Introduction: Heightened concerns about industry influence on continuing medical education (CME) have prompted tighter controls on the management of commercial funding and conflict of interest. As a result, CME providers must closely monitor their activities and intervene if bias or noncompliance with accreditation standards is likely. Potential for industry influence can be difficult to assess at a stage in the planning process when mitigation strategies can assure balance and content validity. Few tools exist to aid providers in this regard. Methods: A 12-item instrument was designed to assess risk for commercial influence on CME. To determine reliability and validity, a cohort of experienced CME professionals applied the tool to standardized "cases" representing CME activities in the early stages of planning. Results were compared with the experts' assignment of the same cases to one of four risk categories. A survey of study participants was conducted to ascertain usefulness and potential applications of the tool. Results: Analysis demonstrated strong intraclass correlation across cases (0.90), interrater reliability (94%), and correlation between assessment of risk with and without the tool (Spearman coefficient, 0.93, p less than 0.01; weighted kappa, 0.59). Participants found the tool easy to use and of potential benefit to their CME office. Discussion: The Consortium for Academic Continuing Medical Education (CACME) risk stratification tool can help CME providers identify activities that must be closely monitored for potential industry influence, remain aware of factors that place programming at risk for noncompliance with accreditation standards, and substantiate the allocation of resources by the CME office. (Contains 1 figure, 2 tables and 2 notes.)