One of the goals of the Brain Health Registry is to assist with recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies. We are eager to develop collaborations with other investigators who share the same goal of accelerating the development of improved diagnostic tests, effective treatments and preventative interventions for Alzheimer’s disease and other brain disorders.
One of the ways that the Brain Health Registry can help facilitate clinical research is through a SaaS (Software as a Service).
Please read the description and summary of steps below to help you to complete the SaaS Request Form.
BHR offers the use of its Software as a Service (SaaS) to help collaborators run and manage their own studies. BHR manages the software, such as backup, scaling, troubleshooting, and ongoing development; while collaborators can utilize the software's features to design, execute, and control their study.
Some of the basic features of BHR SaaS include:
- Personalization and custom design of the Participant Portal. The Participant Portal is the front-end view that can be displayed to participants when enrolling into a project supported by BHR SaaS.
- Participant registration which includes the ability to allow for self-registration or registration by invitation only. Upon registration, participants will create an account by designating a unique user name and password, which are used to login to the participant portal.
- Online consent form, which can be uploaded to outline the study in detail and describe the participant's role and rights in the study.
- Data collection, including the integration of study tasks such as questionnaires and cognitive tests (provided by 3rd party vendors), the customization of study design (such as layout of specified study tasks), and the implementation of longitudinal data collection.
- Participant communication, which can be configured as both HTML and Plain Text emails messages (ex. the creation of custom automated email reminders).
Some of the additional “Add-on” features of BHR SaaS include:
Referral program management, in which collaborators can establish and manage the referral of their study participants to specific future and/or additional research projects.
Spit Kit Management, allows investigators to track the mailing and receiving of spit kits (which can then be sent to an external third party lab for genetic analysis, including ApoE status).
The Caregiver and Study Partner Portal (CASPP) allows participants to have the opportunity to identify and invite a study partner.
Collaborating investigators obtain approval from their local Institutional Review Board (IRB) to use BHR software to design their own Internet-based studies. The collaborator will be completely responsible for running the project, contacting participants and collecting data. They will have complete control over study design including the ability to design their own landing page, questionnaires, cognitive tests, and participant communications.
All patient health information and data collected using BHR 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. The collaborator will determine if they wish to share de-identified data with the BHR team and have an academic partnership, but this will not be a requirement.
The BHR team will provide the following support in a BHR SaaS:
- Respond to general questions
- System bug fixes and/or troubleshooting that may arise with the use of the software
- Building out and sending a dataset (downloadable zip files containing a CSV) on a monthly basis
- Note: this does NOT include building out a database or integrating databases
- Currently, we only export all questionnaire responses and cognitive test data
- Assistance with creating participant communication emails
- Provide staff user support documentation & training on how to use the software
Operations of the software including:
- Initial configuration
- Monitoring of software performance
- Responding to outages and downtime
- Ensuring security of software
- Regular upgrades and releases new versions of software
The BHR team is NOT responsible for the following support in a BHR SaaS:
- Establishing relationships with 3rd Parties (non-UCSF entities whose software may be integrated into the BHR platform for data collection)
- Establishing Qualtrics accounts in order to use the questionnaire features available in BHR
- Configuration of collaborator's studies
- Running & maintenance of collaborator's studies
- Developing any new features or enhancements to features to the software
If you are interested in a SaaS, please complete the SaaS Request Form and return the completed form to BHR.
Summary of Steps:
1. Start-up (Initiation)
a) Download and complete the SaaS Request Form
b) Send the completed form to BHR (firstname.lastname@example.org) for review
2. Program Plan
a) Develop a scope of work including project objectives and timeline
b) Determine budget
3. Contractual Agreement
a) Execute a legal contractual agreement
b) Obtain third party approvals and/or relationships, if applicable
a) BHR will validate the initial configuration of the Collaborator's system prior to launch
b) BHR provides Collaborator Documentation and Training
5. Data Sets
a) Generate dataset and data dictionary
b) Provide dataset on predetermined schedule
6. Data Sets
a) Identify, report, and address any issues/bugs
b) Maintenance of software
Please note some steps may run concurrently to expedite process.