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. Therefore, CTA should require each party (i.e.: Academic institutions to have guidelines and regulations that define what may or may not be accepted in a clinical trial contract. Policies focus on protecting participants as research subjects and minimize responsibility for human research. When will the responsibilities of the parties begin and when will they end? From the notification of adverse events to inventions, from the transmission of regulatory communications to reports, from the termination of the agreement to the proposal for publication, from the protection of confidential information to the return, from billing to payment, the agreement is filled with deadlines governing the responsibilities of the parties. This article examines several critical points that need to be considered when developing and negotiating an AOC from the perspective of a GAC. . .


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