Draft Clinical Trial Agreement

A pharmaceutical product, medical device or other industry sponsor typically sends a Confidentiality Disclosure Agreement (CDA) or other non-disclosure agreement (NDA) to the Principal Investigator. The investigator or his staff should send any ADCs or NDAs they receive from an industry proponent to the appropriate CONTRACT AND GRANT OFFICER of the SRO for review and signature. Once the CDA is completed, the proponent sends the protocol, the CTA and the proposed budget. Use this article as a guide when reviewing or writing your next agreement for a clinical trial. However, you should always seek advice from a qualified lawyer on all CTA conditions. For all proposed industry-sponsored clinical trial agreements, the Department should create an InfoEd Proposal Development (PNR) development dataset. In addition to a completed application form, the RHA requires the following documents for review: Clinical trials are research-based studies conducted to determine whether a medical drug, device or procedure (depending on the study phase) is safe and effective. A complete set of clinical trials covering all phases can cost hundreds of millions of dollars, which are typically paid for by a sponsor such as a government agency or for-profit company. Increasingly, clinical trial activities are outsourced to a service provider such as an Academic Medical Center (CMA), Contract Research Organization (CRO) or medical practice, and this outsourcing requires the negotiation and execution of a Clinical Trial Agreement (CTA). Therefore, a CTA between the sponsor and the organization is required to conduct the clinical trial. This article examines some critical points to consider when drafting and negotiating a CTA from the perspective of an AMC. This section of the agreement is often overlooked by sponsors, CROs, and locations.

The purpose of this section is to explicitly state the description of the research project. You would like to document the overall purpose of the agreement in this section. In this article, I will present nine key elements of a Clinical Trials Agreement (CTA). You will learn the purpose of these components and how they can protect you in case of conflict or disagreement. But what if the clinical location provides incomplete or incorrect data to the sponsor? Or is he reluctant to allow a CRO to monitor data on-site? If one of the parties to the Contract decides to take legal action, this Agreement will specify the jurisdiction in which the matter will be dealt with. Finally, this section of the agreement must clearly indicate where the website must send invoices (name and contact details of the person) as well as the terms of payment (example: payment is made within 45 days). In general, the purpose of a clinical trial is to collect data on the safety and efficacy of a particular medical device. It is not surprising to us that clinical research is a regulated industry. On the other hand, proponents and CROs are required to inform the IRB/EC directly of any non-compliance that could affect the safety and well-being of subjects. When negotiating a CTA, the parties should assign responsibility in the event that a study participant is injured as a result of their participation in the clinical trial.

Several considerations determine whether the sponsor must pay the participant`s medical bills. B under consideration, for example what type of study will be conducted, the study phase, whether the product is FDA approved or not, whether the product is used off-label, whether the use of the product is considered a standard treatment, whether federal or foreign laws determine who is responsible, and whether a private insurer would cover the costs. Answering these questions will allow the parties to properly assess who should be responsible for the harm suffered. In a CTA, it is crucial to identify the party with whom the CMA is negotiating. This may seem strange, but it is important to ensure that the party is a corporation or has the authority to act on behalf of the proponent in the case of a CRO. In addition, the IDENTIFIER and address of the company must be included in the agreement. The person signing the agreement must be an authorized representative who can legally compel that company to fulfill the obligations set out in the agreement. It is also important to identify the Principal Investigator (PI) responsible for conducting the study and determine if the Principal Investigator is an employee of the organization. Otherwise, the IP may be considered an additional party to the CTA with personal obligations under the CTA. Or a clinical website published data from study participants without giving the sponsor the opportunity to review the results. The purpose of this section is to document the agreement between the site and the sponsor on how long the study data will be retained after the study has been completed (usually at least two years). The attribution of ownership rights to the data and inventions that may result from the conduct of the study is very important in a CTA.

The transfer of rights can depend on several factors: is the sponsor a startup or an established company? Is the product/use of it authorised or in the testing phase? What is the phase of the study? What type of organization does the study conduct? These factors affect the property rights that the parties seek in the Agreement. For example, the CTA may recognize the rights of each party to inventions developed exclusively and/or jointly. These rights may also impose future liabilities, financial expenses or participation in future patent grant procedures on the parties. In a CTA, the parties can also briefly discuss the terms of the licence negotiations. Since a CMA may receive federal funding and/or be designated as a not-for-profit organization, the CMA must ensure that it does not violate any laws or regulations to which it is subject. A CTA sets out the confidentiality obligations of the parties. It is very likely that the parties had already entered into a confidentiality agreement (ADC), and the CTA could reflect similar conditions. Therefore, like a CDA, the CTA defines what information is (or cannot) be confidential and under what circumstances the information may be used or disclosed to third parties. It is important to define what is confidential and what is not. For example, trade secrets are often included in the definition; However, the reality is that a trade secret is protected until it is disclosed or retro-conceived. .