117 lines
2.5 KiB
Markdown
117 lines
2.5 KiB
Markdown
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# Corrective and Preventive Action (CAPA) Form
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| Form ID | FRM-003 | Revision | 1.0 |
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---
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## Section 1: CAPA Identification
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| Field | Entry |
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|-------|-------|
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| CAPA Number | |
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| Date Initiated | |
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| Initiated By | |
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| CAPA Owner | |
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| Target Closure Date | |
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## Section 2: Classification
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### Type
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- [ ] Corrective Action
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- [ ] Preventive Action
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### Source
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- [ ] Customer/Sponsor Complaint
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- [ ] Internal Audit
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- [ ] External Audit
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- [ ] Sponsor Monitoring
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- [ ] Protocol Deviation/Violation
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- [ ] Adverse Event
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- [ ] IRB/Ethics Committee Finding
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- [ ] Participant/Family Concern
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- [ ] Pediatric Safety Issue
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- [ ] Nonconforming Product
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- [ ] Management Review
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- [ ] Other: ____________
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### Priority
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- [ ] Critical - Child Safety Risk (Immediate action required)
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- [ ] Major (5 business days)
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- [ ] Minor (15 business days)
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## Section 3: Problem Description
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*(Describe the nonconformity or potential nonconformity. For pediatric-related issues, include age group affected, number of participants impacted, and any safety implications.)*
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## Section 4: Immediate Containment
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*(Actions taken to contain the immediate impact, especially for child safety issues)*
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## Section 5: Root Cause Investigation
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### Investigation Method Used
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- [ ] 5 Whys
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- [ ] Fishbone Diagram
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- [ ] Fault Tree Analysis
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- [ ] Timeline Analysis
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- [ ] Other: ____________
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### Pediatric-Specific Factors Considered
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- [ ] Age-appropriateness of procedures/materials
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- [ ] Developmental considerations
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- [ ] Family communication
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- [ ] Parental permission/child assent process
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- [ ] Pediatric dosing or procedures
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- [ ] Child safety monitoring
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- [ ] N/A
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### Root Cause Determination
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## Section 6: Corrective/Preventive Actions
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| Action | Responsible | Due Date | Status |
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|--------|-------------|----------|--------|
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## Section 7: Notifications (if applicable)
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- [ ] Principal Investigator notified
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- [ ] Sponsor notified (Date: ______)
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- [ ] IRB/Ethics Committee notified (Date: ______)
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- [ ] FDA or other regulatory authority notified (Date: ______)
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- [ ] Participants/families notified (Date: ______)
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- [ ] DSMB notified (Date: ______)
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## Section 8: Effectiveness Verification
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| Criteria | Method | Result |
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|----------|--------|--------|
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Verification Date: ____________
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Verified By: ____________
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## Section 9: Closure
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| CAPA Owner | | | |
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| Quality Approval | | | |
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| PI Approval (if study-related) | | | |
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---
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*Form FRM-003 Rev 1.0*
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