The ubiquitous EDC system could be the answer to your SAE reporting prayer. Though a logical place to begin addressing SAE headaches might be by giving sites access to sponsors' safety reporting systems, EDC may provide more benefits.
Adverse-event and severe adverse-event reporting are poster children for process automation. Managing such events takes 10 to 20 percent of a study coordinator's time, says Ron Rubinstein of clinical trial solutions provider Medidata Solutions, in eCliniqua. Many of the processes are still manual. Data captured at sites is often keyed or re-keyed by the sponsor into a safety reporting system. Phone and fax follow-up to SAEs compound the data, yielding redundancy over multiple clinical systems. Data management teams are left to reconcile while also ensuring consistency and accuracy.
But EDC technology, now in use in close to 90 percent of all Phase 3 trials in the U.S., can be used to automatically transmit SAE case data to sponsor safety reporting systems. The EDC system, if used in subject recruitment, will already hold volunteer medical history and medication data. And since most safety reporting systems accept electronic case files in the ICH's E2B standard format for records transmission to regulators, an E2B-compliant EDC system that also supports automation of the SAE reporting process is equipped to provide SAE front-end reporting functions.
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