Clinical Trial Agreement Traduction


    In developing and negotiating a CTA, it is essential that the parties have a thorough knowledge of relevant laws and regulations that may impose additional requirements on them, although the laws and regulations are not reflected in the ATC. In addition, parties must be aware of and comply with internal policies and procedures to which they must comply. Because each study is unique, each CTA must be negotiated individually, although there are some common key elements in all ATCs. While this is not limited to the above, the following elements may be of the utmost importance in a CTA, particularly where a CMA is the part that conducts the clinical trial. The contract does not need to be written in legal form. In order to ensure that all parties have a clear understanding of the definitions of legal concepts, the treaty should be written in clear language. The tasks, results and responsibilities of the test site must be clearly written and detailed to avoid confusion as to what is necessary to carry out the study. When do the responsibilities of the parties begin and stop? From notification of adverse events to inventions, from the transmission of regulatory communications to reports, from the termination of the agreement to the publication proposal, from the safeguarding of confidential information to restitution, from billing to payment, the agreement is full of deadlines that govern the liability of the parties. It is therefore important to negotiate realistic deadlines. Failure to meet the deadlines in the agreement may result in non-payment or violation of the agreement. A CTA defines the confidentiality obligations of the parties. It is very likely that the parties have previously entered into a Confidentiality Agreement (CDA) and the CTA may reflect similar conditions.

    Thus, like a CDA, the CTA will define confidential information (or not) and the circumstances under which the information can 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; But the reality is that a trade secret is protected until it is disclosed or reissued. Therefore, a trade secret should not be included as confidential information. In addition, the CTA should determine the duration of the confidentiality obligation and what happens to tangible confidential information after the conclusion or end of the clinical trial. In a CTA, it is essential to identify the party with which the CMA negotiates. This may sound strange, but it is important to ensure that the party is a legal entity or that it is entitled to act on behalf of the sponsor in the case of a CRO. In addition, the company`s ID and address should be displayed in the agreement. The person signing the agreement must be an empowered representative who can legally compel that entity to fulfill the obligations set out in the agreement. It is also important to identify the lead investigator (IP) responsible for conducting the study and to find out if IP is an employee of the organization. Otherwise, IP may be considered an additional part of the CTA with personal obligations arising from the CTA.

    It is important that all parties understand the language used in the treaty. When the agreement is revised, capitalized terms, restrictive words and words that are not understood are sought. The contract should have a definition section. A clinical trial contract initiated by the investigator is required when an industrial sponsor provides the device or drug to be examined and/or the necessary funding for the study. A court decision or even a designation in an action can ruin a company`s reputation or financial situation.