PandaTip: This section of the model clearly defines the process of cancelling the clinical trial agreement. All other products and documents are the property of the institution and remain so after the completion and duration of the procedure. The study begins after the contract is approved and ends either with the termination of the contract or the end of the study. The institution conducts the following clinical trial: when the Clinical Trials Agreement is revised, an accredited ethics committee for medical research (MREC) and the CCMO will follow the CCMO Directive on the Evaluation of Clinical Trial Agreements. The directive applies to research within the scope of the WMO and where there is a written agreement between the parties to fund, organize and conduct the research. The institution reimburses all parties for all costs and costs related to the trial period during or after the trial period. All services performed by the sponsor remain the property of the sponsor, both during and after the end of the trial. New inventions or discoveries, which are developed exclusively by experimentation, are considered royalties and are made available to all participating parties as such. This model of agreement for clinical trials is established in collaboration between the vereniging seed plants Topklinische opleidingsZiekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON to facilitate the completion of clinical trials in the Netherlands. The termination and publication clauses are in line with the CMO`s Clinical Trials Agreement Assessment Directive.
The Early Feasibility Study (EFS) model was presented by the Medical Device Innovation Consortium (“MDIC”) as an educational tool. It is not designed as legal advice and should not be considered. The applicable laws may vary from state to state. Federal and regional laws for clinical trials are also subject to different changes and interpretations by courts in different jurisdictions. Each institution and sponsor that enters into a clinical study agreement should consult its own advisor for legal advice on clinical trial contracts. The institution is in no way responsible for the completion or delay of the clinical trial due to circumstances beyond the influence of the organ, civil unrest, divine acts or any other intervention.