Websites want to be paid for their search results. In the case of a multi-year clinical trial, sponsors and CROs intend to manage their budget and cost estimates for current and future years. When should I contact FH Legal? As soon as the sponsor contacts you about an agreement, contact ORA. All requests for contract review must come from the ORA. Send requests to ORA via IRBnet with the corresponding documents. If one of the parties decides to take legal action, this agreement defines the jurisdiction under which the case is handled. 1 Clinical Study Agreements From the Legal Department of DeFlorida Hospital This presentation is intended to describe and explain the process of negotiating clinical study agreements with industry sponsors. This section of the agreement is often overlooked by sponsors, CROs and websites. 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. 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. In general, the purpose of a clinical study is to collect safety and efficacy data for a particular medical device.
15 Who negotiates contracts for my department? FH Legal negotiates all contracts for all FH research groups. FH Legal supports the ORA and research groups to understand the legal requirements and obligations of each study. FH Legal collaborates with the sponsor for the review of contracts and uses as the basis of previous contracts, models and framework contracts with each sponsor. FH Legal supports, supports and supports research groups in the laborious task of agreeing with a sponsor, respecting institutional policies and protecting your research and financial interests. Other types of agreements – Confidential Disclosure Agreements/Non-Disclosure Agreements (CDA/NDA) – Agreements to ensure the confidentiality of proprietary data that the proponent makes available to the investigator to decide whether he/she will participate in the study/research. FH requires the FH to be involved in all CDAs that in any way include the FH. Depending on the circumstances, the CDA will either be between a sponsor and the FH or a sponsor, the FH and the lead investigator. 14 Reading the responsibility of the CTA`s senior controller in a CTA. As the Legal FH reviews and negotiates agreements for research groups, it is very important that the lead investigator review the agreement to ensure that he is aware of the responsibilities he has demanded in a study and that he accepts the agreed terms.