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SOPs/SOP-003-Training.md

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+# 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 |
+
+---
+
+## 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)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |