Practice · 1 October 2026
Before reusing a protocol, examine what changed later.
A discussion guide for comparing original protocols, amendments and the reasons actually documented.
Read the resource ↗Resources
Perspectives for
better protocol decisions.
Practical questions for protocol teams, alongside regulatory articles with links to official sources. Explore the design, evidence and assumptions behind the next decision.
Evaluate Tenvia at your own pace.
Explore the resources
Questions worth
bringing into review.
Discussion guides and regulatory perspectives. Each article keeps its sources and limitations in view.
10 resources
Practice · 1 October 2026
Bring the decision to the specialist who needs to review it.
Focus multidisciplinary review on decisions, evidence gaps and unresolved trade-offs while preserving the full protocol context.
Read the resource ↗Practice · 16 September 2026
Why is this test or procedure in the protocol?
A practical way to connect a test, procedure or questionnaire to its purpose, supporting evidence and the person responsible for deciding.
Read the resource ↗Practice · 16 September 2026
The assumptions behind the Schedule of Activities.
The Schedule of Activities lists what happens at each study visit. Record what must be checked before the team relies on that schedule.
Read the resource ↗Practice · 16 September 2026
One protocol question. Different review responsibilities.
Give each function the information it needs while keeping everyone focused on the same protocol decision.
Read the resource ↗Regulatory · 7 October 2026
A dose decision reaches across the protocol.
FDA’s open ibogaine consultation shows how dose selection, eligibility, monitoring and oversight become connected review questions.
Read the resource ↗Regulatory · 8 September 2026
Better regulatory conversations begin with the protocol.
What MHRA’s updated request process means for protocol questions, their supporting evidence and the professionals responsible for the response.
Read the resource ↗Regulatory · Updated 24 September 2026
What ICH M11 changes about protocol development.
The implications of structured protocol information for the people, requirements and systems involved in study delivery.
Read the resource ↗Regulatory · 1 October 2026
Shorter assessment timelines make protocol reasoning more important.
MHRA has expanded its Phase 1 programme. What should Sponsors and CROs keep clear about study context, evidence and accountable review?
Read the resource ↗Product · Updated 1 October 2026
Develop the protocol together. Keep the reasoning.
A concise overview for colleagues: historical amendment evidence, patient and site burden, focused specialist review and decision history.
Read the resource ↗Policy watch · EMA · 30 September 2026
Representative evidence begins with explicit protocol decisions.
EMA plans a women’s-health regulatory roadmap by the end of 2026, following its September workshop. Priorities include representation in trials and sex-disaggregated evidence.
Status: policy announcement, not effective guidance. The roadmap has not yet been published. No consultation deadline is stated.
Tenvia perspective: keep population assumptions and evidence gaps visible. This announcement alone does not establish a new protocol requirement or a new Tenvia capability.
Read EMA’s announcementEditorial principles
A clear distinction
between fact and interpretation.
Follow the official references in the article. Check the stated date, jurisdiction and publication status for the question you are reviewing.
Commentary does not establish regulatory acceptance, product compliance or submission readiness. It is not legal or regulatory advice.
Clinical and quality boundaries