001_SOW_241105_GL_.docx

STATEMENT OF WORK—CIRM Clinical Trial Data Infrastructure (Phase I)

1. Introduction The California Institute for Regenerative Medicine (CIRM) is dedicated to advancing the state’s capabilities in regenerative medicine through its support of clinical trials and innovations. CIRM requires an improved system for managing and updating clinical trial information across its network of Alpha Clinic - Community Care Centers of Excellence (AC-CCCE) as well as the CIRM-funded clinical trials. The AC-CCCE network clinical trial information is to be displayed on a dashboard alongside other CIRM-funded clinical trials, such that patients, researchers and the general public can browse real-time information about relevant clinical trials on one platform.

2. Objectives To achieve this aim, CIRM is seeking to develop a platform that performs the following:

1. Provides a patient-facing clinical trial dashboard to enhance patient navigation of CIRM-funded clinical trials and trials in the AC-CCCE network;

2. Enable sites within the AC-CCCE network to customize information for their trial site and remain up-to-date with changes to ClinicalTrials.gov trial record;

3. Maintains a robust database of clinical trials combining information from ClinicalTrials.gov, CIRM, and the AC-CCCE network;

4. Provides a back-end portal for users to communicate and file share to support clinical trial recruitment and enrollment.

3. Scope of Work The contractor will be responsible for developing the following:

3.1 Patient-Facing Clinical Trials Dashboard: Build a dashboard that integrates data from multiple sources: ClinicalTrials.gov, CIRM grants management system (GMS; an in-house database), and manually entered data. The dashboard will use ClinicalTrials.gov’s new API to enable data extraction from ClinicalTrials.gov, ensuring seamless synchronization of trial statuses and updates. Information about CIRM-funded clinical trials will be incorporated from CIRM GMS. Alpha Clinic site data will be contributed manually and will integrate with data extracted from ClinicalTrials.gov. The Alpha Clinic site should also have the ability to edit fields extracted from ClinicalTrials.gov. For each clinical trial, information will be displayed from ClinicalTrials.gov and either AC network or CIRM GMS. Clinical Trial information to be included and the data sources are listed in the table below.

In addition to information displayed directly on the dashboard, each clinical trial entry will link to ClinicalTrials.gov trial page and/or links to additional information such as trial summary, inclusion/exclusion criteria, or other information that may impact a patient’s participation in the trial.

The dashboard should include tools for enabling users to search, sort or otherwise organize content in an intuitive manner. For example, a free text search tool and facet filtering to query the clinical trials by one or more of the fields above. Required user interface features are listed in the table below.

Selected trial information such as name, sponsor and NCT number Site information such as contact, phone and email, and a map

3.2. Back-end Portal: Build a portal for administering the clinical trials dashboard and communicating across members. Key functions are outlined in the table below.

CIRM staff credentials for global administrator access (unrestricted access) Controlled access for CIRM awardees and AC site contacts restricted by group membership to edit clinical trial information imported from all three sources: ClinicalTrials.gov, CIRM GMS, and manual contributions A patient can navigate the dashboard and find active trials based on their disease indication and location.

A CIRM team member can view and edit clinical trials information, as well as assign users to groups. A trial site coordinator belongs to a group for a clinical trial and can edit that clinical trial’s information but not other clinical trials.

Trial site-specific content for management of multiple trial sites per clinical trial Clinical Trial X has multiple trial sites in the AC network, portal users in Clinical Trial X Group can coordinate information across sites such as clinical protocol, patient education materials or other trial-specific information.

Group administrators can also curate the formatting of the summary of inclusion/exclusion criteria.

A push notification system to alert a Group of users about updates to the clinicaltrials.gov record Users in Group X manage different sites for the same trial and share files and messages related to patient enrollment.

Changes to ClinicalTrials.gov clinical trial record prompts site-specific contact(s) to review record change.

User data security Measures to ensure data fidelity Compliance with CIRM’s policies Encrypted messaging and file storage.

A platform for ingesting, harmonizing, and interoperating on clinical data and preclinical research data.

Back-end Portal User interface The user interface of the back-end portal will facilitate the administration of the public-facing dashboard and the use of the file-sharing and communication functions. Required user interface features of the back-end portal are listed in the table below.

4. Deliverables

· A fully functional Patient-Facing Clinical Trials Dashboard deployed on CIRM’s infrastructure.

· A robust clinical trials database and back-end portal for system users.

· Training materials for system users.

· Maintenance of the portal for the next 18 months after deployment, including client support requests and queries

5. Project Timeline The project will commence on [Start Date] and is expected to be completed by [End Date, 12-17 weeks plus review time by CIRM]. Key milestones include:

· Project Kickoff: [Date TBD]

· Collaborate with CIRM to design the dashboard and portal, ensuring it meets the needs of various stakeholders: [Date TBD]

· Develop functional prototype of the dashboard and portal, including API integration: [Date TBD]

· Review and refine the prototype with CIRM to finalize the design and features: [Date TBD]

· Implement a production-grade dashboard and portal based on the reviewed prototype on CIRM’s infrastructure: [Date TBD]

· First round of user testing: [Date TBD]

· System go-live: [Date TBD]

· Post-implementation review: [Date TBD]

· Ongoing maintenance and updates of the dashboard and portal performed by the contractor: [12 months]

6. Acceptance Criteria The system will be considered accepted by CIRM if it meets all specified functionalities and passes all acceptance tests as outlined in the detailed project specification document.

7. Confidentiality and Security Compliance All project activities must adhere to the confidentiality and security policies specified by CIRM, ensuring all patient and clinical data is handled securely.

8. Budget: $20,000 to $100,000