> ## Documentation Index
> Fetch the complete documentation index at: https://docs.carelane.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Monitoring

> Site and data monitoring practices

Monitoring ensures data quality and protocol compliance. Carelane supports both centralized and on-site monitoring approaches.

## Monitoring Approaches

### Centralized Monitoring

Remote review of data and metrics:

| Activity             | Description                     |
| -------------------- | ------------------------------- |
| **Data Review**      | Review entered data for quality |
| **Metric Tracking**  | Monitor performance indicators  |
| **Query Management** | Raise and track queries         |
| **Trend Analysis**   | Identify patterns across sites  |

### On-Site Monitoring

In-person site visits:

| Activity                 | Description               |
| ------------------------ | ------------------------- |
| **Source Verification**  | Compare CRF to source     |
| **Regulatory Review**    | Check essential documents |
| **Training**             | Address issues in person  |
| **Process Verification** | Observe site procedures   |

### Risk-Based Monitoring

Focus monitoring resources on risk:

| Risk Level | Monitoring Intensity      |
| ---------- | ------------------------- |
| **High**   | Frequent, detailed review |
| **Medium** | Regular review            |
| **Low**    | Periodic sampling         |

## Centralized Monitoring in Carelane

### Data Review

<Steps>
  <Step title="Access Submitted Data">
    Navigate to participant records with submitted data.
  </Step>

  <Step title="Review Entries">
    Examine data for completeness and accuracy.
  </Step>

  <Step title="Identify Issues">
    Note discrepancies or questions.
  </Step>

  <Step title="Raise Queries">
    Create queries for clarification.
  </Step>

  <Step title="Track Resolution">
    Monitor query responses.
  </Step>
</Steps>

### Key Metrics to Monitor

| Metric                    | What It Indicates            |
| ------------------------- | ---------------------------- |
| **Enrollment Rate**       | Site recruitment performance |
| **Data Entry Timeliness** | Operational efficiency       |
| **Query Rate**            | Data quality                 |
| **Protocol Deviations**   | Compliance                   |
| **Missing Data**          | Completeness                 |

### 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:

| CRF Data         | Source Document      |
| ---------------- | -------------------- |
| Demographics     | Medical record       |
| Vital signs      | Visit notes          |
| Lab results      | Lab reports          |
| Concomitant meds | Prescription records |
| Adverse events   | Clinical notes       |

### SDV Rate

Determine appropriate SDV rate:

| Risk               | SDV Rate        |
| ------------------ | --------------- |
| **Critical Data**  | 100%            |
| **Safety Data**    | High percentage |
| **Efficacy Data**  | Risk-based      |
| **Administrative** | Sample only     |

## 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:

| Metric              | Target              |
| ------------------- | ------------------- |
| **Open Queries**    | Minimize            |
| **Query Age**       | Resolve promptly    |
| **Query Rate**      | Below threshold     |
| **Resolution Time** | Within expectations |

## Site Performance Monitoring

### Performance Indicators

Track by site:

| Indicator        | Purpose               |
| ---------------- | --------------------- |
| **Enrollment**   | Recruitment progress  |
| **Retention**    | Participant dropout   |
| **Data Quality** | Query and error rates |
| **Timeliness**   | Data entry promptness |
| **Compliance**   | Protocol adherence    |

### Performance Review

Conduct periodic reviews:

<Steps>
  <Step title="Compile Metrics">
    Gather site performance data.
  </Step>

  <Step title="Compare Sites">
    Benchmark against other sites.
  </Step>

  <Step title="Identify Outliers">
    Note high and low performers.
  </Step>

  <Step title="Investigate">
    Understand reasons for variation.
  </Step>

  <Step title="Take Action">
    Support struggling sites; learn from top performers.
  </Step>
</Steps>

## Monitoring Documentation

### What to Document

| Item               | Documentation          |
| ------------------ | ---------------------- |
| **Reviews**        | Date, scope, findings  |
| **Queries**        | Tracked in system      |
| **Actions**        | Issues and resolutions |
| **Communications** | Site interactions      |

### Monitoring Reports

Generate monitoring reports:

* Site visit reports
* Centralized monitoring summaries
* Quality metrics summaries

## Monitor Roles in Carelane

| Role                    | Monitoring Access                  |
| ----------------------- | ---------------------------------- |
| **Data Reviewer**       | Full data access, query capability |
| **Reviewer**            | Read-only data access              |
| **Study Administrator** | Full access                        |

## Best Practices

<AccordionGroup>
  <Accordion title="Risk-Based Focus">
    Concentrate monitoring on high-risk areas and data.
  </Accordion>

  <Accordion title="Proactive Approach">
    Don't wait for problems; monitor continuously.
  </Accordion>

  <Accordion title="Clear Queries">
    Write clear, actionable queries.
  </Accordion>

  <Accordion title="Timely Follow-up">
    Address issues promptly.
  </Accordion>

  <Accordion title="Document Everything">
    Keep complete monitoring records.
  </Accordion>
</AccordionGroup>

## Related

<CardGroup cols={2}>
  <Card title="Data Quality" icon="magnifying-glass" href="/data-quality">
    Query management details.
  </Card>

  <Card title="Reports" icon="chart-bar" href="/exports-reports/reports">
    Monitoring reports.
  </Card>
</CardGroup>