# Training Record Form

| Form ID | FRM-004 | Revision | 1.0 |
|---------|---------|----------|-----|

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## Section 1: Employee Information

| Field | Entry |
|-------|-------|
| Employee Name | |
| Employee ID | |
| Department | |
| Job Title | |

## Section 2: Training Information

| Field | Entry |
|-------|-------|
| Training Title | |
| Training Date | |
| Training Duration | |
| Trainer Name | |
| Trainer Qualification | |

### Training Type
- [ ] Initial Training
- [ ] Retraining
- [ ] Refresher
- [ ] Procedure Update
- [ ] Protocol-Specific Training

### Training Category
- [ ] Good Clinical Practice (GCP)
- [ ] Human Subject Protection
- [ ] Pediatric Research Ethics (45 CFR 46 Subpart D)
- [ ] Pediatric Safety Requirements (21 CFR 50 Subpart D)
- [ ] ICH E11 Pediatric Guidelines
- [ ] Pediatric Assent Process
- [ ] Parental Permission
- [ ] Age-Appropriate Communication
- [ ] Child Development
- [ ] Child Abuse Recognition and Reporting
- [ ] Pediatric Procedures/Techniques
- [ ] Study Protocol Training
- [ ] Other: ____________

### Delivery Method
- [ ] Classroom
- [ ] On-the-Job
- [ ] Self-Study
- [ ] Computer-Based
- [ ] Simulation/Role-Play
- [ ] Other: ____________

## Section 3: Training Content

*(List topics covered or attach training materials)*




### Pediatric-Specific Content (if applicable)
- Applicable age groups: [ ] Neonates [ ] Infants [ ] Children [ ] Adolescents
- Special populations covered: ___________________________


## Section 4: Assessment

### Assessment Method
- [ ] Written Test
- [ ] Practical Demonstration
- [ ] Verbal Assessment
- [ ] Observation
- [ ] Competency Checklist
- [ ] Role-Play/Simulation (for assent discussions)

### Assessment Results

| Metric | Result |
|--------|--------|
| Score (if applicable) | |
| Pass/Fail | |
| Passing Score Required | 80% (or per protocol) |

### Competency Achieved
- [ ] Yes - Authorized to perform independently
- [ ] No - Requires additional training/supervision

### Next Retraining Due Date


## Section 5: Signatures

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Trainee | | | |
| Trainer | | | |
| Supervisor | | | |

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*Form FRM-004 Rev 1.0*