74 lines
1.3 KiB
Markdown
74 lines
1.3 KiB
Markdown
# Document Change Request Form
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| Form ID | FRM-001 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Section 1: Request Information
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| Field | Entry |
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|-------|-------|
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| Request Date | |
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| Requested By | |
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| Department | |
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## Section 2: Document Information
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| Field | Entry |
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|-------|-------|
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| Document Number | |
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| Document Title | |
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| Current Revision | |
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## Section 3: Change Description
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### Type of Change
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- [ ] New Document
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- [ ] Revision to Existing Document
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- [ ] Document Obsolescence
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### Description of Change
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*(Describe the proposed change in detail)*
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### Reason for Change
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*(Explain why this change is needed)*
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## Section 4: Impact Assessment
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### Affected Areas
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- [ ] Training Required
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- [ ] Other Documents Affected
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- [ ] Process Changes Required
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- [ ] Validation Impact
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- [ ] IRB/Ethics Committee Approval Required
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- [ ] Informed Consent/Assent Forms Affected
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- [ ] Pediatric Safety Considerations
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- [ ] Age-Appropriateness Review Needed
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### List Affected Documents
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### Impact on Active Pediatric Studies
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*(If applicable, describe impact on ongoing studies)*
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## Section 5: Approvals
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| Requester | | | |
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| Document Owner | | | |
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| Quality Assurance | | | |
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| Pediatric Specialist (if applicable) | | | |
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---
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*Form FRM-001 Rev 1.0*
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