1.3 KiB
1.3 KiB
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