Budget Development and Negotiation for Investigative Sites

Anna K. Rockich, MS, PharmD, Director, General Surgery Research Program, University of Kentucky Medical Center

Abstract: Effective budget development and negotiation is critical for investigative sites. This article provides an overview of budget requirements for the conduct of a study, identifies common mistakes in developing budgets, and highlights how to effectively develop the budget and negotiate with the sponsor. Tools to assist in managing the budget on a daily basis are provided.

Introduction

Study coordinators wear many hats, including organizing study operations, writing the institutional review board (IRB) submission, maintaining ongoing IRB communications, obtaining informed consent, administering investigational drugs and devices, monitoring study subjects, collecting data, and working with sponsors. Budget and billing are two of many responsibilities.

Protocols have become increasingly complex, and sponsors are demanding more work by investigative sites. According to the Tufts Center for the Study of Drug Development1, in 2000, the median number of unique procedures per protocol was 20.5; by 2011, this had increased to 30.4 unique procedures per protocol. The number of unique procedures per protocol in 2016, although not yet quantified, will be exponentially higher. The total number of eligibility criteria has also increased, from 31 in 2000 to 49 in 2007, the last date for which data are available. Scrutiny on inclusion and exclusion criteria has also increased. The median number of case report form pages per protocol has increased from 55 in 2000 to 180 in 2007.

It takes about five years for a study coordinator with minimal experience to become relatively autonomous, in the author’s opinion. Budgeting and contracting are generally the last skills that study coordinators are taught. The author recently met a very experienced study coordinator who has worked as a study coordinator for 15 years. She had never, however, developed a budget. Locally, at least at the University of Kentucky, available curriculums for training on budgets and contracts are limited. On-the-job training requires time and good mentors. Study coordinator turnover is another issue. Study coordinating is a vocation not suited for all. Some people enjoy research while others do not, and they move on to other positions or disciplines. The author must continually train new study coordinators.

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