Monitoring Approaches
Centralized Monitoring
Remote review of data and metrics:On-Site Monitoring
In-person site visits:Risk-Based Monitoring
Focus monitoring resources on risk:Centralized Monitoring in Carelane
Data Review
1
Access Submitted Data
Navigate to participant records with submitted data.
2
Review Entries
Examine data for completeness and accuracy.
3
Identify Issues
Note discrepancies or questions.
4
Raise Queries
Create queries for clarification.
5
Track Resolution
Monitor query responses.
Key Metrics to Monitor
Using Reports
Leverage built-in reports:- Enrollment reports
- Query status reports
- Visit completion reports
- Site comparison reports
Source Data Verification
What to Verify
Compare CRF data to source documents:SDV Rate
Determine appropriate SDV rate:Query Management
Effective Queries
Write queries that:- Clearly state the issue
- Specify what information is needed
- Reference specific data points
- Set appropriate expectations
Query Tracking
Monitor query status:Site Performance Monitoring
Performance Indicators
Track by site:Performance Review
Conduct periodic reviews:1
Compile Metrics
Gather site performance data.
2
Compare Sites
Benchmark against other sites.
3
Identify Outliers
Note high and low performers.
4
Investigate
Understand reasons for variation.
5
Take Action
Support struggling sites; learn from top performers.
Monitoring Documentation
What to Document
Monitoring Reports
Generate monitoring reports:- Site visit reports
- Centralized monitoring summaries
- Quality metrics summaries
Monitor Roles in Carelane
Best Practices
Risk-Based Focus
Risk-Based Focus
Concentrate monitoring on high-risk areas and data.
Proactive Approach
Proactive Approach
Don’t wait for problems; monitor continuously.
Clear Queries
Clear Queries
Write clear, actionable queries.
Timely Follow-up
Timely Follow-up
Address issues promptly.
Document Everything
Document Everything
Keep complete monitoring records.
Related
Data Quality
Query management details.
Reports
Monitoring reports.