Smartsheet Free Clinical Research Project Manager Checklists

Smartsheet template for clinical trial project managers to track tasks across multiple studies. This free digital checklist organizes site activation, enrollment tracking, budget monitoring, vendor management, and regulatory submissions in a collaborative platform accessible to your entire research team.

Study Startup Phase Checklist

□ Protocol finalization and review
□ Budget development and approval
□ Site identification and selection
□ Regulatory document preparation
□ Contract and budget negotiations
□ Ethics committee submissions
□ Study team identification
□ Kick-off meeting planning
□ Timeline: ____________
□ Status: ____________
□ Owner: ____________
□ % Complete: ____________

Enrollment Tracking Dashboard

□ First participant enrolled date
□ Weekly enrollment targets set
□ Actual vs planned enrollment
□ Screen failure tracking
□ Site-specific enrollment rates
□ Recruitment material distribution
□ Enrollment projections updated
□ Rescue plan activated if needed
□ Target: ____________
□ Actual: ____________
□ Variance: ____________
□ Action Items: ____________

Milestone Management Grid

□ Protocol approval
□ First site activated
□ First participant in (FPI)
□ 25% enrollment
□ 50% enrollment
□ 75% enrollment
□ Last participant in (LPI)
□ Last participant last visit (LPLV)
□ Planned Date: ____________
□ Actual Date: ____________
□ Days Variance: ____________
□ Impact Assessment: ____________

Budget Tracking Worksheet

□ Initial budget approved
□ Site payments processed
□ Vendor invoices tracked
□ Monthly burn rate calculated
□ Variance reports generated
□ Forecast updates completed
□ Change orders documented
□ Financial reconciliation done
□ Budget: $____________
□ Spent: $____________
□ Remaining: $____________
□ % Used: ____________

Risk Register Template

□ Risk identification completed
□ Risk assessment conducted
□ Risk owner assigned
□ Mitigation plan developed
□ Risk monitoring schedule set
□ Trigger points defined
□ Contingency plan ready
□ Risk review meetings held
□ Risk Level: ____________
□ Probability: ____________
□ Impact: ____________
□ Response: ____________

Vendor Performance Tracker

□ Vendor contracts executed
□ Deliverables timeline set
□ KPIs established
□ Performance reviews scheduled
□ Invoice approval process
□ Issue escalation path defined
□ Quality metrics tracked
□ Relationship meetings held
□ Vendor: ____________
□ Score: ____________
□ Issues: ____________
□ Action: ____________

Regulatory Compliance Matrix

□ Protocol version control
□ Amendment tracking
□ Consent form versions
□ Site regulatory files
□ Safety report distribution
□ TMF completeness
□ Inspection readiness
□ CAPA tracking
□ Item: ____________
□ Status: ____________
□ Due: ____________
□ Complete: ____________

Meeting Management Tool

□ Meeting purpose defined
□ Agenda distributed
□ Attendees confirmed
□ Materials prepared
□ Minutes template ready
□ Action items tracked
□ Follow-up scheduled
□ Decisions documented
□ Meeting: ____________
□ Date: ____________
□ Attendees: ____________
□ Actions: ____________

Data Management Checklist

□ CRF design completed
□ EDC system built
□ User acceptance testing
□ Training completed
□ Data entry timelines set
□ Query management process
□ Data cleaning milestones
□ Database lock criteria
□ Metric: ____________
□ Target: ____________
□ Current: ____________
□ Gap: ____________

Communication Plan Matrix

□ Stakeholder identified
□ Communication frequency set
□ Channel determined
□ Message templates created
□ Distribution list maintained
□ Feedback mechanism established
□ Escalation path defined
□ Archive system in place
□ Stakeholder: ____________
□ Frequency: ____________
□ Method: ____________
□ Owner: ____________

Quality Metrics Dashboard

□ Protocol deviations tracked
□ Monitoring findings logged
□ CAPA implementation
□ Training compliance
□ Document quality scores
□ Audit findings tracked
□ Process improvements identified
□ Lessons learned captured
□ Metric: ____________
□ Goal: ____________
□ Actual: ____________
□ Trend: ____________

How the Smartsheet Free Clinical Research Project Manager Checklists works

Download the free Smartsheet template and customize for your trial phases. Assign tasks to team members, set automated reminders for regulatory deadlines, track budget burn rates, and monitor site performance metrics. Share with sponsors and CROs for real-time collaboration and reporting.

Paper checklists don’t work when managing 5-15 simultaneous trials across multiple sites. Smartsheet provides centralized tracking, automated notifications for critical deadlines, and audit trails that satisfy regulatory requirements. Teams using digital project management reduce delays by 40%.

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