Publication of the results. The SPONSOR undertakes to publish the results of this CLINICAL RESEARCH with medical device. It will be obligatory to send this publication to the CRECs involved in the conduct of the CLINICAL RESEARCH with medical device and to the Principal Investigators for their reference. The PRINCIPAL INVESTIGATOR will be able to present the results at an appropriate scientific meeting and/or to publish them in a prestigious and renowned journal, undertaking to supply the SPONSOR with a copy or original version of the manuscript, with sufficient advance notice so that they have an opportunity to review the information or informational material and provide their comments regarding the content of the media/publications within 30 days counting from receipt thereof. The PRINCIPAL INVESTIGATOR undertakes to respect the agreements established in the Protocol of the CLINICAL RESEARCH with medical device, which make particular reference to the publication of the data, avoiding communicating the data for one site and always presenting the CLINICAL RESEARCH with medical device data as a whole. If the SPONSOR requests it, with the aim of appropriately ensuring the protection of inventions or developments derived from the CLINICAL RESEARCH with medical device, the PRINCIPAL INVESTIGATOR shall agree to present the proposed publication within a maximum term of 6 months. The SPONSOR undertakes not to prevent and/or impede the dissemination of any set of results that, being scientifically solid and unquestionable highlights the absence of efficacy or adverse effects of the treatment. The SPONSOR is obliged to fully comply with article 42 of the publications of Royal Decree 1090 of December 4, 2015, regulating clinical trials with medicines. If 9 months have passed since dissemination of the final report of the CLINICAL RESEARCH with medical device to the relevant authorities, in compliance with article 19 and 30 of Royal Decree 1090 of December 4, 2015 for the performance of clinical trials with medicines, and the SPONSOR has not approved the global publication, the results can be made public in the Network of Research with Medicines and Health Products of the Community of Valencia (REDIMEPS) 2.8.- Confidentiality and Data Protection All of the information supplied or obtained in relation to the conduct of the CLINICAL RESEARCH with medical device, either before or after the CLINICAL RESEARCH with medical device, is confidential. If, in any event, the information is revealed to a th...
