Frequently Asked Questions
What is GHTRC researching?
How confidence in regulatory and clinical evidence is established, maintained, reassessed, strengthened, reduced, or challenged as evidence evolves throughout the health technology lifecycle.
Is GHTRC proposing continuous monitoring as a new requirement?
No. PMS, vigilance, clinical evaluation, QMS, regulatory monitoring, cybersecurity, and other lifecycle mechanisms already exist. Research examines how evidence changes affect earlier reliance and decisions.
Is GHTRC developing a new compliance framework?
Not at this stage. Any future approach should emerge only if justified by findings.
Is the research validating a product or technology?
No. It is independent of commercial products and predetermined technical solutions.
What does “confidence” mean?
The provisional working meaning is justified reliance on evidence for a particular decision at a particular time. It remains open to research and challenge.
Is confidence expected to become a numerical score?
Not necessarily. Measurement, proxies, and aggregation of stakeholder perspectives are research questions, not conclusions.
Who can participate?
Relevant researchers and professionals from regulatory, clinical, engineering, scientific, legal, governance, quality, technology, public-health, procurement, and related disciplines may apply.
What is the difference between roles?
Contributors actively research. Advisors provide independent subject-matter or methodological guidance. Observers follow research without an active assignment.
Must participants agree with the premise?
No. Critical, alternative, and contradictory perspectives are important.
Does participation guarantee authorship?
No. Authorship depends on actual contribution and applicable academic criteria.
Can developing research be followed?
Approved participants access materials appropriate to their roles and permissions. Working material, individual contributions, hypotheses, emerging findings, and validated or final outputs are distinguished.
Can a proposed methodology be challenged?
Yes. Methodologies, models, definitions, and hypotheses remain open to testing, comparison, refinement, or rejection.
What if existing systems are sufficient?
That is a legitimate outcome. Research may find current mechanisms adequate, identify implementation rather than regulation as the issue, or conclude no further intervention is needed.