The electronic case report form (eCRF) is a tool to gather all the data from different electronic and paper based systems. It is important because it makes it possible to assemble and organize diverse data in a manner that fulfills the study protocol and allows the data to be reviewed and analyzed. Data from clinical studies must be integrated for FDA submission and it is beneficial if the data is collected in a standardized format from the start. Standard forms mean simplified electronic data capture (EDC) system training for in-house and site staff. They also streamline the flow of data from collection through submission, whether a single or multi-site study. Data exchange between partners and providers is facilitated, and reviewers can then work with the data with less preparation time.
How It Works
Users can standardize the way the fields and data on a form map to a database. eCRFs can be created with one standard in mind and the work can be reused without having to create a new eCRF the next time users begin a study. Content standards, such as related metadata, definition and element name, can be mapped with easy access to a set of global data collection fields.
OmniComm works with a sponsor and/or CRO to build standardized eCRFs into the EDC system at the beginning of every clinical study. The process typically begins with defining the code lists, followed by the items, the groups, the forms and the visits. Items may be reused across groups. For example, an item “Med start date” could be placed in both a concomitant medications and a prior medications group. Similarly, the same group may be reused across forms, with properties such as the maximum number of allowed rows adjustments, which are potentially different on each form. Finally, each form is associated with the visits which may occur, with the maximum number of form occurrences specified as a property to avoid error. The next step is to layout the actual forms and make any needed edits. The final layout will be exactly the same across all platforms used during a study.
Why It Works
Companies are reaping the benefits of standardization across clinical trial research through the use of standardized forms and report libraries. Many biotechnology, pharmaceutical and contract research organizations can now streamline their clinical trials to reduce personnel costs of entering the data from paper. The entire clinical trial management process is simplified by using a library of standard cross-study eCRF modules. Even more important, standardization makes it possible to go from trial implementation to live eCRF database employment much quicker for faster clinical drug development.
Safety monitoring and data management are also enhanced by real-time transmission, review and assessment of patient data. By having data in set formats, key pieces of information across multiple trials and the identification of trends are possible. Built-in data edit checks allow for users to catch possible issues immediately and make the adjustments immediately. Better ensuring accurate and genuine data that is ready for submission to the FDA.
To some, eCRF standardization may seem like a tedious necessity that they wish they could skip over. However, OmniComm, an innovative EDC provider, understands its importance to the design and management of the entire study. A successful study starts with a solid foundation and eCRFs are a major component of every study’s electronic data capture system base.