Of course, this is a broad topic, but these are five legal pitfalls of clinical study agreements: clinical trials necessarily involve the collection and subsequent use of large amounts of sensitive personal data, and voluntary consent of patients is required to participate in such studies. Readers will know that the introduction of the 2016/679 General Data Protection Regulation (“RGPD”) requires organizations to have robust procedures for the use of personal data. This means that clinical trial participants have access to their data and receive information about how it is used and stored. In fact, data on clinical trial participants should be made anonymous, in which case the RGPD will not apply. Nevertheless, there are ethical considerations that must be respected and, therefore, the processing of personal data is quite similar: subscribers should be informed of how their data is used, even if, from a technical point of view, it is not considered “personal data”. Such issues will already be familiar to practitioners discussing ATCs, where ethical considerations and the protection of volunteers have always been the first. It should be remembered, however, that the position should be considered on a case-by-case basis and even on a case-by-case basis. In fact, there may be several categories of mental protection in mental development – those relating to the product being studied, which relates to the clinical procedure and possible improvements to the existing investigation period. Again, the parties should consider the licenses that may be required to deal with the use of such a leading IP. CDAs differ from most trade agreements in that the intellectual property produced (IP) is generally data that can be submitted to a regulatory authority to obtain marketing authorization for the drug in question. In most cases, they are unlikely to lead to potentially patentable issues, but the investigative period remains of the utmost importance in these agreements. Research in an institute is led not only by the Institutional Review Board (IRB), but also by the legal agreement between sponsors and the institution.
Institutions should, ultimately, ensure that judicial procedures are properly applied. Therefore, the CSA should describe the role of the party in the design and conduct of testing, access to data and publication obligation, including publication rights and liability. The International Committee of Medical Journal Editors (ICMJE) has revised its “Uniform Requirements for Manuscripts presented in Biomedical Journals” to maintain the unsableness of research and publication6.