Ccmo Directive On The Assessment Of Clinical Trial Agreements
The Directive will enter into force on 1 January 2009. As of that date, ethics committees will verify the compliance of clinical trial agreements with the CCMO Directive. This clinical study is being conducted at multiple sites under existing niaid-sponsored contracts and grants. NIAID will act as a sponsor of Investigational New Drug Application (IND). NIAID contractors, fellows, research networks, clinical research institutes or their auditors are not parties to this Agreement. For this reason, the CCMO has decided to set conditions concerning: (i) the provisions contained in the agreements for the early termination of research and (ii) the provisions relating to the disclosure of research results. The CCMO wants to prevent independent publication of negative research results from being blocked by one of the two parties involved, although delays are .B remains possible for patent reasons. In addition, the possibilities for early termination of research are limited and subject to strict rules. Contracts can no longer be terminated prematurely, for example. B due to the mere decrease in the sponsor`s (commercial) interest in the research results. The Dutch CENTRAL COMMITTEE for Medical Research in Humans (CCMO) has drawn up a directive on the evaluation of agreements on clinical traces. Companies may need to adapt their (presentation) agreements on clinical trials accordingly. This model agreement for clinical trials is established in collaboration between the vereniging of the topclinic opleidingsZiekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON in order to facilitate the conduct of clinical trials in the Netherlands.
The termination and publication clauses are consistent with the CCMO Clinical Trials Agreement Evaluation Directive. To easily find the competent authority for the registration of clinical trials, there is an online tool called Committee Finder. The Committee Finder has been updated based on changes to the procedure for registering a clinical trial with a medical device. The content of the application procedure will not change at this stage. Accordingly, clinical trials of medical devices must be registered before the start of the examination. The objective of clinical trials is to verify the performance of products in accordance with the requirements and to determine adverse reactions under normal conditions of use. The final goal is to obtain the CE marking. The clinical trial on a medical device already bearing the CE marking must be registered even if the purpose of the study is outside the scope of the use of the medical device (i.e. a new indication). In addition, the obligation to register with the CCMO also involves the reporting of serious adverse events (SXAs) and the reporting of the end or premature end of the study. The declaration of registration must include, inter alia, the identification data of the medical device, the investigation plan and the declaration that the product meets the essential requirements.
After May 26, 2021, changes will be made to the documents to be provided. From 1 October 2020, medical device manufacturers will have to register clinical trials with the Dutch Central Committee for Human Research (CCMO). Until now, the competent authority for this task has been the Health and Youth Inspectorate (IGJ). The fact that manufacturers must now register with the CCMO is due to the amendment to the Medical Devices Regulation (MDR), which will come into force on 26 May 2021. In order to avoid confusing situations, it was decided to transfer the registration procedure from the IGJ to the CCMO before 26 May 2021. . .