> ## 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.

# Safety Reporting

> Document and report safety events

Safety reporting is critical for protecting participant welfare. Carelane provides tools to capture and track safety information throughout the study.

## Safety Concepts

### Adverse Events (AEs)

Any untoward medical occurrence in a participant:

| Category | Description                                       |
| -------- | ------------------------------------------------- |
| **AE**   | Any adverse event                                 |
| **SAE**  | Serious adverse event (per regulatory definition) |
| **AESI** | Adverse event of special interest                 |

### Reporting Requirements

Safety events may require reporting to:

* IRB/Ethics Committee
* Regulatory authorities
* Sponsor safety department
* Data Safety Monitoring Board

## Capturing Safety Data

### AE Questionnaires

Design questionnaires for AE capture:

| Field                    | Purpose                |
| ------------------------ | ---------------------- |
| **Event Description**    | What happened          |
| **Start Date**           | When it began          |
| **End Date**             | When it resolved       |
| **Severity**             | Mild, moderate, severe |
| **Seriousness Criteria** | SAE determination      |
| **Relatedness**          | Relationship to study  |
| **Outcome**              | Resolution status      |
| **Action Taken**         | Response to event      |

### SAE Identification

Include fields to identify SAEs:

| Criterion               | Triggers SAE |
| ----------------------- | ------------ |
| Death                   | Yes          |
| Life-threatening        | Yes          |
| Hospitalization         | Yes          |
| Disability              | Yes          |
| Congenital anomaly      | Yes          |
| Important medical event | Yes          |

## Safety Workflow

<Steps>
  <Step title="Event Occurs">
    Site becomes aware of adverse event.
  </Step>

  <Step title="Initial Documentation">
    Site enters AE into Carelane questionnaire.
  </Step>

  <Step title="Severity Assessment">
    Site assesses severity and seriousness.
  </Step>

  <Step title="SAE Determination">
    If SAE, initiate expedited reporting.
  </Step>

  <Step title="Follow-up">
    Continue documenting until resolution.
  </Step>

  <Step title="Study Team Review">
    Study team reviews safety data.
  </Step>
</Steps>

## AE Form Design

### Essential Fields

Include in your AE questionnaire:

```
Event Description (text)
Start Date (date)
End Date (date) - optional
Ongoing? (boolean)
Severity (choice: mild/moderate/severe)
Seriousness Criteria (multiple choice)
Relationship to Study (choice scale)
Action Taken (multiple choice)
Outcome (choice)
```

### Conditional Logic

Use conditions for follow-up:

* If SAE → Show additional SAE fields
* If ongoing → Hide end date
* If related → Show additional assessment fields

## Tracking and Follow-up

### AE Log

Maintain a log of all AEs:

| Information | Purpose                      |
| ----------- | ---------------------------- |
| All AEs     | Complete safety record       |
| Open AEs    | Events requiring follow-up   |
| SAEs        | Expedited reporting tracking |

### Follow-up Documentation

Document AE follow-up:

* Updates to event status
* Resolution information
* Outcomes
* Actions taken

## Reporting Timelines

### Regulatory Timelines

| Event Type                       | Typical Timeline |
| -------------------------------- | ---------------- |
| **Fatal/Life-threatening SAE**   | 7 days           |
| **Other SAE**                    | 15 days          |
| **Important Safety Information** | As required      |

<Warning>
  Reporting timelines vary by jurisdiction and sponsor requirements. Consult your protocol for specific requirements.
</Warning>

### Internal Reporting

Establish internal reporting procedures:

* Immediate notification for SAEs
* Periodic safety reviews
* Aggregate safety reporting

## Safety Review

### Ongoing Safety Review

Conduct regular safety reviews:

| Frequency     | Activity              |
| ------------- | --------------------- |
| **As occurs** | Individual SAE review |
| **Weekly**    | Review new AEs        |
| **Monthly**   | Safety summary review |
| **Periodic**  | DSMB/DMC reviews      |

### Safety Signals

Monitor for safety signals:

* Unexpected AE patterns
* Increased frequency
* New types of events
* Severity trends

## Data Quality for Safety

Ensure safety data quality:

| Aspect           | Approach            |
| ---------------- | ------------------- |
| **Completeness** | All fields required |
| **Timeliness**   | Prompt data entry   |
| **Accuracy**     | Verification review |
| **Consistency**  | Standardized coding |

## Best Practices

<AccordionGroup>
  <Accordion title="Train on Safety">
    Ensure all site staff understand safety reporting requirements.
  </Accordion>

  <Accordion title="Report Promptly">
    Enter safety data as soon as events are known.
  </Accordion>

  <Accordion title="Follow Up Diligently">
    Track events until resolution.
  </Accordion>

  <Accordion title="Review Regularly">
    Conduct regular safety data reviews.
  </Accordion>
</AccordionGroup>

## Related

<CardGroup cols={2}>
  <Card title="Protocol Compliance" icon="clipboard-check" href="/methodology/protocol-compliance">
    Protocol requirements for safety.
  </Card>

  <Card title="Questionnaire Templates" icon="file-lines" href="/templates/questionnaire-templates">
    Design safety questionnaires.
  </Card>
</CardGroup>