All data will be kept according to the current data protection legislation applicable in your country of residence, including the General Data Protection Regulation (EU) 2016/679 (“GDPR”). All information about you and your health will be kept private. The only people allowed to review the data and information you provide will be the research team, the Sponsor (Ad Scientiam), service providers for the trial and the regulatory authorities who check that the trial is being carried out correctly.
Ad Scientiam will work with Alexion Pharmaceuticals, Inc (“Alexion”) to support the study; as such, Alexion and Ad Scientiam 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:
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: meandmgopen@lindushealth.com. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to Lindus Health’s Data Protection Officer (data@lindushealth.com) should be first relayed to the 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: meandmgopen@lindushealth.com. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to Lindus Health’s Data Protection Officer (data@lindushealth.com) should be first relayed to the Investigator, if at all possible.
Which data will be collected?
If you agree to participate in the study, the following data will be collected:
The following data will be collected in order to compensate you for your participation:
If you would like more information about the personal data collected, please access our website privacy policy: https://www.meandmgopen.com/privacy-policy. You may also contact the Investigator at: meandmgopen@lindushealth.com. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to Lindus Health’s Data Protection Officer (data@lindushealth.com) should be first relayed to the Investigator, if at all possible.
Data protection regulation requires that we state the legal basis for processing information about you. All the data collected will be stored in two distinct databases (e-CRF and ME&MGopen), administered and managed by Ad Scientiam and Lindus Health. Your data will be source-coded using a tokenization system, i.e., one unique token per participant will be generated at the beginning of the study. The Sponsor, Ad Scientiam, will complete the statistical analysis for this trial. Your data will be used and stored in accordance with General Data Protection Regulation (GDPR) and HIPAA.
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.
Lindus Health will retain the correspondence table between your personal data and your identity for 15 years after the termination of the study to comply with legal obligations.
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.
If you are looking for more information on how we process your Research Personal Data including on data security, data retention and lawful processing bases, please access our website privacy policy: https://www.meandmgopen.com/privacy-policy
Please read this privacy notice carefully as it provides important information about how we handle your personal information and your rights. If you have any questions about any aspect of this privacy notice you can contact us using the information provided below or by emailing us at: meandmgopen@lindushealth.com
Results will be published in scientific journals, presented at scientific conferences, and might be published on the Ad Scientiam, Alexion and Lindus Health websites, and may be shared with study participants, with pharmaceutical partners and/or reported in news media. You will not be provided with the data that you enter as part of the app or e-questionnaires. No personal identifiable data will be published and it will not be possible to identify you in any report, publication or presentation.
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), Health Canada, 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 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.
If you have questions, concerns or would like to offer input about the study, you can contact the researchers at meandmgopen@lindushealth.com.
If you want Lindus Health to stop processing your data as indicated above, you can withdraw your consent at any time by contacting Lindus Health, The Leather Market, Weston Street, Bermondsey, London, SE1 3ER. Alternatively, you can email Lindus Health at data@lindushealth.com. This will likely require you to withdraw from any ongoing research. For more information about how Lindus Health uses your personal data, please see the Lindus Health Privacy Policy.
For US Participants: You may contact Salus IRB if you:
Salus IRB
Phone: 855-300-0815
Email: subject@salusirb.com
Reference #: 23034
For Canadian Participants:This study has been reviewed by Veritas Independent Review Board (IRB). If you have any questions about your rights as a research participant or the Investigator’s responsibilities, you may contact the Manager of Veritas IRB 24 hours per day and 7 days per week at 514-337-0442 or toll-free at 1-866-384-4221. An IRB is a group of scientific and nonscientific individuals who perform the initial and ongoing ethical review of the research study with the subject’s rights and welfare in mind. If you have any study-related comments, complaints or concerns, you should first contact the study investigator. Please call the IRB if you need to speak to a person independent from the Investigator and the research staff, and/or if the Investigator and the research staff could not be reached
If you decide to take part, you can still withdraw at any time without giving a reason. Information collected up to that point will still be used. If you wish to withdraw from the trial, please contact the Lindus Research Team using the contact details at the end of this document.
There is a possibility that your participation may be terminated at the discretion of the investigator/study staff.
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, please access our website privacy policy: https://www.meandmgopen.com/privacy-policy. You may also contact the Investigator at: meandmgopen@lindushealth.com. In order to maintain your confidentiality to the Sponsor, comments, communications, and complaints addressed to Lindus Health’s Data Protection Officer (data@lindushealth.com) should be first relayed to the 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.
