Narrowing the Definition of Part 11's "Contemporaneous"
FOR IMMEDIATE RELEASE:
AUSTIN, TX - June 29, 2017 - At a recent quality conference, CVM had an opportunity to discuss the idea of field-by-field submission of data. CVM expressed the desire to “get to the point where” contemporaneous audit trail tracking means that the time stamps for each field on an eCRF reflect the actual time of entry for that specific field on the web form.
Traditionally, the industry standard for audit trail tracking the date/time of field entry coincides with the action of a user saving the web form. If the user entered a patient name on an eCRF at 10:02 a.m. but did not Save the form until 10:05 a.m., the audit trail would show the patient name as being entered at 10:05 rather than 10:02.
However, a new standard is emerging! Alicia Browner, Ph.D., CTO of Prelude Dynamics shared, "After conversations with CVM following their presentation at the SQA conference where they indicated their desire to capture audit trail data for a form more contemporaneously - in other words, as fields are typed into rather than just when the form is submitted, we decided to deliver."
While Prelude Dynamics has always had a field-by-field audit trail, its newest release, VISION™ 9, includes the real-time stamps in the audit trail reflecting the actual time each field entry was made. VISION™ captures date, time and author as the user moves from one field on the form to the next, tracking even when it’s been just a few seconds between field entries.
Prelude’s field-by-field process meets CVM’s goal right now, before it becomes an FDA/CVM requirement, and enables Prelude’s clients to impress FDA/CVM with their enhanced compliance before the feature is even available elsewhere.
This solution is already in use in recent studies, and delivers the FDA’s vision for the future of EDC. FDA directors explained that the desire to capture immediate audit trail information stemmed from a desire to mimic some of the properties of paper – similar to when someone scratched out an entry on paper or filled the fields out on a form in a strange order – and to better show the contemporaneous nature of the data within a narrower window.
Just a few months after these conversations with CVM, the fully validated solution has been delivered. Field-by-field is currently being requested for multiple studies using Prelude as their study build solution and some clients, such as AlcheraBio, an animal health CRO, have made the feature their default operational mode.
The speedy addition of this feature demonstrates yet another way in which Prelude’s Clinical Trial Optimization Platform (CTOP) goes above and beyond to quickly incorporate elements to raise the bar for compliance with FDA requirements, add efficient evolving technology, and improve Client ease of use and functionality.
Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, VISION™, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. VISION™ facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.
Jim Pedzinski - VP of Business Development
jpedzinski[at]preludedynamics.com - 512-476-5100 ext. 210