Tuesday, April 21, 2015

Remote SDV/SDR: Alternatives to Redact/Fax

By Laurie Meehan

As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV).  The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites.  This happy outcome relies on the right combination of enabling technology, privacy/security policies, and source documentation procedures.  At its most elegant, monitors can coordinate with the sites to receive (i) remote, (ii) temporary, and (iii) restricted access to their EMRs.  All quality review of source documentation can be conducted off-site.  Questions and queries about the source data can be also resolved remotely, sometimes by phone and sometimes using online meeting software like WebEx.  With SDV/R complete, on-site monitors can focus on assessing other, more “presence-demanding” study elements, such as drug accountability and PI oversight.