Service Agreement Clinical Trials

First study. The proponent maintains CRO to provide certain services related to the study entitled [insert the name of the study, as mentioned in the minutes) (the “study”) in accordance with the minutes: [insert the protocol number] under review (as it is possible to change the “protocol” from time to time). Kunal Sampat, Senior Manager, Clinical Research, Abbott, explains the essential elements of a clinical trial agreement This section of the agreement is often overlooked by sponsors, CROs and sites. The purpose of this section is to explicitly state the description of the research project. You want to document the overall purpose of the agreement in this section. 8.1 Study behaviour. CRO performs the services of each PPI in accordance with the applicable provisions of each study protocol, agreed SOPs, current guidelines on clinical best practices for trials (“GCP guidelines”) and all applicable local guidelines, government and federal laws and regulations on the conduct of clinical investigations, including, but not limited, the Federal Food, Drug and Cosmetic Act and the Regulations of the Food and Drug Administration (“FDA”) and the Health Insurance Portability and Accountability Act 1996 (“HIPAA”) and Department of Health and Human Services (“HHS” rules. Whether you are new to clinical research contracts or a ninja contract, at any time, there is at least one agreement that you can imagine that one could have formulated otherwise. The proponent wishes to continue clinical trials of crenolanib (“study” or “trials”) that are subject to an applicable protocol (“protocol”). 12. Insurance. cro owns, at its sole cost and cost, the following insurance coverage rights: (a) general liability insurance with a limit of at least $5,000,000 per incident and $10,000,000 per year, which must include personal, personal and property damage; (b) auto and automobile liability insurance, with a cap of at least $300,000 per incident, whose coverage must include personal, personal and property damage; and (c) workers` compensation insurance, in accordance with current national compensation legislation.

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