Research Approach

GHTRC uses a staged, exploratory, multidisciplinary approach intentionally designed to avoid beginning with a predetermined solution.

Stage 1 — Literature and Existing-System Mapping

Review literature, regulatory requirements, standards, guidance, lifecycle-assurance approaches, clinical governance, post-market systems, and existing research to establish what is known and avoid presenting established practices as new gaps.

Stage 2 — International Stakeholder Engagement

Engage relevant disciplines and jurisdictions. Participants are encouraged to challenge the premise rather than confirm it.

Stage 3 — Structured Research

Assign questions according to expertise, stakeholder perspective, technology, and jurisdiction. The question bank is not a single questionnaire; researchers may investigate different components.

Stage 4 — Case Studies and Jurisdictional Analysis

Study selected jurisdictions and evidence-change scenarios to understand how lifecycle obligations and evidence-management processes operate in practice.

Stage 5 — Thematic and Comparative Analysis

Identify recurring themes, stakeholder and jurisdictional differences, evidence dependencies, failure points, successful practices, implementation gaps, unresolved questions, and areas requiring no additional intervention.

Stage 6 — Evaluation of Possible Approaches

Only where findings support it, evaluate principles, analytical methodologies, evidence models, governance approaches, conceptual frameworks, or decision-support methods. All remain open to criticism and comparison.

Stage 7 — Research Outputs

Outputs may include literature reviews, jurisdictional analyses, stakeholder studies, case studies, papers, conference outputs, peer-reviewed publications, and future empirical studies. Authorship and recognition reflect actual contribution.