What Are Clinical Trial Agreements

Human volunteers are involved in clinical trials. The consequences, if things go wrong, can be catastrophic (many readers will remember the TGN1412 process, also known in 2006 as the Northwick Park “Elephant Man process”). It is therefore essential that any agreement relates to debts and determines who is liable in the event of default and that appropriate insurance rules are made. CTA models, which are often used in the UK, correspond to the current regulatory system. Practitioners should therefore ensure that proposals are updated with the new legislation as soon as they enter into force. However, the question on everyone`s lips is how Brexit will affect the regulatory framework. The issues raised by Brexit are beyond the scope of this article, but it is safe to say that there are real concerns within the medical research community that, regardless of the timing and mechanism of the UK`s withdrawal from the EU, if the UK does not adapt to the EU regime after Brexit, it will be a much less attractive prospect for clinical trials and scientific advances. This type of agreement can be initiated by a sponsor or investigator. A sponsor-initiated clinical trial agreement is required if funding is provided for the drug or device being served. Studies conducted in accordance with FDA regulations require a contract between the study site and the sponsor or organization of the clinical trial. The site may realize that a study requires more work than they expected…