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. A CTA must include the management of the publication and presentation of clinical data by the sponsor. 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. 9 Uncle Sam wants you….. To be compliant. The language of the contract must be consistent with the laws, rules, regulations and guidelines, requirements and procedures of the Florida hospital. First, let`s talk about a very important issue, compliance with existing laws and regulations.
The slide is quite self-explanatory, – we cannot agree to do something illegal, – we cannot agree to do something that goes against our research mission – we cannot accept a language incompatible with our statutes. To put it again, each contract must comply with federal and regional laws, rules and regulations, and FH guidelines, requirements and procedures. It also means that we have to accept realistic language. If a sponsor provides a language stating that not all research staff can work on medical trials or projects, we cannot realistically meet this requirement. We will not give any power to an external unit to tell us what we can and cannot study. 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. If a third party,. B for example, an experimental object, is negatively affected by the CTA located between the sponsor and the site, the sponsor will compensate for the loss and assume full responsibility.
In general, the purpose of a clinical study is to collect safety and efficacy data for a particular medical device. 16 When do I speak to 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. We are here to help you, help you and accompany you in this laborious task, to conclude an agreement with a sponsor, to comply with the guidelines of the FH and to protect your research and financial interests. 7 Sponsor Trading provides a template. FH Legal checks and comments on the document. Go back and forth with the sponsor until all points are covered. Put yourself on the “yes” vote.