We will ask you to provide some personal and health information, such as:
Your name, email address, telephone number, zip code
Your date of birth, gender, ethnic and racial background
Lifestyle information; health and medical history
Data resulting from your questionnaires
Data from your use of the app (e.g., date and timestamp of your progress through the app sessions)
You will also be asked to fill out an electronic medical records authorization form to give us permission to view your medical records. This will give us a better understanding of your cancer diagnosis and treatment and your general health status.
Your contact details will not be disclosed to anyone except a small number of people with direct responsibility for managing the study and will be treated as strictly confidential. The contact details you provide will be used only to communicate with you about the study and your participation, such as reminders to complete questionnaires.
Blue Note Therapeutics staff, regulatory agencies, review boards, and ethics committees (that approve and monitor studies), and others may check the study records. This is done to make sure that the study is being run properly. It may also be necessary to pass information that identifies you such as your name and date of birth to Blue Note Therapeutics if there is a serious safety risk. This information will only be shared between select members of the study Sponsor and delegate organizations who are responsible for safety monitoring of the study.
Your data will be de-identified for research, meaning personal identifiers (names, addresses, and other identifying information) are removed from the health information you provide (e.g., questionnaire responses and information from medical records). The information that pertains to you will be coded by a special study ID code, not your name. The link between ID codes and names will be kept separate from the de-identified dataset used for research. Your name will be used only when addressing you personally—for example, in a phone conversation with you. Within the application, there may also be places where you can choose to share your name or other identifying information.
Blue Note Therapeutics and other scientists and organizations use de-identified information to learn about diseases and medicines. It may be used for this study or other purposes, including future research. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medical devices. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data.
Your personal information will be used for only as long as needed for the study and future research, with your consent. It may be retained for longer, where required by law. Blue Note Therapeutics must retain data from clinical trials for up to 5 years. If you withdraw from the research, no new information will be collected, but information already in the database will remain with the study data.