Clinical Trials Agreement Traduction

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. During the negotiation of the clinical trial contract, academic institutions focus on ensuring acceptable clauses on high-risk issues such as: Clinical study agreements treated in this office have all the following characteristics: a sponsored project involves negotiating, verifying and implementing legal agreements from external funding sources. Coordination between all parties, including the auditor and the external source of funding, is essential to ensure the success of the contract with mutually acceptable terms. Academic institutions have guidelines and regulations that define what can and cannot be accepted in a clinical study contract. The policy focuses on the protection of participants as research themes and minimizes the responsibility associated with human research. Private not-for-profit sponsors are motivated differently from a university institution. This may result in differences in principles and ideals, leading to longer contract negotiations before reaching an agreement acceptable to both parties. The agreement (CTA) is also known as a clinical study agreement or clinical research agreement. This is a contract between a university institution and another party about a clinical trial or study. 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.

Pharmaceutical companies generally fund clinical study projects to study drugs and devices and play an important role in ensuring product safety. The company also obtains approval from the Food and Drug Administration (FDA) and puts the drug or device on the market. Clinical trial contracts negotiate confidentiality and service agreements directly related to industry-funded clinical trial agreements.

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