eRegulatory Working Group Established

While most AACI cancer centers have in place a regulatory file system—either paper or an electronic system for the filing and version control of a trial’s required regulatory information—many utilize non-standard file-naming conventions. AACI Clinical Research Innovation (CRI) has established an eRegulatory working group to address the challenges that non-standard file names create.

By developing a standardized nomenclature for AACI members, external stakeholders—including auditors, trial site monitors, and community network trial sites—can simplify onsite and remote monitoring visits. Other benefits include improving access for auditors performing compliance reviews and facilitating access to active trials at network and affiliate sites to promote accrual to clinical trials.

The working group is comprised of AACI leadership and members from AACI cancer centers. The goals of the eRegulatory working group are to identify the challenges associated with working with non-standardized file names and to standardize these and create a site map for storing common regulatory trial documents to facilitate site monitoring. The first working group call will be held later this month.