# Corrective and Preventive Action (CAPA) Form

| Form ID | FRM-003 | Revision | 1.0 |
|---------|---------|----------|-----|

---

## Section 1: CAPA Identification

| Field | Entry |
|-------|-------|
| CAPA Number | |
| Date Initiated | |
| Initiated By | |
| CAPA Owner | |
| Target Closure Date | |

## Section 2: Classification

### Type
- [ ] Corrective Action
- [ ] Preventive Action

### Source
- [ ] Customer/Sponsor Complaint
- [ ] Internal Audit
- [ ] External Audit
- [ ] Sponsor Monitoring
- [ ] Protocol Deviation/Violation
- [ ] Adverse Event
- [ ] IRB/Ethics Committee Finding
- [ ] Participant/Family Concern
- [ ] Pediatric Safety Issue
- [ ] Nonconforming Product
- [ ] Management Review
- [ ] Other: ____________

### Priority
- [ ] Critical - Child Safety Risk (Immediate action required)
- [ ] Major (5 business days)
- [ ] Minor (15 business days)

## Section 3: Problem Description

*(Describe the nonconformity or potential nonconformity. For pediatric-related issues, include age group affected, number of participants impacted, and any safety implications.)*




## Section 4: Immediate Containment

*(Actions taken to contain the immediate impact, especially for child safety issues)*




## Section 5: Root Cause Investigation

### Investigation Method Used
- [ ] 5 Whys
- [ ] Fishbone Diagram
- [ ] Fault Tree Analysis
- [ ] Timeline Analysis
- [ ] Other: ____________

### Pediatric-Specific Factors Considered
- [ ] Age-appropriateness of procedures/materials
- [ ] Developmental considerations
- [ ] Family communication
- [ ] Parental permission/child assent process
- [ ] Pediatric dosing or procedures
- [ ] Child safety monitoring
- [ ] N/A

### Root Cause Determination




## Section 6: Corrective/Preventive Actions

| Action | Responsible | Due Date | Status |
|--------|-------------|----------|--------|
| | | | |
| | | | |
| | | | |

## Section 7: Notifications (if applicable)

- [ ] Principal Investigator notified
- [ ] Sponsor notified (Date: ______)
- [ ] IRB/Ethics Committee notified (Date: ______)
- [ ] FDA or other regulatory authority notified (Date: ______)
- [ ] Participants/families notified (Date: ______)
- [ ] DSMB notified (Date: ______)

## Section 8: Effectiveness Verification

| Criteria | Method | Result |
|----------|--------|--------|
| | | |

Verification Date: ____________
Verified By: ____________

## Section 9: Closure

| Role | Name | Signature | Date |
|------|------|-----------|------|
| CAPA Owner | | | |
| Quality Approval | | | |
| PI Approval (if study-related) | | | |

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*Form FRM-003 Rev 1.0*