Meshing the Gears of Education and Training

Clinical Researcher—November 2018 (Volume 32, Issue 9)


Gary W. Cramer



I am always doing that which I cannot do, in order that I may learn how to do it.—Pablo Picasso


As I see it, here’s the rub: You can have the best education possible upon entering a new job, but never receive effective training for putting your learning into action. Likewise, you may be gifted with top-notch training for your new duties, but lack the educational background to capitalize on it to the fullest extent possible.

What’s an organization to do? Trainers can’t turn back time to correct the early-education shortfalls, and educators can’t gaze into a crystal ball to see where their students will land in their job searches. Meshing the gears of education and training seems to me to be an urgent matter of the “here and now,” and this takes on a very serious tone, indeed, within the clinical research enterprise, where so many new hires know so very little about the field they have just joined.

Caution: Learning Ahead

This issue of Clinical Researcher presents several of the many possible angles from which to attack the education/training conundrum. First up, in “Develop a Comprehensive Learning Needs Assessment for Your Research Staff,” the Aurora Research Institute’s Tracy Graham examines how the “foundation of a successful continuing education plan is a comprehensive learning needs assessment.” She summarizes key strategies for conducting a learning needs assessment that will help you efficiently identify the specific needs of your staff.

Next, in “The Necessity of Clinical Research Documentation Training Programs and the Value of Learning from Mistakes,” The Ohio State University Wexner Medical Center’s Paula Smailes writes, “Clinical research documentation is heavily scrutinized to ensure compliance with federal regulations. Because of this, it is imperative that investigative sites have a structured program for training new hires and ensuring annual competency for existing staff.” The benefits of such programs can accrue to a site’s reputation for study conduct as well as to its patient safety achievements.

Last but not least, Melissa Kadar and Lindsey Sikora, both from OhioHealth Research Institute, consider “Applying Lean Methodology to Improve the Informed Consent Process”—a key clinical trials process that nevertheless lacks detail both in terms of official regulation and guidance. They write that “[i]ncorporating process improvement measures in a CAPA plan can facilitate realizing the expected outcomes of corrective actions. Utilizing established continuous improvement methodologies, like Lean, can be beneficial.”

And More to Come…

Several additional articles solicited by Guest Editors Smailes and Shirley Trainor-Thomas, both members of the ACRP Editorial Advisory Board, did not make it through the full review and revision process in time for this issue, but will be featured in upcoming months. Many thanks to them for their efforts to shed light on the workings of these education and training gears, and to the columnists whose insights enhance this theme.

Gary W. Cramer ( is Managing Editor for ACRP.