Go-Live & Operations
Go-Live & Operations
Category: Customer Lifecycle | Audience: undefined | Page: 29 of 33
Table of Contents
- Review Incident Severity Definitions
Go-Live & Operations
Welcome to the Go-Live & Operations documentation for the Elixia Health clinical trial platform. This guide will help you understand the essential operational information needed for a successful go-live and ongoing use of our platform.
Key Concepts
Before diving into the details, let's cover some key concepts that will help you navigate the platform effectively:
- Uptime SLA: Our target uptime during maintenance is 99.9%, ensuring minimal disruption to your operations.
- Outage Communication: We have a clear process for communicating outages to the right people, ensuring timely resolution.
- Monitoring: Comprehensive monitoring is in place to ensure GDPR compliance, technical security, and system health.
- Incident Triage: Incidents are quickly and effectively assessed to ensure the right resources are allocated for timely resolution.
- Audit Logs: You can access audit logs to track and monitor platform activity, ensuring compliance and data integrity.
What You Can Do
Here are the main capabilities you can leverage for go-live and ongoing operations:
- Monitor system uptime and receive notifications for outages
- Access comprehensive audit logs for tracking platform activity
- Understand incident severity definitions and triage processes
- Ensure GDPR compliance through automated monitoring and alerts
How To
Access Audit Logs
Access Audit Logs
To access audit logs, follow these steps:
- Log in to the MCT platform.
- Navigate to the MCT login page and enter your credentials
- Ensure you have appropriate permissions to access audit logs (Admin or Compliance Officer role required)
- Multi-factor authentication may be required for security access
- Click on the "Audit" tab.
- In the main navigation menu, locate and click on the "Administration" or "Settings" section
- Select the "Audit" tab to access the audit log viewer
- You will see the audit log dashboard with available options
- Select the type of audit log you want to view:
- PortalUserAuditLog: Tracks user login/logout events, password changes, and user account modifications
- DataChangeLog: Records all modifications to patient data, study data, and configuration changes
- PermissionAuditLog: Logs all user permission assignments, role changes, and access modifications
- FileAccessLog: Tracks who accessed, downloaded, or uploaded files and documents
- SystemEventLog: Captures system-level events, API calls, and integration activities
- ComplianceLog: Documents compliance-related activities and certifications
- SecurityLog: Records security events, authentication attempts, and security-related incidents
- Select the log type most relevant to your compliance or investigation needs
- Choose the date range and other filters as needed:
- Date Range: Select the start and end dates for the audit period you want to review
- Use the calendar picker or enter dates manually (format: MM/DD/YYYY)
- Typically, review periods range from 1 day to 90 days
- User Filter: Narrow results by selecting a specific user or user role
- Study/Sponsor Filter: Filter logs by specific study or sponsor (if applicable)
- Action Type Filter: Select specific actions to view (e.g., "Create", "Update", "Delete", "Export")
- Resource Filter: Filter by the specific resource affected (e.g., patient records, documents, settings)
- Status Filter: Filter by action status (e.g., "Success", "Failed", "Pending")
- Click "Search" to view the audit logs.
- The system will retrieve and display matching audit log entries
- Results are typically displayed in a table format with the following columns:
- Timestamp: Date and time of the event
- User: The user who performed the action
- Action: The action performed (Create, Read, Update, Delete, Export, etc.)
- Resource: The data or system component affected
- Details: Additional information about the change or action
- Status: Whether the action succeeded or failed
- IP Address: The IP address from which the action was performed (for security tracking)
- Review and Export Audit Log Results:
- Click on individual log entries to view detailed information about specific actions
- Use the "Export" button to download audit logs in CSV, PDF, or Excel format
- Save exported logs for compliance documentation and archival purposes
- Share relevant logs with auditors or compliance teams as needed
- Best Practices for Audit Log Review:
- Review audit logs regularly (daily, weekly, or monthly depending on activity volume)
- Look for unusual patterns such as bulk deletions, after-hours access, or repeated failed login attempts
- Document any concerning findings and escalate to security or compliance teams
- Retain audit logs for the required retention period (typically 7 years for HIPAA compliance)
- Use automated alerts for critical events (e.g., large data exports, permission changes, system errors)
Review Incident Severity Definitions
To review incident severity definitions, follow these steps:
- Refer to the documentation on severity definitions.
- Access the Incident Management documentation in your compliance or operational resources
- Review the Incident Response Plan (IRP) specific to your organization
- Understand your organization's incident classification and escalation procedures
- Understand the factors considered for defining severity levels:
- Percentage of Clients Affected: How many customers or studies are impacted by the incident
- 1-5% of clients = Lower severity impact
- 5-25% of clients = Medium severity impact
- 25-50% of clients = High severity impact
- 50%+ of clients = Critical severity impact
- Feature Categories: The type of functionality affected
- Core trial management features (e.g., patient enrollment, data entry) = Higher priority
- Supporting features (e.g., reporting, notifications) = Lower priority
- Security or compliance features = Critical priority
- Data Impact: Whether PHI, PII, or other sensitive data is affected or at risk
- System Impact: The extent to which platform availability is affected
- Business Impact: Effect on trial operations, regulatory compliance, or patient safety
- Duration: How long the incident has been occurring or is expected to last
- Familiarize yourself with the severity levels and their descriptions:
- SEV 1 (Critical/P1 - Immediate Response Required)
- Definition: Complete system outage or critical functionality is completely unavailable
- Characteristics:
- Platform is down or inaccessible for all users
- Core features (patient enrollment, data entry, trial operations) are unavailable
- Security breach or data integrity compromise detected
- Patient safety is directly at risk
- Regulatory non-compliance is imminent
- Response Time: Immediate (within 15 minutes)
- Escalation: Escalate to C-level executives and regulatory bodies if applicable
- Examples: Complete database failure, ransomware attack, GDPR breach affecting 50%+ of data subjects
- Communication: Notify all affected customers immediately, update every 30 minutes
- SEV 2 (High/P2 - Urgent Response Required)
- Definition: Major functionality is degraded or significantly impaired for a large percentage of users
- Characteristics:
- Key features are unavailable or performing very slowly (>5 minutes response time)
- 25-50% of users or multiple customers are affected
- Data accuracy issues affecting trial operations
- Workaround exists but is cumbersome and time-consuming
- Potential for data loss or security compromise
- Response Time: Within 1 hour
- Escalation: Escalate to department heads and project sponsors
- Examples: Patient enrollment module down, data sync failures, authentication issues affecting multiple sites
- Communication: Notify affected customers within 1 hour, provide updates every 2 hours
- SEV 3 (Medium/P3 - Standard Response)
- Definition: Moderate functionality is affected or performance is noticeably degraded
- Characteristics:
- Non-critical features are unavailable or performing poorly (2-5 minute response times)
- 5-25% of users are affected or impact is limited to one or two customers
- Workaround is readily available
- No direct impact on patient safety or trial data integrity
- Partial functionality is available for users to continue operations
- Response Time: Within 4-8 hours
- Escalation: Escalate to supervisor or team lead
- Examples: Reporting module is slow, email notifications delayed, minor UI issues
- Communication: Update affected customers within 4 hours, then as needed
- SEV 4 (Low/P4 - Standard Support)
- Definition: Minor functionality is affected or there are minor performance issues
- Characteristics:
- Cosmetic issues or minor feature problems (e.g., display formatting, non-essential buttons)
- Performance impact is minimal (<2 second delay)
- Only one or two users affected
- Full workaround exists
- No impact on trial operations or data integrity
- Response Time: Within 1-2 business days
- Escalation: Standard support ticket escalation process
- Examples: Typo in UI, minor formatting issue, single user unable to access non-critical feature
- Communication: Acknowledge ticket, provide updates during standard business hours
- SEV 5 (Minimal/P5 - Documentation/Enhancement)
- Definition: Feature request, documentation issue, or question with no impact on operations
- Characteristics:
- Questions or documentation requests
- Feature suggestions or enhancement requests
- Informational issues with no operational impact
- No workaround needed (operations not affected)
- Response Time: Within 1 week during business hours
- Escalation: No escalation required
- Examples: Documentation typo, feature request, general question about functionality
- Communication: Respond to tickets during business hours (9 AM - 5 PM)
- Additional Incident Severity Considerations:
- Security Incidents: Any security-related incident (breach, attempted breach, unauthorized access) is minimum SEV 2
- Data Integrity Issues: Any data loss or corruption is minimum SEV 2
- Regulatory Compliance: Any incident affecting HIPAA, GDPR, or 21 CFR Part 11 compliance is minimum SEV 1
- Patient Safety: Any incident that could affect patient safety is automatically SEV 1
- Multi-Site Impact: Incidents affecting multiple research sites are escalated one severity level
- Out-of-Hours Impact: Incidents occurring outside business hours may be escalated one level
- Best Practices for Incident Management:
- Train your team on severity definitions and response procedures
- Document all incidents in an incident tracking system
- Conduct post-incident reviews for SEV 1 and SEV 2 incidents
- Maintain incident communication logs for compliance purposes
- Escalate appropriately based on severity to ensure timely resolution
- Keep customers informed with regular status updates for SEV 1 and SEV 2 incidents
Tips & Best Practices
- Monitor Uptime: Keep an eye on system uptime to ensure minimal disruption to your operations.
- Review Audit Logs: Regularly review audit logs to ensure compliance and identify any potential issues.
- Understand Incident Severity: Familiarize yourself with incident severity definitions to ensure efficient incident response.
- Stay Informed: Set up alerts or notifications for specific audit log events to stay informed about platform activity.
Next Steps
- Review Documentation: Go through the provided documentation to understand the platform's operational capabilities and processes.
- Familiarize with Tools: Get comfortable with the tools and processes available for monitoring, incident triage, and audit log access.
- Practice Scenarios: Practice incident triage scenarios to ensure effective implementation of the process.
- Contact Support: If you have any questions or need assistance, reach out to your platform administrator or contact our support team.
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Generated from MCT Knowledge Base • v1.1.0 • January 2, 2026