Technology has become a cornerstone in the clinical trial landscape. Leveraging technology is essential to successfully streamlining the start-up and conduct of trials. From clinical trial management systems to electronic regulatory management systems, clinical research technology has been instrumental in making improvements in the entire protocol lifecycle.
One important aspect of trials impacted by technology is clinical data management, specifically how sites handle electronic source data for clinical investigations. The Food and Drug Administration (FDA) has put out a guidance document offering suggestions for sponsors, contract research organizations (CROs) and clinical investigators on how to handle eSource data. The guidance document emphasizes the benefits of capturing data electronically and recommends best practices when it comes to managing eSource data.
What is eSource?
Let’s first take a step back and discuss what electronic source data includes. The FDA guidance document defines an electronic record as “any combination of text, graphics, data, audio, pictorial or other information represented in a digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system”. An example of an electronic record is an electronic case report form (eCRF), which would often be completed via an electronic data capture (EDC) system.
Why is it important?
Collecting data electronically holds a number of advantages. The FDA guidance document promotes capturing source data in an electronic form in an effort to streamline and modernize clinical investigations. By doing this, it assists in ensuring the “reliability, quality, integrity and traceability” of data. Not only does this lead to more efficient clinical trial processes, it also helps make it easier for compliance with FDA regulatory guidelines, including 21 CFR Part 11.
In FDA regulated trials, source data needs to be reviewed by the FDA and the sponsor to ensure the trial is conducted ethically, and the quality and integrity of the data are protected. Source data should meet the ALCOA standard: attributable, legible, contemporaneous, original and accurate. Electronic methods of capturing source data help meet this standard much more easily than handwritten data on paper forms.
Where does eSource data come from?
Any data initially recorded in electronic format is eSource data. This could be data entered into an eCRF through an EDC system by a clinical investigator or delegated clinical study staff, data from a medical device, data from an electronic health record (EHR), automated laboratory reporting systems or other forms of technology.
Forte is committed to helping research institutions meet all the recommended best practices for eSource data through the use of Forte’s Electronic Data Capture System. Forte EDC makes digital collection of eSource data through eCRFs easy. Furthermore, in Forte EDC version 9.0, which is being released later this summer, organizations can interface their Forte EDC instance with their EHR system to automatically populate lab results to an eCRF, eliminating the need for duplicate data entry and reducing the potential for error.
Need an easy-to-use EDC system?
Forte EDC allows users to build custom forms, set up edit checks and use forms across multiple protocols to decrease duplicate data entry and error.