Clinical Trial Agreement Between Sponsor And Cro
Sponsors undertake to declare the results of the study for ethical reasons. In contrast, clinicians are excited about the idea of publishing research data. The sponsor generally needs the absolute intellectual property established during the clinical trial or resulting from the clinical trial. In order to avoid future intellectual property issues, it is important to require the site to ensure that any IP it creates or owns does not violate (or violate) an IP address belonging to a third party. The payment terms and schedule also indicate what the search is not paid for. For example, for a post-authorisation clinical trial, the sponsor may not want to make the medical device available free of charge. Insurance is a no-brainer for sponsors and CROs. However, this is not always the case for websites and PIs, as professional liability insurance is not always applicable in some countries or regions. Intellectual property (IP) (such as data, documents, know-how, inventions, etc.) with respect to clinical trials can sometimes be difficult to negotiate. Both the sponsor and the website will want to use the IP resulting from the conduct of the clinical trial. What is often agreed upon is that the site has rights to the background IP to which it contributes, while the sponsor has full license rights to use that background IP to market the study drug.
The termination rights of all parties to CTA must be managed against the fact that clinical trials can be interrupted at any time for various reasons. It is preferable that compensation (and all applicable remuneration guidelines) be part of the CTA. Some countries and sites may have a secondary letter form setting out patient compensation. In any case, the availability and extent of the compensation that the sponsor ultimately grants to patients participating in the clinical trial must be clear to all parties to the CTA – and, of course, to the patients themselves through the declaration of consent. In Asia, it is important to note that some domestic sites (including Hong Kong) may not agree on CTAS with CRS, as they require an agreement directly with a sponsor, although a CRO has been appointed to manage the study on behalf of the sponsor. . . .