Contracts and Budgets

Abstract

The clinical research landscape in the twenty-first century continues to evolve. Over the last three decades, the clinical trials landscape has changed dramatically with increased regulations, worldwide standards (ICH E6 Guidelines), and intense scrutiny. Most recently, there has been substantial impact from changes to legislation on data protection (US Health Insurance Portability and Accountability Act, EU General Data Protection Regulations) rather than legislation directed specifically at clinical trials. There is an increase in large multicenter clinical trials, many of them international in scope. Trials are increasingly becoming more automated and complex in their design, management, and implementation.

The complexity of the clinical trials environment and the increase in regulations requires all those involved, whatever their level of contribution, to adapt to the changes and to be very clear on the costs associated with carrying out research (Mashatole, Conducting clinical trials in the 21st century- adapting to new ways and new methods. Retrieved from https://www.clinicaltrialsarena.com/news/conducting-clinical-trials-in-the-21st-century-adapting-to-new-wasy-and-new-methods-4835722-2/, 2016). Equally important, the terms of agreement and division of responsibility between relevant parties involved in a trial, including the Sponsor and/or funder, must be clearly specified in advance in the form of a legally binding agreement.

This chapter provides guidelines for preparing Clinical Trial Agreements/Contracts and for developing budgets/funding requests for the work involved, both essential activities during the start-up phase of a trial.