Safety Document Exchange in the Global Clinical Research Environment: Secure, Cost-effective, and Well-connected

The proper and timely reporting of Serious Adverse Events (SAEs) during clinical trials is under scrutiny.

The process for managing SAE intake, review and report distribution within the strict time frame required is becoming more costly and labor-intensive, largely due to the increase in the number of investigative sites participating in studies and the global distribution of sites.

When a sponsor receives an initial SAE report, the clock starts ticking. Typically reports are phoned in or sent via unsecured email, which poses risks that reports go missing, go to the wrong recipient, or get lost in a stack of messages. Once received, the SAE report is evaluated by the sponsor’s representative and a narrative is written to form the backbone of the SUSAR (Suspected Unexpected Serious Adverse Reaction) letter. The letter is then forwarded to regulatory agencies, investigators, IRBs/ECs and others for review within seven or 15 days of the event, depending on the severity of the event. Coordinating this communication can be diffi cult, even when all documents are properly in place; consider the additional stress that arises if an addendum to an SAE report is misplaced midway through the evaluation.

16 October 2014