To promote the work of its member centers, AACI publishes Commentary, an editorial series focusing on major issues of common interest to North American cancer centers.
Each AACI Commentary is written by a cancer center leader and distributed by email to the more than 2,200 readers of the AACI Update newsletter.
The publication is designed to cover a specific topic in 750-1,000 words. Recommendations for topics and authors are encouraged.
By the AACI Regulatory File Management Working Group
To help create a common nomenclature for cancer clinical trial regulatory file systems, AACI established a Regulatory File Management Working Group in October 2018, comprised of AACI leadership, members from AACI cancer centers, and other relevant stakeholders.
After polling cancer centers about the types of regulatory file management systems in use, the working group found that many centers were in the process of either choosing an electronic regulatory (eRegulatory) system vendor package or developing their own cloud-based system. The survey’s findings created an opportunity to share lessons learned by centers that had adopted eRegulatory binders.
In formulating recommendations for implementing an eRegulatory system, the working group landed on a set of guidelines structured around three broad categories: planning, training, and expansion.