74 lines
1.3 KiB
Markdown
74 lines
1.3 KiB
Markdown
|
# Document Change Request Form
|
||
|
|
|
||
|
|
| Form ID | FRM-001 | Revision | 1.0 |
|
||
|
|
|---------|---------|----------|-----|
|
||
|
|
|
||
|
|
---
|
||
|
|
|
||
|
|
## 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) | | | |
|
||
|
|
|
||
|
|
---
|
||
|
|
|
||
|
|
*Form FRM-001 Rev 1.0*
|