ditch, an experienced database builder can use any system to build a bad database. Further, cost does not always equal quality. So due diligence in assessing providers should not be ignored.
Stat One has been part of many successful study design, database design, and data analysis. Stat One’s CEO, George DeMuth, has over 30 years of industry experience in statistics, data management, and software design.
Stat One EDC®
The Stat One EDC® system is a comprehensive electronic data capture system that is scalable, making it an ideal solution for small, mid, and large-sized firms. Stat One offers a cost-effective solution balancing system intuitiveness and ease of use. Our solutions achieve better data without the need for extensive database training. Stat One EDC® has built-in features and to help simplify design processes and collection of data.
Whether you are looking to streamline data entry or ensure data quality, Stat One EDC® is an excellent electronic data capture choice. Stat One also offers custom integrations, including Stat One ValTrack®, which is used for tracking system files, validation status, and collecting information on system findings. With Stat One’s team of experts, you can be confident in your data and data analysis.