Privacy Notice

This Privacy Policy applies to the personal data that we process as part of the proposed study. At Ad Scientiam, we respect your privacy and want to inform you about the processing of your personal data while allowing you to exercise your rights. The purpose of this Privacy Policy is to inform you of the personal data we collect, the purposes for which we process it, the length of time we keep your personal data, and your privacy rights.

Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

The objective of this study is to validate the performance and safety of the mobile application to measure symptoms at home, compared to the evaluation carried out at the hospital with your doctor. The study will also assess the ease of use of the tool as well as your satisfaction with the use of the mobile application.

The processing of your personal data is governed by the General Data Protection Regulation (EU) 2016/679 (“GDPR”) and by the laws applicable in your country of residence.

Sponsor will work with Alexion Pharmaceuticals, Inc (“Alexion”) to support the study; as such, Alexion and Sponsor are Joint Controllers of your personal data. If you agree to participate in the study, certain personal information about you will be collected, stored, processed, and used by:

• Ad Scientiam, Sponsor of the clinical study, acting as “Data Controller” and located in France.
• Alexion, its affiliates or other third parties designated by Alexion. to collect or review study data, acting as “Data Controller” and located in the United States.
• Popsicube, its partners and affiliates, a Clinical Research Organization in charge of the organization of the clinical study, acting as “Data Processor” and located in the European Union.
• Services providers, providing services related to the organization of clinical studies, data hosting and the compensation of participants, acting as “Data Processor(s)” located in the European Union, the United Kingdom and the United States.
• Investigators, Investigating sites and staff, for the conduct of the study, acting as “Data Processor(s)”, located in the European Union and the United States.
• The Institutional Review Board/ Ethics Committee that oversees the research study at your site.
• Government regulatory agencies including US Food and Drug Administration, European Medical Agency, Therapeutic Goods Administration, Health Canada, and other Regulatory Authorities worldwide.

The legal basis selected by the Data Controllers is the pursuit of legitimate interests. Study data, including your coded medical information, may be processed, which means it will be collected, entered into computer databases, stored, accessed, verified, analyzed, transferred, printed and reported as necessary for legitimate scientific purposes, including use in future medical or pharmaceutical research. This processing is authorized because it is necessary for scientific research purposes. The Data Controllers must implement appropriate measures to guarantee your rights and freedoms, including the collection of only strictly necessary data for research purposes. If you have any question on the legal basis for the processing of your personal data, you may contact the Investigator at the number(s) listed at the beginning of this document. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to the Sponsor’s Data Protection Officer (privacy@adscientiam.com) should be first relayed to Investigator, if at all possible.

Where applicable, the data transfer is made pursuant to an adequacy decision of the European Commission (art 45 of the GDPR) or appropriate safeguards such as contractual clauses between the Data Controllers and/or Data Processors (art 46 of the GDPR). By participating in this study, your personal data will be transferred in the European Union, the United Kingdom and the United States. If you would like more information about the transfer of your personal data, you may contact the Investigator at the number(s) listed at the beginning of this document. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to the Sponsor’s Data Protection Officer (privacy@adscientiam.com) should be first relayed to Investigator, if at all possible.

If you agree to participate in the study, the following data will be collected:

• Socio-demographic data (month and year of birth, sex, country, family situation, level of education, socio-professional category, professional life),
• Clinical data (weight, height, therapy followed in the context of the research, concomitant therapy, test results, adverse events, personal or family history, diseases or associated events, health status likely to influence the results or to make participation impossible due to medical contraindications, tobacco/alcohol/drug consumption),
• NMOSDCopilotTM digital tests and questionnaires’ raw data (timestamp, sensory sensors, accelerometer, gyroscope, relative position, voice sound, face image, user responses to questions about validity and order of hand, eye and contextualization for evaluation), and questionnaires (user responses to the various application questionnaires)
• NMOSDCopilotTM digital tests and questionnaires’ metadata (start date, completion of the test of questionnaire, exit reason etc.)
• Data that is created or collected from you during your participation in the study, including the dates of treatments and visits, participation in other ongoing studies, travel to the care facility, lifestyle and behaviors, reimbursement of expenses incurred by the person concerned related to the research, results of the tests above and any other procedures performed during the study.

The following data will be collected in order to compensate you for your participation:

• First and last name, date of birth, e-mail address, billing address, shipping address (for delivery of plastic cards, if applicable), cellphone number, IP address, IBAN (optional, if the user makes a transfer to his account), identification number in the clinical study, follow-up of the participation in the clinical study, follow-up of the realization of the study visits, expenses to be reimbursed with their justifications.

If you would like more information about the personal data collected, you may contact the Investigator at the number(s) listed at the beginning of this document. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to the Sponsor’s Data Protection Officer (privacy@adscientiam.com) should be first relayed to Investigator, if at all possible.

This informed consent form and the personal information collected as a part of this study will be kept until 2 years after the publication of the final study report, unless legal retention requirements force the Data Controllers and/or their Data Processors to keep the data for a longer retention period.

After this 2 years period, your personal data will be archived by the Sponsor and/or Data Controllers for twenty-five (25) years after the study has ended, in accordance with applicable regulations.

Your personal data will be archived by the Investigators, Investigating sites and staff for fifteen (15) years after the study has ended, in accordance with applicable regulations.

After this delay, your personal data will be securely deleted or anonymized, for example it can be used in a non-identifiable way for statistical analysis and business planning.

The results of the research may be presented at scientific meetings or in publications; however, your identity will not be disclosed.

You will provide personal information as a result of participating in this study, leading to a slight risk of loss of confidentiality. Every effort will be made to protect this information from disclosure. However, the U.S. Food and Drug Administration (FDA) and other regulatory offices may inspect study records. At the initial session you will be assigned a unique participant number that will be used throughout the study. Your personal identity will not be revealed in publications that may result from this study, nor will your name be used in other research communications such as lectures at scientific meetings. Experimental data as well as personal information will be kept securely by the Investigators and will not be released in any way that could be identified with you personally. Only summary statistics such as your age and gender will be included in published experimental results. This consent form, as well as any form which contains your personal contact information, will be stored in a location accessible only to the Site Investigator or approved designee.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Participation in this study is entirely voluntary. You may choose not to take part or may leave the study at any time. Refusing to take part or leaving the study will not result in any penalty or loss of benefits to which you are otherwise entitled. If you change your mind at any time, you are free to end the session and to withdraw from the study. Your decision of whether or not to participate in this study will not affect the quality of the medical care you receive at this facility. You may take as much time as you need to make up your mind if you will participate.

Your decision regarding the processing of your personal data will not result in any harm. You may withdraw your consent to the processing of your personal data at any time without justification and without consequence. If you choose not to consent or to withdraw your consent to the collection, access, use, storage, disclosure, and transfer of your data, you will not be able to participate in the study, as your data is needed to conduct the study. If you revoke your consent, your participation in the study will end with the completion of the Early Termination/End of study visit(s) and the study personnel will not collect any new medical information from you.

You have the right to access your personal data, the right to rectify inaccurate data , the right to be forgotten allowing you to request the deletion of your personal data, the right to restrict the processing of your data, and the right to object, at any time, to the processing of your personal data as permitted under your country’s applicable data protection laws and laws related to the conduct of clinical trials.

To exercise these rights or if you have any questions about the processing of your data, you can contact the Investigator at the number(s) listed at the beginning of this document. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to the Sponsor’s Data Protection Officer (privacy@adscientiam.com) should be first relayed to Investigator, if at all possible.

In accordance with Article 77 of the GDPR, if you believe, after contacting us, that your rights are not being respected, you have the right to lodge a complaint with the privacy or data protection regulator in your country of residence.