Start with the right foundations.

Map the dependencies

Identify the sponsor, Nepal investigator, candidate sites, study functions and authority decisions. Distinguish documents that can be prepared in parallel from steps dependent on an approval or product permit. Record assumptions rather than treating an indicative schedule as an approval commitment.

Build a controlled start-up package

Keep a versioned checklist with a named owner and review status for each deliverable.

• Feasibility and site-selection evidence
• Investigator qualifications and institutional support
• Submission documents and participant materials
• Contracts, budgets and responsibility allocation
• Product, equipment and laboratory readiness
• Staff training and site-initiation records

Track review and authorization

Maintain the submitted versions, authority correspondence, responses and approval conditions. Ethics approval and product authorization are distinct, and institutional permissions must also be addressed. Verify registration and any permit requirements before the first participant is recruited. Check IRERP routing and NCTR registration through the official links in Resources.

Document the activation decision

Use a readiness review to verify that outstanding actions are resolved or formally accepted by the responsible parties. Confirm the approved protocol and consent versions, staff delegation, safety contacts, essential records and supply arrangements. Start-up coordination does not independently authorize a site to recruit.