Human Research Protection Program Software

The Vendor is required to provide human research protection program (HRPP) software solution to modernize and streamline the management, oversight, and compliance of human subject research.
- The platform must support the full lifecycle of research protocols, including submission, review, and approval, monitoring, and reporting.
- Requirement:
1. Core system capabilities
• Support end-to-end protocol lifecycle management, including submission, review, modification, renewal, and closure
• Configurable workflows with automated routing, notifications, and approvals
• Enable electronic document management with version control and auditability
• Support multi-user collaboration and real-time updates
2. Compliance and audit
• Maintain a comprehensive, tamper-evident audit trail for all system and user actions, including changes to data, workflows, and permissions
• Capture detailed audit metadata that is searchable and viewable at multiple levels (user id, timestamp, prior and new values, and context)
• Ensure compliance with 45 CFR 46 and other applicable regulatory frameworks
• Recording of actions performed by each user level including proxy and delegated levels. Administrative impersonation for troubleshooting must be supported.
3. Workflow and form management
• Unlimited protocol state changes, notifications and triggers
• Unlimited sequential and parallel steps
• Authorized users can manually edit workflow states and update workflows as regulations change without vendor involvement
• Configurable form sets with logic-based questions, validation rules, and versioning
• Allow authorized users to create and modify forms and workflows without vendor intervention
• Support dynamic data entry fields and integration with internal/external data sources
• Forms support validation rules that trigger error notifications.
• Forms support inclusion of attachments of most common file formats.
4. Board and committee administration
• Enable management of board committees, member roles, and expertise profiles with linked documents such as CV’s or evaluations
• Tools for meeting scheduling, agenda creation, attendance tracking, and minute documentation
• Facilitate collaborative review, comment tracking, and decision documentation
5. Protocol review and monitoring
• Support initial review, continuing review, modifications, and renewals with full version control
• Provide configurable workflows for monitoring activities and follow-up actions
• Automated process for evaluating training reports from existing systems for required training, accommodating differing criteria based on information in the protocol.
• This will include visual indicators and notification to investigators when personnel training is deficient.
• Enable quality assurance and post-approval monitoring (QA/PAM), including adverse event tracking, noncompliance reporting, and CAPA management
6. Communication and notifications
• Provide automated notifications and messaging based on user actions and workflow triggers
• Maintain a complete record of communications within the system
• Enable configurable email templates and delivery tracking
7. Accessibility and usability
• Meet WCAG 2.1 level AA accessibility standards with at least 85% compliance
• Provide intuitive user interfaces and printer-friendly views
• Include full-text search across all system content
• User roles with access controls that are configurable without vendor involvement.