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Applied Clinical Trials spoke to Roy Devine, Associate Vice President at Patni Life Sciences, a technology consulting and integration firm, about technology issues recently. One pressing issue that may become more important for sponsors in the coming months is in regard to the EU's Clinical Trials Directive. Specifically, sponsors may be concerned about the recent uptick in enforcing the requirement that sponsors know that their investigators are reading, understanding, and signing crucial safety documents or SUSARs (suspected unexpected serious adverse reaction reports).
"The EU reporting requirement has been around for a few years, but now it's being enforced," explained Devine. "Sponsors don't have a technical way to make sure that investigators have read the information on safety." So what he is seeing now is an increase in companies cited for underreporting.
Devine does not fault the sponsors at all. Basically, the situation is that some of the sponsors keep this information in an Excel spreadsheet, which doesn't have the level of "riguer" necessary for tracking. "Sponsors are good at sending information to the regulatory authorities and are comfortable with it," explained Devine. But in regard to the SUSARs and other safety reports for the regulatory authorities, sending out to the investigators is a bit of a hodge-podge. From faxing to Documentum to emailing, Devine described a blind distribution system that doesn't actually offer accountability.
"It is not a closed-loop system. There is nothing in the process that says you read and understood the document," said Devine. And that is what sponsors should be working toward now, a closed loop system that addresses these concerns. Devine said, "Some sponsors are doing it. And others aren't. But it is something that needs to be addressed."