# Document Change Request Form

| Form ID | FRM-001 | Revision | 1.0 |
|---------|---------|----------|-----|

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## Section 1: Request Information

| Field | Entry |
|-------|-------|
| Request Date | |
| Requested By | |
| Department | |

## Section 2: Document Information

| Field | Entry |
|-------|-------|
| Document Number | |
| Document Title | |
| Current Revision | |

## Section 3: Change Description

### Type of Change
- [ ] New Document
- [ ] Revision to Existing Document
- [ ] Document Obsolescence

### Description of Change
*(Describe the proposed change in detail)*




### Reason for Change
*(Explain why this change is needed)*




## Section 4: Impact Assessment

### Affected Areas
- [ ] Training Required
- [ ] Other Documents Affected
- [ ] Process Changes Required
- [ ] Validation Impact
- [ ] IRB/Ethics Committee Approval Required
- [ ] Informed Consent/Assent Forms Affected
- [ ] Pediatric Safety Considerations
- [ ] Age-Appropriateness Review Needed

### List Affected Documents


### Impact on Active Pediatric Studies
*(If applicable, describe impact on ongoing studies)*


## Section 5: Approvals

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Requester | | | |
| Document Owner | | | |
| Quality Assurance | | | |
| Pediatric Specialist (if applicable) | | | |

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*Form FRM-001 Rev 1.0*