Clinical Trial Agreement Negotiation Guidelines

What exactly is a “registered compartment”? What is an “actionable” data set? How to define an “abandoned” patient? When is a report “closed”? What makes a patient “scanned”? A “randomized” subject? You should have operational definitions of these terms and these definitions should be included in your contract. Be sure to read the clinical trials agreement. Private for-profit sponsors, such as for example. B pharmaceutical companies, are motivated by forces other than the university. As a result, sometimes they do not understand the ideals and principles behind our policy. Therefore, additional time may be required to negotiate contracts, while SP cooperates with the sponsor to reach a mutually acceptable agreement. The ability to negotiate can apply to clinical trial agreements, budgets and more for efficient and fair contracts. Clinical trials are research-based studies that are conducted to determine whether a medical drug, device, or procedure (depending on the stage of the study) is safe and effective. A complete set of clinical trials covering all phases can cost hundreds of millions of dollars normally paid for by a sponsor such as a government agency or for-profit company. Increasingly, clinical trial activities are entrusted to a service provider such as an Academic Medical Center (AMC), a Contract Research Organization (CRO) or a medical practice, and this outsourcing requires the negotiation and implementation of a Clinical Trials Agreement (CTA).

Therefore, an ATA between the sponsor and the organization is required to conduct the clinical trial. This article examines several critical points that need to be considered in the development and negotiation of an ATK from the perspective of a GAC. A court decision, or even mention it in a lawsuit, can ruin a company`s reputation or financial capacity. Therefore, a CTA should consider whether one party compensates, defends and/or keeps the other party compensated. Depending on the nature of the organization conducting the study, the conditions of compensation may be decisive and, therefore, CTA should explicitly define the conditions of compensation, including any requirements for termination and/or cooperation and exclusions of liability. In addition, a party`s insurance coverage, and even its liquidity, can determine the amount and extent to which the party can effectively meet its indemnification obligations. in the absence of provisions contained in a sponsored research agreement or in the CTA. . . .