Electronic data capture (EDC) has emerged as the predominant way to collect data during clinical trials. At OmniComm Systems, we’ve seen the application of EDC across all therapeutic areas and phases of clinical trials. EDC has become the norm in terms of the way pharma companies operate and collect data from clinical sites. However, it’s still reasonably normal to see serious adverse event (SAE) data be initially reported from sites on paper.
Regulatory authorities have begun implementing the updated standard for Adverse Event Individual Case Summary Reports (ICSRs), known as ICH E2B (R3), with the goal of improving the quality of the data submitted. Increased quality could be influenced by having a more streamlined approach to receiving data from investigational sites in the first place. This creates opportunities for EDC systems to become the electronic “system of record” for such data, helping to remove manual processing and data transcription that can impact the quality of data ultimately submitted.
“A key intention of the revision of the standards for submission of ICSRs is to improve the inherent quality of the data and to enable improved handling and analysis of ICSRs,” according to a report presented by the FDA.
The desire to report Clinical Trial ICSRs with better quality can push downstream to place new demands on the EDC system, thereby requiring additional flexibility, review and oversight capabilities. At OmniComm, we have a solution that fully addresses the complexity of the data-reporting challenges created by the latest guidelines.
Key Differences Between E2B (R3) and the former E2B (R2)
Before the update, E2B (R2) was the reporting format. Both E2B (R3) and the E2B (R2) are in XML format, but the E2B (R3) format includes more information than previously collected in the E2B (R2) format. The latest format also has more structure and information embedded within it. Bottom line: E2B (R2) is a much simpler representation of the data compared to E2B (R3).
Challenges E2B (R3) Present to Organizations
The need to get data in a specific format like E2B (R3) means that research organizations can face technical challenges in terms of converting data into the standard from whatever original format used to collect the data. In many cases, the data originates from sites on paper. Pharmacovigilance systems may address this need, but the job can be made so much easier if they are fed from an electronic system of record such as EDC.
To do so requires not just the technical exchange of the data from one system to the other. In fact, just being able to get your data into E2B (R3) format won't solve the problem. You need to be able to control exactly what data is converted and how it gets converted into a format that will enable your company to use E2B (R3) format to maximum advantage.
EDC Helps Organizations Manage Pharmacovigilance Requirements
Electronic data capture alone doesn't help organizations manage requirements; it takes an electronic data capture solution that provides the pharmacovigilance users the appropriate interface to manage that safety data and prepare it for its downstream use to properly facilitate an electronic process for reporting serious adverse event information. Sites can be guilty of over-reporting or mistakenly reporting information, and so just electronically exchanging data from EDC into Pharmacovigilance could create other case management issues unless a proper data governance process can be supported.
It is possible to facilitate a truly electronic reporting process for serious adverse events collected at sites, through to consuming that information within specific pharmacovigilance systems, and then subsequently reporting of that information to the regulator. In subsequent blog posts, I’ll illustrate some of the challenges in more detail.