2.20. Confidentiality
The results from this clinical trial are confidential and may not be transferred to third parties in any form or manner without written permission from the Sponsor. All individuals involved in the clinical trial are bound to this confidentiality clause in line with the Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, as well as all other valid and applicable laws and regulations, such as the “While obtaining a signature for the Written Informed Consent, the Investigator will request written permission from the patient to directly access his/her data. With this permission granted, the patient’s data may be examined, analyzed, verified, and reproduced for the evaluation of the clinical trial.Data will be anonymized, so that the corresponding patient cannot be identified. Patient data will also be dissociated. Patients will be assigned consecutive numbers as they are enrolled in the study, and these identification numbers (or codes) will be used in the eCRF; the full name of the patient will not be included in the eCRFs. The principal investigator of each center will keep an updated patient identification list containing the name, clinical history number and the patient’s identification number (or code) for the clinical trial.The study monitor may have access to the patient’s identity and data related to the study monitoring procedures. Any person with direct access to the data (Regulatory Authorities, Trial Monitors, and Auditors) will take all possible precautions to maintain the confidentiality of patient’s identities. It is the Investigator’s responsibility to obtain a written informed consent from the study patients. It is the Trial Monitor’s responsibility to make sure that each patient has given his/her written consent to allow this direct access.The Investigator shall ensure that the documents provided to the Sponsor do not contain the patient’s name or any identifiable data.