UNMC researchers’ book honored among year’s ‘most valuable’

R. Jennifer Cavalieri	Mark Rupp, M.D.

A book written by two UNMC health professionals has been selected as one of the most valuable books of 2013 by the American Journal of Nursing.

Written by Mark Rupp, M.D., chief of the division of infectious diseases, and Jennifer Cavalieri, nurse coordinator in infectious diseases, the book provides tools for how to best manage clinical research.

“Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research,” was called “a much needed handbook for all research team leaders and managers” by one reviewer.

Drawing on more than 20 years of experience performing clinical trials, Cavalieri and Dr. Rupp share their practical knowledge in a manual directed primarily toward research coordinators and investigators. Cavalieri has been the research coordinator for federally-funded, investigator-initiated and industry-sponsored trials, a clinical trials office manager, and a patient recruiter. Dr. Rupp has worked on federally-funded, investigator-initiated and industry-sponsored trials at phases II, III and IV.

Dr. Rupp says Cavalieri was the driving force for the book. Cavalieri says the goal was not to write another book on research theory or another regulatory book, but instead to write a book to help new coordinators and PIs manage risk, organize documents and prepare for contingencies.

The AJN review says the book provides reality-based examples and that it has an excellent format — not too lengthy and not too short.

There are stand-alone chapters that can be referred to as needed. It also contains lots of tables and templates that Cavalieri developed over the years to keep track of studies.

“Clinical research is becoming increasingly regulated and complex, and research projects should be fiscally self-sufficient,” Dr. Rupp said. “This manual really stresses the steps and tools that are needed to keep clinical trials on track — everything from constructing the initial budget to payment reconciliation and closeout.”

“This is a ‘getting from here to there book’ that shows how everything comes together on a daily basis,” Cavalieri said.

Rupp and Cavalieri are quick to point out that their book is just one more resource available to the campus, reminding people of the Clinical Research Center and its training sessions, the IRB monthly educational series and two local professional groups for research coordinators.

With UNMC positioned to grow its clinical research portfolio, the release of this clinical research manual couldn’t be better timed, said Deborah Vetter, director of the Sponsored Program Administration, who saluted Cavalieri and Dr. Rupp for their work.