Thank you for your interest in the Brain Health Registry. The goal of BHR is to assist with recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies, including interventional randomized treatment trials and observational studies. Our aim is to accelerate the development of effective treatments and preventative interventions for Alzheimer’s disease and other brain disorders. By building well-characterized, trial-ready cohorts with longitudinal data, BHR can help significantly reduce the time and costs associated with recruitment for clinical trials and other research studies.
BHR is an observational study that aims to build an online registry while collecting extensive data from participants via self-reported online questionnaires and neuropsychological assessments. As a note, while the online self-report questionnaires are based on well-validated measures, the cognitive assessments are not yet validated and they should not be used for diagnostic purposes. Participants may also identify a study partner (SP), such as a family member or friend, to answer questionnaires about them. This study is led by Principal Investigator (PI) Michael Weiner, MD, and Co-Investigators Mackin, PhD, and Rachel Nosheny, PhD. BHR is overseen by the UCSF Institutional Review Board (IRB).
Brain Health Registry currently offers different methods in which we can help facilitate clinical research:
BHR allows and encourages sharing of the entire BHR de-identified database with qualified investigators and research teams. This is regulated by a Data Use Agreement (DUA), which requires collaborators to agree to terms including but not limited to:
• Compliance with any rules and regulations imposed by their institution and its IRB in requesting data
• Prohibits any attempt to identify or contact any BHR participants
• Prohibits distribution to a 3rd party or disclosure of data beyond the uses outlined in the agreement
BHR offers the use of its software to help collaborators run and manage their own studies. This software is available for collaborations of any type, and is run by the collaborator’s IRB. While BHR manages the software, such as backup, scaling, troubleshooting, and ongoing development, collaborators can enjoy features listed below, which will allow them to maintain control of their study.
Some features of SaaS include:
• Personalization and custom design of domain, as well as owning the look and feel
• Participant registration, including the ability to allow self-registration or registration by invitation only
• Online participation consent form
• Data collection, including the ability to view your custom study design, determine how often participants are returning, and the creation of custom automated email reminders
• A complete Study Partner Portal, which allows study partners of participants to login and register
• Participant communication, such as automated email reminders
• Referral management, in which collaborators can establish and manage their own referrals to sites
• Custom dashboards
Data collected using Brain Health Registry’s SaaS belongs to the collaborator. BHR staff does not have permission to access or use the data collected, unless explicitly granted through a Data Sharing Agreement. However, BHR can use the aggregate data for general metrics to evaluate usage and performance of the BHR platform. Additionally, individualized data may be accessed by the BHR Operations Team for the explicit purpose of debugging or troubleshooting.
BHR offers the ability for collaborators to invite and track their research participants by having them join BHR. The goal of co-enrollment is to link study data collected by both research studies to create a more enriched dataset for analysis, papers and presentations, and to inform participants of future research projects.
Collaborators may opt for a modified BHR experience in which their co-enrolled participants are given a subset of questionnaires and/or cognitive tests. Communication, visit frequency, and the look and feel of the BHR experience can also be customized.
Co-enrollment programs would function under both UCSF’s IRB and the Collaborator’s IRB.
DUE TO HIGH DEMAND, WE ARE CURRENLTY NOT TAKING ON ANY NEW REFERRAL PROGRAMS AT THIS TIME.
BHR offers two referral program options which are both conducted under UCSF’s IRB and the Collaborator’s IRB.
• Comprehensive Referral: A referral originating from the pool of participants already enrolled in BHR. These referrals have completed one or more visits containing self-report questionnaires and often cognitive tests allowing for a more comprehensive screening prior to site referral.
• Direct to Site Referral: A referral without the requirement to enroll in BHR and complete questionnaires/cognitive tests. These referrals will be referred directly to a site from either a web-based form or landing page.
Collaborators may also choose to add additional screening options to their referral program:
• Controlled Distribution: Referrals can be distributed to sites all at once or incrementally, determined by study or staff capacity needs. This can be useful for managing site burden, including periods of limited staffing or high demand. The distribution schedule can be dynamic and adjusted at any time.
• Prescreen: Prescreening participants is an additional tool that can help determine the most qualified candidates to a study. Additional screening for Comprehensive Referrals can be obtained with collaborator requested detailed questionnaires and/or cognitive data collected by BHR at one or more visits. This allows a study to use their inclusion/exclusion criteria and site location information to identify a potentially more suitable referral. Alternatively, Direct to Site Referrals can use a short online prescreen that allows for additional limited evaluation prior to referral.
If you are interested in collaborating with the Brain Health Registry, please email us at firstname.lastname@example.org and indicate which type of collaboration you are interested in.