AACI Commentary

About Our Editorial Series

Exploring Topics of Interest to AACI Cancer Centers

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. 

Please submit suggestions to: 

Chris Zurawsky
Director of Communications and Public Affairs

Emily Stimmel
Communications and External Relations Coordinator

October 2019

Less Paper, Better Trials
Recommendations for Implementing an Electronic Regulatory Document Management System

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.

Read the October 2019 Commentary.

Less Paper, Better Trials: Recommendations for Implementing an Electronic Regulatory Document Management System
By the AACI Regulatory File Management Working Group
October 2019

A Future Without HPV-Related Cancers is Within Reach: Eliminating Cervical Cancer is the First Step
By Anna R. Giuliano, PhD
September 2019 

Simplifying Clinical Trials: Using Technology to Improve Operations
By the AACI Shared Investigator Platform (SIP) Task Force
August 2019

Disclose and Manage: Recommendations From the AACI Conflict of Interest Task Force
By Karen E. Knudsen, MBA, PhD, and Leonidas C. Platanias, MD, PhD
July 2019

Inventing the Future of Oncology Nursing 
By Laura Fennimore, DNP, RN, NEA-BC
June 2019 

Ensuring Patient Access to CAR T Therapy: AACI Responds to CMS Medicare Coverage Proposal
By Richard Bondi and Clint Divine
March 2019

Zip Code vs. Genetic Code: Breaking Down Cancer Disparities in Philadelphia
By Karen E. Knudsen, PhD
October 2017

Satisfaction with Oncology Quality and Clinical Operations: A survey from the AACI Physician Clinical Leadership Initiative (PCLI)
By Morgan Dodson, Michael Neuss, Laura Hutchins, Richard Lauer, John Sweetenham, Nathan Levitan, Martha Mims, Mohammed Milhem, Craig Bunnell, Dan Mulkerin, Randall F. Holcombe
Fall 2017

SF CAN: A City Working Together to Fight Cancer 
By Alan Ashworth, PhD, FRS
Summer 2017

Integrating Clinical Research into Clinical Care
By Martha Mims, MD, PHD & Sarah McNees, PHD
Spring 2017