Clinical Trial support and agreements
In scientific research, there is a growing focus on the market, which is increasing the pressure on scientists. The AUMC strives to create an environment in which it is possible to practice science independently and critically. It not only aims to promote high-quality academic research, but also enforce a scientific culture in which researchers conduct research ethically and honestly. Legal Research Support (LRS) advises researchers on contracting in medical research. This includes the review, drafting and negotiation of research related contracts related to clinical trials and/or health law, such as: Clinical Trial Agreements, Study Support Agreements and Site agreements.
The most common agreement is what is known as the Clinical Trial Agreement (CTA). This agreement forms a basis for medical research initiated by researchers at the AUMC (“investigator-initiated”) or by external sponsors from the pharmaceutical industry or research institutes (“sponsor-initiated”). Site Agreements are used when there is collaboration on research with other hospitals. Important components of this agreement include insurance, privacy protection, termination, liability and publication.
Please see the website of the CCMO for the different types of Clinical Trial Agreements (industry initiated, investigator initiated, with and without VGO). LRS will assist you with the drafting, review and negotiation of those Clinical Trial Agreements.
For information about the ethical review of clinical trials click here.