Leverage Data Managers to Strengthen Risk-Based Monitoring Programs

Jan Peterson, Senior Regulatory Affairs Manager and Project Director, Emmes Corporation

Jan Peterson, Senior Regulatory Affairs Manager and Project Director, Emmes Corporation

Data managers play a critical, and perhaps under recognized, role in fully realizing the potential of risk-based monitoring (RBM), Jan Peterson, senior regulatory affairs manager and project director at Emmes Corporation, told attendees of the Association of Clinical Research Professionals (ACRP) 2017 Meeting & Expo in Seattle April 29.

RBM remains a murky concept in some ways, even down to the very term itself. “I have a pet peeve about the label,” said David Burrow, acting director of the Office of Scientific Investigations (OSI) for the Food and Drug Administration’s Center for Drug Evaluation and Research. He argues that the designation doesn’t always make it clear that the process itself should start “a few steps earlier,” in terms of beginning with protocol design. Still, he remains a fan of RBM.

Data managers can be more effective when engaged at early protocol development, Peterson and fellow panelist Denise King, also a project director with Emmes Corporation, agreed. If woven into the process, data managers can help design data processes and case report forms to utilize statistical and other techniques that assess incoming data for anomalies likely to reveal quality problems.

Data manager participation and statistical approaches to centralized monitoring are essential components of RBM, King said.

Despite all the press it has received, including cover treatment in a 2013 issue of ACRP’s peer-reviewed journal, RBM is “old news with a new name,” Peterson said, citing its inclusion in International Council on Harmonization documents on Good Clinical Practice going back to 1996. “I came to this ACRP conference in 2014 after [the ACRP journal issue that focused on RBM] and saw a crowded room of clinicians who thought they were going to lose their jobs,” he added. “They won’t,” he assured the 2017 crowd.

“Resource shifting may be needed to be effective, and your data managers are already working with data quality issues daily, making them a key resource in your overall quality mission,” Peterson said.

Author: Michael Causey