> ## 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.

# Protocol Compliance

> Ensure study conduct follows the protocol

Protocol compliance means conducting the study according to the approved protocol. Carelane provides tools to support and monitor compliance.

## Protocol Elements in Carelane

### Mapping Protocol to Configuration

| Protocol Section       | Carelane Configuration   |
| ---------------------- | ------------------------ |
| Objectives             | Study objectives         |
| Study Design           | Arms, design type        |
| Eligibility            | Screening questionnaires |
| Schedule of Activities | Participant pathways     |
| Assessments            | Questionnaires           |
| Data Collection        | CRF design               |

## Implementing Protocol Requirements

### Eligibility Criteria

Implement eligibility screening:

<Steps>
  <Step title="Create Screening Forms">
    Design questionnaires capturing inclusion/exclusion criteria.
  </Step>

  <Step title="Add to Pathway">
    Include in screening visit.
  </Step>

  <Step title="Review Process">
    Establish eligibility review procedures.
  </Step>

  <Step title="Document Decisions">
    Record eligibility determinations.
  </Step>
</Steps>

### Visit Schedule

Match pathway to protocol SoA:

| Protocol            | Carelane                   |
| ------------------- | -------------------------- |
| Visit 1 - Screening | Screening Visit in pathway |
| Visit 2 - Baseline  | Baseline Visit             |
| Visit 3 - Week 4    | Week 4 Visit               |
| Visit N - EOS       | End of Study Visit         |

### Required Assessments

Ensure all protocol assessments are captured:

* Map each assessment to a questionnaire
* Include all required data points
* Match visit windows to protocol

## Deviation Management

### What is a Protocol Deviation?

Any departure from the approved protocol:

| Type            | Examples                          |
| --------------- | --------------------------------- |
| **Eligibility** | Enrolled ineligible participant   |
| **Visit**       | Missed visit, visit out of window |
| **Assessment**  | Missed required assessment        |
| **Procedure**   | Incorrect procedure performed     |

### Documenting Deviations

<Steps>
  <Step title="Identify Deviation">
    Recognize when deviation has occurred.
  </Step>

  <Step title="Document">
    Record what happened and why.
  </Step>

  <Step title="Assess Impact">
    Evaluate impact on participant safety and data.
  </Step>

  <Step title="Implement Corrections">
    Take corrective actions as needed.
  </Step>

  <Step title="Report">
    Report per protocol and regulatory requirements.
  </Step>
</Steps>

### Deviation Categories

| Severity  | Criteria                                              |
| --------- | ----------------------------------------------------- |
| **Major** | Affects participant safety, data integrity, or rights |
| **Minor** | Administrative or procedural; no safety/data impact   |

## Compliance Monitoring

### Site-Level Compliance

Monitor compliance indicators:

| Indicator                 | What to Look For                |
| ------------------------- | ------------------------------- |
| **Visit Completion**      | Visits conducted within windows |
| **Assessment Completion** | Required assessments performed  |
| **Query Rate**            | Data quality indicators         |
| **Deviation Reports**     | Frequency and severity          |

### Study-Level Compliance

Track overall study compliance:

* Protocol deviation trends
* Site comparison
* Systemic issues identification

## Protocol Amendments

When the protocol changes:

<Steps>
  <Step title="Receive Amendment">
    Obtain approved protocol amendment.
  </Step>

  <Step title="Assess Impact">
    Determine impact on Carelane configuration.
  </Step>

  <Step title="Update Configuration">
    Modify questionnaires, pathways, or settings.
  </Step>

  <Step title="Communicate">
    Notify sites of changes.
  </Step>

  <Step title="Train">
    Provide training on new requirements.
  </Step>

  <Step title="Document">
    Record amendment implementation.
  </Step>
</Steps>

<Warning>
  Some configuration changes may affect existing data or require migration. Plan amendments carefully.
</Warning>

## Tools for Compliance

### Pathway Windows

Configure visit windows to flag out-of-window visits:

* Target visit dates
* Acceptable ranges
* Overdue alerts

### Required Fields

Make critical assessments required:

* Cannot complete without entering
* Reduces missing data

### Validation Rules

Add validation to catch errors:

* Range checks
* Logical checks
* Cross-field validation

## Best Practices

<AccordionGroup>
  <Accordion title="Match Protocol Exactly">
    Configure Carelane to match the protocol exactly, including terminology.
  </Accordion>

  <Accordion title="Train on Protocol">
    Ensure all site staff understand protocol requirements.
  </Accordion>

  <Accordion title="Monitor Proactively">
    Don't wait for issues; monitor compliance continuously.
  </Accordion>

  <Accordion title="Document Promptly">
    Document deviations as soon as they're identified.
  </Accordion>
</AccordionGroup>

## Related

<CardGroup cols={2}>
  <Card title="Monitoring" icon="magnifying-glass-chart" href="/methodology/monitoring">
    Site and data monitoring.
  </Card>

  <Card title="Participant Pathways" icon="route" href="/participants/participant-pathways">
    Configure study schedules.
  </Card>
</CardGroup>