b.research mobile application (the “Application”)  

The b.research application has been developed by b.research team for The Company . « We », « us », or « our » refers to b.research team of The Company.  
This document explains how your information and Personal Data (defined below) will be collected, used, stored, and protected in accordance with the terms of this Privacy Notice and any applicable data protection and privacy legislation. By using the Service, you consent to the terms and conditions as set out in this Notice.  
When using this application, we can be qualified differently. We act as a Controller (responsible of the processing of your data) for all the processing strictly related to your usage of this application.  
We also act as a Processor under the instructions of its customers for all the data processed in the context of the clinical trial. In this regard, all information relating to the data processing has been provided to you in the Informed Consent form (ICF) and all your questions have been answered by the Principal Investigator or a Study team member before ICF signature. However, if some question remains, please refer to the clinical trial team for any questions related to these processing.  

This Notice therefore only provides information for Processing where we are Controller. 

1. INFORMATION WE COLLECT  

While using the Application, we may ask you to provide us with certain personally identifiable information (« Personal Data »). Personal Data means any information about an identified individual or an individual whose identity may be inferred or determined from such information. 

When you use the Application in the context of a clinical trial, information we collect may include, but is not limited to:  

  • Your patient ID provided by the Study team 
  • Your answers to the b.research application including Quality of Life Scale (QoL) questionnaires 
  • Others health data necessary for the monitoring of the study 
  • Patient’s diary (Medical appointments, Intercurrent events, medicine intake, measurements via connected devices (blood pressure, weight, blood glucose…) 
  • Date of completion of the questionnaires  

In the framework of the Application use we may also collect:  

  • Your gender and birth date 
  • Your personal e-mail address  
  • Your phone number 

Under certain circumstances we may be required to disclose Personal Data without your consent. Such circumstances may include, without limitation and subject to applicable laws:  

  • where use or disclosure of Personal Data is required by applicable law or by order or requirement of a court, administrative agency or governmental tribunal  
  • where the use or disclosure of Personal Data is reasonable for the purposes of investigating a breach of an agreement, or actual or suspected illegal activity  

2. WHO WILL ACCESS YOUR INFORMATION AND PERSONAL DATA AND HOW THEY WILL BE USED:  

  • b.research staff for activities related to maintenance of the b.research database and to perform data manipulation, including de-identification, and analysis  
  • The Company will only have access to data that can no longer allow to identify you directly or indirectly (aggregate Data) and may use such data for research purposes such as publications, communications… 
  • We will access the individual data for the following purposes:  
  • Detecting and addressing any technical or other issues with the Service; 
  • Updating, improving and maintaining the Service.  
  • We may use your e-mail address to inform you about updates of the Service, research projects you may be entitled to participate through the Service, or any other similar activity. We will limit the volume of these communications to the lowest possible level.  

The abovementioned data are processed under the T&Cs, the contract, you have agreed to for the use of this Application. 

We may also retain your information and Personal Data to comply with laws, prevent fraud, resolve disputes, troubleshoot problems, assist with any investigations, enforce our Terms of Use and take other actions otherwise permitted by law. We can do this on the basis of our legal obligation related to Clinical trials regulation (such as Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014) for medicinal product or regulation governing Medical Devices (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices). 

In all cases, the information will prevent direct identification of individual patients. Specifically, your e-mail address and user name will never be shared with any external entity, and will only be used to enhance your participation to the b.research project the Website and mobile app. The Company  may use your e-mail for communicating with you in relation to the b.research project.  

3. HOW LONG THE DATA WILL BE STORED 

The data is stored only for the period necessary to achieve the purposes for which it was collected (end of clinical trial or if you withdraw your consent) and to comply with applicable laws, rules, or regulations. 

The duration of the processing of data collected for the purpose of clinical trials is not established by us but is specified in the information provided to you by the Clinical Centre or the Sponsor or the CRO. 

4. HOW WE STORE AND PROTECT YOUR DATA  

Access to your Personal Data is limited, controlled, and managed to make sure that confidentiality is preserved. Maintaining your privacy and appropriate confidentiality is a top priority to us and strict security rules are in place to guarantee privacy is maintained at all times.  

Your information is kept on the b.research database which is physically located in a secure data centre, with appropriate physical, administrative and technical safeguards in place. These procedures protect your information from misuse, unauthorised access, interference, alteration, loss and/or disclosure.  

5. DATA TRANSFER  

Your information, including Personal Data, may be transmitted to – and maintained on – computers located outside of your state, province, country or other governmental jurisdiction, where the data protection laws may differ than those from your jurisdiction.  

If you are located outside E.U (European Union) and choose to use the Service, please note the data is sent to our servers in E.U.  

However, in case of a transfer of your personal data outside E.U., this will be carried out in one of the ways permitted by applicable data protection law, such as on the basis of Adequacy Decisions, through the adoption of Standard Contractual Clauses approved by the European Commission. 

6. YOUR RIGHTS TO ACCESS AND CONTROL YOUR PERSONAL DATA  

In accordance with the European regulations in force, the users of b.research application have the following rights: 

  • right of access to your personal data and information that is subject to processing. You also have the right to request a copy of all information held about you  
  • right to rectification you can request the correction or updating of your data;  
  • right to block or erase Users’ personal data when data is inaccurate, incomplete, ambiguous, out of date, or whose collection, use, communication or storage is prohibited; 
  • right to withdraw consent at any time; 
  • right to restriction of processing of Users’ data; 
  • right to object to processing of Users’ data; 
  • right to the portability of the data provided by the Users, when the data is subject to automated processing based on the Users consent or on a contract; 
  • right to determine the treatment of Users’ data after their death and to choose to which third Party, which the User will have previously designated, The Company will communicate (or not) the said data. 

If the users wish to exercise their rights or to know how The Company uses their Personal Data, the Users can contact The Company DPO by e-mail at DPO@banookgroup.com  

or in writing at the following address: 
The Company, Sécurité des données, 84 Avenue du XXieme Corps, 54000 Nancy, France.  

In this case, the users must indicate the Personal Data that he or she would like The Company  to correct, update or delete, identifying himself or herself precisely with a copy of an identity document (valid identity card or passport). 
Requests for the deletion of Personal Data will be subject to the obligations imposed on The Company  by law, in particular with regards to the conservation or archiving of documents. Finally, users of b.research application may file a complaint with the competent data protection authorities of their habitual residence, place of work or place of alleged infringement (link to EU data protection authorities), and in particular with the CNIL. 

7. CHANGES TO THIS PRIVACY NOTICE 

This Privacy Notice is effective as of 18th October 2022 and will remain in effect except with respect to any changes in its provisions in the future, which will be in effect immediately after being posted on this page.  

We reserve the right to update or change our Privacy Notice at any time. If so, we will notify you through a notice on the App home page or other appropriate means of communication. b.research/The Company  is committed to assessing, reviewing and updating this Privacy Notice on a case by case basis to meet any changes in regulatory requirements in applicable jurisdictions. Your continued use of the Service after we post any modifications to the Privacy Notice on this page will constitute your acknowledgment of the modifications and your consent to abide and be bound by the modified Privacy Notice.  

8. CONTACT US  

If you have any questions about this privacy Notice, please contact us at: DPO@banookgroup.com   

Last update on 11SEPT2024 

Version: 1.2