105 lines
2.1 KiB
Markdown
105 lines
2.1 KiB
Markdown
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# Training Record Form
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| Form ID | FRM-004 | Revision | 1.0 |
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---
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## Section 1: Employee Information
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| Field | Entry |
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|-------|-------|
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| Employee Name | |
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| Employee ID | |
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| Department | |
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| Job Title | |
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## Section 2: Training Information
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| Field | Entry |
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|-------|-------|
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| Training Title | |
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| Training Date | |
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| Training Duration | |
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| Trainer Name | |
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| Trainer Qualification | |
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### Training Type
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- [ ] Initial Training
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- [ ] Retraining
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- [ ] Refresher
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- [ ] Procedure Update
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- [ ] Protocol-Specific Training
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### Training Category
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- [ ] Good Clinical Practice (GCP)
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- [ ] Human Subject Protection
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- [ ] Pediatric Research Ethics (45 CFR 46 Subpart D)
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- [ ] Pediatric Safety Requirements (21 CFR 50 Subpart D)
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- [ ] ICH E11 Pediatric Guidelines
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- [ ] Pediatric Assent Process
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- [ ] Parental Permission
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- [ ] Age-Appropriate Communication
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- [ ] Child Development
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- [ ] Child Abuse Recognition and Reporting
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- [ ] Pediatric Procedures/Techniques
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- [ ] Study Protocol Training
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- [ ] Other: ____________
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### Delivery Method
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- [ ] Classroom
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- [ ] On-the-Job
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- [ ] Self-Study
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- [ ] Computer-Based
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- [ ] Simulation/Role-Play
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- [ ] Other: ____________
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## Section 3: Training Content
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*(List topics covered or attach training materials)*
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### Pediatric-Specific Content (if applicable)
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- Applicable age groups: [ ] Neonates [ ] Infants [ ] Children [ ] Adolescents
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- Special populations covered: ___________________________
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## Section 4: Assessment
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### Assessment Method
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- [ ] Written Test
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- [ ] Practical Demonstration
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- [ ] Verbal Assessment
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- [ ] Observation
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- [ ] Competency Checklist
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- [ ] Role-Play/Simulation (for assent discussions)
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### Assessment Results
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| Metric | Result |
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|--------|--------|
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| Score (if applicable) | |
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| Pass/Fail | |
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| Passing Score Required | 80% (or per protocol) |
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### Competency Achieved
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- [ ] Yes - Authorized to perform independently
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- [ ] No - Requires additional training/supervision
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### Next Retraining Due Date
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## Section 5: Signatures
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| Trainee | | | |
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| Trainer | | | |
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| Supervisor | | | |
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---
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*Form FRM-004 Rev 1.0*
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