Clinical Investigation and ISO 14155 Essentials Training by Tonex
Master the end-to-end lifecycle of clinical investigations with a pragmatic focus on ISO 14155 compliance, risk management, and documentation quality for medical devices and digital health. You will translate regulatory text into workable processes, templates, and controls that withstand sponsor, IRB/IEC, and authority scrutiny.
Security is now a clinical quality topic: connected devices, ePRO apps, and data platforms must be protected to prevent protocol deviations, data loss, or patient harm. You will learn how cybersecurity requirements intersect with safety risk, DPPs, and monitoring plans, and how to evidence these controls in TMF artifacts and inspection-ready narratives.
Learning Objectives
- Explain ISO 14155 structure, scope, and key definitions with confidence
- Build compliant clinical investigation plans, protocols, and monitoring frameworks
- Operationalize risk management, safety reporting, and quality documentation
- Align sponsor, investigator, CRO, and vendor roles for accountability
- Map data integrity and privacy controls to clinical workflows
- Integrate cybersecurity into safety risk, monitoring, and TMF evidence
- Prepare inspection-ready narratives, CAPAs, and continuous improvement loops
Audience
- Clinical project managers and study leads
- Regulatory and quality affairs professionals
- Medical device R&D and systems engineers
- Data managers and clinical operations specialists
- CRO and site management professionals
- Cybersecurity Professionals
- Compliance officers and auditors
Program Modules
Module 1 – ISO 14155 Framework Mastery
- Scope, terms, and normative references clarified
- Roles of sponsor, monitor, investigator aligned
- Ethics principles, IRB/IEC interactions streamlined
- CIP, CRF, and TMF document architecture
- Risk-based quality management foundations
- Inspection expectations and readiness mindset
Module 2 – Planning the Clinical Investigation
- Clinical evaluation linkage and justification
- Endpoints, estimands, and statistical thinking
- Inclusion, exclusion, and vulnerable populations
- Monitoring strategy and source data verification
- Vendor selection, oversight, and KPIs
- Budget, timelines, and feasibility gating
Module 3 – Conduct, Monitoring, and Control
- Site initiation, training, and role enablement
- IP accountability, randomization, and blinding
- Deviation handling and preventive controls
- Risk-based monitoring triggers and actions
- Safety event capture and expedited reporting
- Data integrity checks and audit trail reviews
Module 4 – Data, Privacy, and Cybersecurity
- eCRF, ePRO, and device telemetry pipelines
- GDPR, HIPAA, and cross-border transfer requirements
- Threat modeling for connected clinical systems
- Secure configurations, access, and segregation
- Incident response integrated with safety reporting
- TMF evidence for cybersecurity-related controls
Module 5 – Closing, Reporting, and Audits
- Database lock, analysis, and CSR alignment
- Clinical investigation report content and clarity
- TMF completeness, reconciliation, and archiving
- CAPA generation from findings and metrics
- Sponsor oversight reports and management review
- Authority queries, responses, and lessons learned
Module 6 – Practical Tools and Templates
- CIP outline, schedule, and authorship plan
- Risk register, ISO 14971 linkage, and heatmaps
- Monitoring plan, visit reports, and checklists
- Safety management plan and decision trees
- Data management plan and validation logs
- Inspection storyboards and briefing packages
Elevate your clinical program with ISO 14155 rigor and security-aware operations. Enroll now to gain actionable templates, audit-ready practices, and cross-functional fluency that accelerate compliant, high-quality evidence for your medical innovations.