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Synchronizing Serious Adverse Events and Electronic Data Capture using E2B

Posted by Rich Davies on Oct 30, 2016 5:32:59 PM

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.

New guidelines from the Food and Drug Administration, such as the ICH E2B (R3), have created new challenges and opportunities for EDC systems. For example, ICH E2B (R3) requires serious adverse event reports to be compiled and sent to pharmacovigilance groups in a standardized format.

“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 updated FDA guidelines place new demands on the EDC system, 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 regulatory 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).

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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.

But the updated process requires not just the technical conversion of the data from one format 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 related to serious adverse event information.

Electronic data capture can also be used to automate transmission of E2B-formatted serious event reports to the appropriate pharmacovigilance team. 

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.

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 onward reporting of that information to the regulator. OmniComm's TrialMaster EDC and SafetyLink ensure a more efficient SAE reporting process. 

Learn What it Means to Work with an EDC Specialist

Tags: edc, Electronic Data Capture, Data Management, TrialMaster EDC, safety reporting, E2B, pharmacovigilance, adverse events, SafetyLink