Curriculum
- 6 Sections
- 26 Lessons
- 1 Day
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- Foundations of Clinical Investigation & ISO 14155 Framework4
- 1.1Clinical investigation, sponsor responsibilities, Good Clinical Practice (GCP), Declaration of Helsinki, ISO 14155 scope.
- 1.2Patient safety first, Ethical compliance, Evidence generation
- 1.3Case Based Learning: Inadequate clinical design led to device market rejection
- 1.4Exercise: Identify key stakeholders and their responsibilities in a sample study design
- Clinical Investigation Planning & Design5
- 2.1Clinical Investigation Plan (CIP), protocol development, device classification impact, endpoints selection, risk-benefit analysis.
- 2.2Nuances: Feasibility studies vs pivotal trials, pilot vs confirmatory studies
- 2.3Essential requirements, Scientific validity, Risk-based approach
- 2.4Example: Comparison of study designs between EU MDR and FDA IDE submissions
- 2.5Draft a mock outline of a CIP for a new Class II device
- Conducting the Clinical Investigation5
- 3.1Subject protection, informed consent, monitoring, data integrity, adverse event reporting, documentation
- 3.2Nuances: CRO involvement, site selection, investigator responsibilities
- 3.3Data integrity, Vigilance, Case Report Forms (CRFs)
- 3.4Case based Learning: Clinical trial halted due to inadequate adverse event reporting
- 3.5Exercise: Review a mock adverse event log and decide escalation actions
- Managing Quality, Compliance & Ethics4
- 4.1Focus: Risk management, monitoring, auditing, deviations handling, ethical oversight (EC/IRB role)
- 4.2Audit trail, Protocol deviation, Data credibility
- 4.3Case based learning: Ethics committee rejection due to insufficient risk-benefit justification
- 4.4Exercise: Analyze a protocol deviation scenario and propose corrective actions
- Reporting, Documentation & Post-Investigation Activities4
- 5.1Clinical Investigation Report (CIR), publication standards, regulatory submissions, post-market clinical follow-up (PMCF).
- 5.2Transparency, Traceability, Regulatory readiness
- 5.3Case based learning: Delayed market approval due to incomplete CIR
- 5.4Draft a summary of a mock clinical investigation report for submission
- Interactive Case Study4
Manage mid-study adverse events and deviations
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