# Standard Operating Procedure: Training and Competence

| Document ID | SOP-003 |
|-------------|---------|
| Title | Training and Competence |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Human Resources / Quality |

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## 1. Purpose

To ensure personnel performing work in pediatric clinical research are competent based on appropriate education, training, skills, and experience, with specific emphasis on pediatric research requirements and child protection.

## 2. Scope

This procedure applies to:
- All employees performing pediatric research activities
- Principal Investigators and sub-investigators
- Study coordinators and research nurses
- Contractors and temporary personnel
- Personnel requiring GCP and pediatric-specific training
- Personnel interacting with child participants and families

## 3. Responsibilities

### 3.1 Supervisors/Managers
- Identify training needs for their personnel
- Ensure pediatric-specific competencies are met
- Ensure training completed before performing tasks with children
- Evaluate competence of personnel
- Maintain department training records

### 3.2 Human Resources
- Coordinate training programs
- Maintain central training database
- Track training compliance
- Verify credentials and licenses
- Archive training records

### 3.3 Quality Assurance
- Develop QMS-related training
- Approve training curricula for pediatric research activities
- Monitor pediatric research competency requirements
- Audit training compliance
- Ensure GCP and pediatric-specific training current

### 3.4 Principal Investigator
- Ensure study team adequately trained for pediatric research
- Verify protocol-specific training completion
- Assess ongoing competence
- Document delegation of duties

### 3.5 Employees
- Complete assigned training on time
- Maintain current qualifications and certifications
- Report training needs to supervisor
- Maintain GCP certification
- Complete pediatric research ethics training

## 4. Procedure

### 4.1 Training Needs Assessment

1. Identify competence requirements for each role:
   - Educational background
   - Professional licenses/certifications
   - Required training courses
   - Pediatric experience requirements

2. Document requirements in job descriptions

3. Assess current competence of personnel

4. Identify training gaps

5. Develop training plan addressing:
   - General QMS training
   - GCP training
   - Pediatric research-specific training
   - Protocol-specific training
   - Child protection and safety

### 4.2 Core Training Requirements

All personnel involved in pediatric clinical research must complete:

#### 4.2.1 Foundational Training
- Good Clinical Practice (GCP) - ICH E6(R2)
- Human Subject Protection (HSP)
- HIPAA and privacy regulations
- 21 CFR Part 11 (if applicable)

#### 4.2.2 Pediatric-Specific Training
- **45 CFR 46 Subpart D**: Additional Protections for Children
- **21 CFR 50 Subpart D**: Additional Safeguards for Children
- **ICH E11**: Pediatric Clinical Investigations
- Pediatric assent process
- Parental permission requirements
- Age-appropriate communication techniques
- Child development basics
- Child abuse recognition and reporting
- Pediatric adverse event assessment

#### 4.2.3 Role-Specific Training
- Protocol-specific procedures
- Study drug/device administration (pediatric dosing)
- Pediatric phlebotomy (if applicable)
- Medical monitoring for pediatric populations
- Regulatory submissions for pediatric studies
- Data management for pediatric trials

### 4.3 Training Curriculum Development

1. Define learning objectives appropriate for pediatric research

2. Develop training materials including:
   - Pediatric research regulations
   - Age-appropriate study techniques
   - Child-family interaction skills
   - Case studies and scenarios

3. Identify delivery method:
   - Classroom/interactive sessions
   - On-the-job training with experienced personnel
   - Self-study modules
   - Computer-based training
   - Simulation/role-play (for assent discussions)

4. Define assessment criteria

5. Obtain approval from Quality (for GCP/pediatric training)

### 4.4 Training Delivery

1. Schedule training session

2. Document attendance with:
   - Employee name and ID
   - Training title and date
   - Trainer name and qualifications
   - Training duration

3. Deliver training per curriculum

4. Assess comprehension through:
   - Written test (minimum 80% passing)
   - Practical demonstration (e.g., assent discussion)
   - Supervisor observation
   - Competency checklist completion

5. For hands-on pediatric procedures:
   - Observed practice before independent performance
   - Competency assessment by qualified trainer
   - Documentation of proficiency

### 4.5 Training Documentation

Training records shall include:
- Employee name, position, and ID number
- Training title, description, and objectives
- Training date and location
- Trainer name and qualifications
- Training materials version
- Assessment method and results
- Pass/fail determination
- Signatures (trainer and trainee)
- Remediation if applicable

### 4.6 Retraining Requirements

Retraining is required when:
- Significant document revisions occur (especially consent/assent forms)
- Performance deficiencies identified
- Extended absence from pediatric research functions (>12 months)
- Periodic requalification due:
  - GCP certification: Every 3 years
  - Pediatric research ethics: Every 3 years
  - Protocol-specific: Per protocol requirements or annually
- Regulatory changes affecting pediatric research
- Corrective action plans require retraining

### 4.7 New Employee Orientation

All new employees involved in pediatric research shall complete:

1. **Day 1-3**: Company orientation
   - Company mission and values
   - Organizational structure
   - Facilities and safety

2. **Week 1**: Quality system and regulatory training
   - Quality Management System overview
   - Document control and CAPA
   - GCP and Human Subject Protection
   - Privacy and confidentiality

3. **Week 1-2**: Pediatric research-specific training
   - Pediatric research regulations (45 CFR 46 Subpart D, 21 CFR 50 Subpart D)
   - ICH E11 guidelines
   - Assent and parental permission processes
   - Age-appropriate communication
   - Child safety and abuse reporting

4. **Ongoing**: Job-specific training
   - SOP read and understand for applicable procedures
   - Protocol-specific training
   - Supervised practice before independent work
   - Competency assessments

### 4.8 Principal Investigator Requirements

Principal Investigators must demonstrate:
- Medical degree or equivalent qualification
- Board certification in relevant specialty (pediatrics, pediatric subspecialty)
- Active state medical license
- Current GCP certification
- Pediatric clinical experience
- Prior research experience (preferred)
- Training in pediatric research ethics
- No regulatory sanctions or clinical privileges restrictions

### 4.9 Study Coordinator Requirements

Study Coordinators must demonstrate:
- Nursing degree or equivalent healthcare background (preferred)
- Current professional license (if applicable)
- GCP certification
- Pediatric research training
- Experience working with children and families
- Protocol-specific training
- Competency in age-appropriate communication

### 4.10 Verification of Training

1. Human Resources verifies completion before research activities begin

2. Principal Investigator reviews study team training status

3. Quality Assurance audits training compliance

4. Sponsor monitors review training records during site visits

5. Training records available for regulatory inspection

## 5. Competency Assessment

### 5.1 Initial Competency
- Written assessment (minimum 80% correct)
- Practical demonstration of skills
- Observed interactions with mock participants (families/children)
- Completion of competency checklist

### 5.2 Ongoing Competency
- Annual performance reviews
- Observation of pediatric procedures
- Audit findings review
- Protocol deviation trends
- Feedback from participants/families

### 5.3 Remediation
- Additional training if competency not demonstrated
- Supervised practice with experienced personnel
- Reassessment after remediation
- Documentation of successful completion

## 6. Training Records Retention

- Training records maintained for duration of employment plus 3 years
- Study-specific training records maintained per protocol requirements
- GCP certificates maintained with personnel files
- Records available for regulatory inspection
- Electronic records maintained per 21 CFR Part 11 if applicable

## 7. Special Pediatric Populations

Additional training may be required for:
- Neonatal intensive care research
- Pediatric oncology
- Rare pediatric diseases
- Emergency research in children
- Adolescent reproductive health research
- Research with decisionally impaired children

## 8. Related Documents

- FRM-004 Training Record Form
- FRM-005 Training Assessment Form
- FRM-PED-001 Pediatric Competency Checklist
- Job Descriptions
- Delegation of Authority Log

## 9. References

- ICH-GCP E6(R2) Section 5.18 (Investigator and Institution)
- 45 CFR 46 Subpart D (Additional Protections for Children)
- 21 CFR 50 Subpart D (Additional Safeguards for Children)
- 21 CFR 312.53 (Selecting Investigators and Monitors)
- ICH E11 (Pediatric Clinical Investigations)

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |