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Article History

Received: 1 May 2021

Accepted: 13 July 2022

First Online: 13 August 2022

Declarations

:

: All procedures performed in this study, which involves human participants, will be in accordance with the ethical standards of the Helsinki declaration 1964 and its later amendments or comparable ethical standards. The study poses minimal risk for the participants. The anonymized information collected in the study will be used for research and publication purposes, and always safeguarding the right of privacy and anonymity according to the rules of General Data Protection Regulation (GDPR) of the European Union (EU) 2016/679. Prior to the commencement of the study at Miguel Servet University Hospital, the protocol has been submitted together with its associated documents (information sheet for the patient and informed consent form) to the CEICA (Aragonese Ethical Committee for Clinical Research). In this regard, a written favorable opinion/approval of the CEICA has been obtained. The subject’s written informed consent to participate in the study must be given before any study-related activities are carried out. However, in order to comply with local regulations, for 12 years old children and over, an additional consent will also be mandatory. The ICF must be signed and personally dated by the subject and the site investigator (or designee at the Miguel Servet Hospital). The signed and dated declaration of informed consent will remain at the investigator’s site and must be safely archived by the investigator. A copy of the signed and dated information and consent form will be provided to the subject prior to participation. Adequate information must therefore be given to the subject by the study site investigator or a member of his team before informed consent is obtained. In addition to providing this written information to a potential subject, the investigator or his/her designee will inform the subject verbally of all pertinent aspects of the study<i> (the language used in doing so must be chosen so that the information can be fully and readily understood by laypersons)</i>. According to national regulations in Spain, a designated person by the investigator may inform the subject and sign the Informed Consent Form. To ensure that participants’ anonymity is maintained during the study, a coding system will be used so that a unique code-number will be assigned to each participant at inclusion. This number will also be used as a subject-case identifier in the data sets of the study. On the CRFs or other documents subjects will not be identified by their names, but by their assigned identification numbers. The clinical investigator at the hospital will keep a separate log of subjects’ identification numbers, names, addresses, telephone numbers, and hospital numbers. Documents not for submission to the Sponsor, such as signed Informed Consent Forms, will be maintained in strict confidence by the investigator. Only authorized persons will have access to identifiable personal details if required for data verification. The subject’s original medical data that are reviewed at the site during source data verification by the audits, and Health Authority inspections will be kept strictly confidential. The investigator agrees to provide direct access to these documents to the Sponsor and Health Authority representatives. The investigator is responsible for retrieving information from personal medical records. Data protection and privacy regulations will be observed in capturing, forwarding, processing, and storing subject data. Subjects will be informed accordingly and will be requested to give their consent on data handling procedures in accordance with national regulations.

: Not applicable.

: LFL, SCT, FJNB and IACG are employee of Adhera Health Inc., which is a Precision Digital Companion™ company based in Palo Alto (CA, USA). LFL is a shareholder of Adhera Health Inc.