If a UTHealth physician/principal investigator is approached by an industry sponsor to participate in a study, the NP and department administrator must conduct a feasibility study to determine whether it is financially and operationally feasible to participate in the clinical trial. Past experience shows that people with different learning expectations and requirements sometimes attend this public course. (If this is done as an internal course, it usually doesn`t happen because we know in advance who will attend.) In order not to disappoint, it should be noted that the course is intended for those responsible for negotiating agreements on clinical trials, whether as officers, contract managers or legal advisors. The focus is on issues related to the drafting of contracts, including a range of legal issues such as employment status, intellectual property, data protection and who assumes regulatory responsibility. We look at typical contract formulations and the commercial and legal issues that these formulations raise. However, the course does not attempt to provide detailed training on regulatory compliance. This is a special subject in itself. In practice, the speaker notes that clients have their own regulatory specialists who advise on these topics and whose advice is integrated into the drafting of contracts. Negotiation skills can be applied to agreements on clinical trials, budgets and more for efficient and fair contracts. This one-day hands-on course offers an in-depth discussion of the legal, regulatory, editorial, and practical issues that arise when developing and negotiating Clinical Trial Agreements (CTAs) and other contractual documents that arise during the conduct of clinical trials, i.B agreements between a sponsor and a clinical research organization (CRO). Topics include: CTA is one of many key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, a site and a researcher, and describes the responsibilities and obligations of each party for the clinical trial. It is imperative that researchers and sites understand the importance of developing, negotiating and executing CTAs, as effectiveness in these areas increases efficiency, protects researchers/sites and subjects, and helps advance research.
While this is not strictly necessary, it may be helpful for participants to read one of the standard NHS clinical trial agreements. B for example the mCTA (Primary Care model Clinical Trial Agreement) and the accompanying guidelines. A clinical trial agreement is the contract between an industry sponsor and a university that sets out each party`s obligations to conduct a written protocol by the sponsor that includes human subjects and the trial of a drug or medical device. The following steps describe the most efficient process for initiating a private clinical trial to test biomedical drugs or devices in accordance with FDA regulations. This process allows OCTA to negotiate a clinical trial agreement while the principal investigator receives approvals from other campuses and compliance committees. This course complements the basic training of the basic biomedical course. Organizations can add the modules of this course to their core TGV courses to provide learners with targeted CTA training. This intensive and interactive one-day program focuses on CTAs in the pharmaceutical industry where legal, political and ethical considerations underpin the design of these agreements. Participants will have an overview of the legal framework for clinical trials in the European Union (and the United Kingdom) before taking a closer and in-depth look at the specific issues that need to be taken into account when developing a CTA.
Using a case study, participants will also review some examples of clauses and have the opportunity to practice negotiation skills in the safe classroom environment under the guidance of our expert faculty. By the end of the program, you will be more confident in recognizing and addressing the key issues that arise when negotiating and drafting ATKs, understanding how to best mitigate risks and how to deal with them effectively when they arise. .