1. Examine the concept of confidence

Determine whether confidence in regulatory and clinical evidence is a meaningful research construct and how stakeholders understand it.

2. Map existing lifecycle mechanisms

Examine how existing regulatory, clinical, quality, post-market, vigilance, cybersecurity, governance, and information-management mechanisms maintain or reassess evidence.

3. Identify evidence-changing events

Investigate which lifecycle events can materially affect evidence previously relied upon.

4. Examine awareness

Understand how stakeholders become aware of relevant events and how the date and source of awareness are established.

5. Examine evidence dependency

Determine whether later changes can be traced to devices, regulatory entries, clinical or procurement decisions, organisations, or stakeholders that relied upon the original evidence.

6. Examine impact assessment

Investigate how organisations determine whether an event materially affects earlier decisions.

7. Examine communication and governance

Explore responsibility for detection, assessment, escalation, communication, action, and closure.

8. Compare jurisdictions and stakeholder groups

Identify similarities and differences between regulatory systems, healthcare environments, technologies, and professional perspectives.

9. Test whether a genuine research gap exists

Determine whether problems are conceptual, regulatory, implementation, information-management, organisational, interoperability, or governance gaps—or are already adequately addressed.

10. Allow outcomes to emerge from evidence

Only if supported by research should later work consider principles, analytical methods, conceptual models, or other approaches.