Project Initiation Checklist

□ Review and understand protocol completely
□ Develop project charter and scope document
□ Create comprehensive project plan
□ Establish project timeline and milestones
□ Define team roles and responsibilities
□ Set up project communication plan
□ Identify and document project risks
□ Establish budget and resource allocation

Site Selection & Activation

□ Identify potential research sites
□ Conduct site feasibility assessments
□ Review site capabilities and resources
□ Evaluate investigator qualifications
□ Conduct site selection visits
□ Complete site contracts and budgets
□ Coordinate site initiation visits
□ Ensure regulatory document collection

Regulatory Management

□ Prepare regulatory submission packages
□ Track IRB/EC submissions and approvals
□ Maintain regulatory binders (TMF)
□ Ensure protocol compliance
□ Manage protocol amendments
□ Coordinate safety reporting
□ Maintain investigator site files
□ Prepare for regulatory inspections

Budget & Financial Management

□ Develop detailed project budget
□ Track study costs and expenses
□ Process site payments
□ Monitor budget variance
□ Manage vendor contracts
□ Review and approve invoices
□ Conduct financial reconciliation
□ Prepare financial reports

Team Management

□ Recruit and onboard team members
□ Conduct team training sessions
□ Define clear roles and expectations
□ Hold regular team meetings
□ Monitor team performance
□ Address conflicts and issues
□ Provide feedback and coaching
□ Manage resource allocation

Vendor Management

□ Identify required vendors (CRO, labs, etc.)
□ Develop vendor selection criteria
□ Conduct vendor assessments
□ Negotiate contracts and budgets
□ Monitor vendor performance
□ Manage vendor relationships
□ Review vendor deliverables
□ Conduct vendor audits

Patient Recruitment & Retention

□ Develop recruitment strategy
□ Create recruitment materials
□ Monitor enrollment progress
□ Implement retention strategies
□ Track screen failures
□ Address recruitment challenges
□ Coordinate with sites on recruitment
□ Report recruitment metrics

Data Management

□ Develop data management plan
□ Design case report forms (CRFs)
□ Set up EDC system
□ Create data validation checks
□ Monitor data quality
□ Manage database lock process
□ Coordinate data cleaning
□ Prepare for database audit

Monitoring & Quality Assurance

□ Develop monitoring plan
□ Schedule monitoring visits
□ Review monitoring reports
□ Track and close action items
□ Manage protocol deviations
□ Oversee CAPA implementation
□ Coordinate quality audits
□ Prepare for inspections

Safety Management

□ Establish safety monitoring plan
□ Set up SAE reporting process
□ Coordinate DSMB meetings
□ Review safety signals
□ Manage safety database
□ Ensure timely safety reporting
□ Communicate safety updates
□ Maintain safety documentation

Communication Management

□ Develop communication matrix
□ Schedule regular status meetings
□ Prepare progress reports
□ Manage stakeholder expectations
□ Coordinate team communications
□ Distribute important updates
□ Maintain communication logs
□ Facilitate issue resolution

Risk Management

□ Conduct risk assessments
□ Develop risk mitigation plans
□ Monitor risk indicators
□ Update risk register regularly
□ Implement contingency plans
□ Report critical risks
□ Review lessons learned
□ Adjust strategies as needed

Study Closure

□ Develop closure plan
□ Coordinate final monitoring visits
□ Ensure data completeness
□ Manage database lock
□ Archive study documents
□ Close out vendor contracts
□ Complete financial reconciliation
□ Prepare final study report