1. Monitor and Control
1.1. Data management
1.1.1. Retain participant records according to regulatory requirements
1.1.2. Ensure all study documents are securely archived
1.1.3. Collect and archive all study documents
1.1.4. Document the data locking process
1.1.5. Ensure all study documents are properly stored
1.2. Supply management
1.2.1. Interim quality checking for material supply
1.3. Quality management
1.3.1. Address data discrepancies/protocol deviations
1.3.2. Monitor recruitment process
1.4. Site management
1.4.1. Conduct final monitoring visits to ensure site compliance
1.4.2. Initial and interim site visit to ensure site readiness and protocol adherence during the trial
2. Closing
2.1. Retention/Archiving
2.1.1. Prepare for potential audits or inspections
2.2. Study Closure
2.2.1. Close out the site following study completion
2.3. Statistical Analysis
2.3.1. General final report
2.3.2. Perform statistical analysis of locked data
2.4. Data Locking
2.4.1. Lock the database
2.4.2. Finalize all data entries
3. Initiation Phase
3.1. Protocol development
3.2. Preliminary budgeting
3.3. Feasibility assessment
3.4. Stakeholders identification and engagement
3.5. Site selection St Joseph's
3.5.1. Site identification
3.5.2. Site feasibility assessment
3.5.3. Finalize contracts and agreements with selected sites
3.6. Regulatory approvals
3.6.1. Prepare and submit protocol to Heath Canada
3.6.2. Obtain Ethics Committee approvals
3.6.3. Respond to inquiries and obtain final approvals
3.7. Study Start-up
3.7.1. Train Site Personnel
3.7.2. Set up study infrastructure
3.7.3. Ship investigational product and study materials
4. Planning Phase
4.1. Site recruitment target set
4.2. Define project timeline
4.3. Define Work Breakdown Structure
4.4. Communication Plan
4.5. Budget and resource allocation
4.6. Risk management plan
5. Implementation
5.1. Study Recruitment
5.1.1. Recruit patients
5.1.2. Conduct intial screening and baseline assessments
5.2. Data Collection
5.2.1. Collect data regularly
5.3. Data Cleaning
5.3.1. Review and clean collected data
5.3.2. Query resolution
5.3.3. Prepare data for analysis