The greatest attention in negotiating clinical trial budgets and contracts focuses on fair compensation for the conduct of clinical research. However, experience has shown that the highest risk in these negotiations is the result of rules and rules outside of good clinical practice (GCP), which can result in heavy fines and penalties for the unwary. This web-based seminar will clarify these rules and rules and provide practical guidance on how to navigate these waters safely. Investigators should provide MS with a copy of the draft clinical trial agreement (ATC), the protocol and a company contact person as soon as possible. If a master`s contract already exists between the sponsor and the University of California, the negotiation process is usually expedited. The IRB authorization is not necessary to present the PS proposal and start contract negotiations. This intense and interactive day program focuses on CTAs in the pharmaceutical industry, where legal, political and ethical considerations support the development of these agreements. Participants will have an overview of the legal framework governing clinical trials in the European Union (and the UK) before looking more thoroughly and comprehensively at specific issues to be considered in the development of a CTA. On the basis of a case study, participants will also review some examples of clauses and, under the direction of our expert panel, will have the opportunity to practice negotiation skills in the safe classroom environment. At the end of the program, you will be more confident in identifying and addressing key issues in the negotiation and development of ATCs, understanding how best to reduce risks and address them effectively when they occur. The university`s standard agreement for clinical trials and the clauses proposed by the university during contract negotiations are based on the following assumptions: This collective knowledge, when recorded and optimized, plays an essential role in decision-making in a project. It can help project teams create an excellent sense of the situation that leads to strategic and informed decision-making.
For example, the knowledge you have about the ease of awarding contracts to a particular study position can help you make an informed decision about whether or not to integrate the study into the feasibility phase. You can also make a business decision for your project and accept the use of a regional model in a given region, as you know that trying to change it can lead to unforeseen delays in reaching agreements. A clinical trial agreement is the contract between an industrial sponsor and the university, which sets out the obligations of each party for the implementation of a protocol drafted by the promoter, including human subjects and the examination of a drug or medical device. If you want to improve the management of your contract for clinical trials, five areas (in no order of importance) are to be explored. Even the smallest steps that will be taken in a consistent way will bring progress.