Study start-up to close-out

Feasibility: test the assumptions

Compare the protocol with verified institutional capacity. Identify patient pathways, procedures, resources and the likely authority route. State the assumptions behind estimates and the evidence still needed. A feasibility recommendation is an input to a sponsor decision, not an approval.

Start-up: build the readiness record

Agree the scope, budget and responsibility allocation, assemble submission documents, and track authority and site permissions. Document training, product arrangements and required essential records. Activate a site only after the responsible parties confirm its readiness.

Conduct: coordinate and oversee

Use an agreed communication and monitoring plan to identify risks, resolve findings and document decisions. Keep investigator oversight and sponsor responsibilities explicit. Track protocol deviations, safety information, data queries and document changes through the study's authorized processes.

Change control: keep decisions aligned

When procedures, products, staff or sites change, assess the effect on approvals, participant information, contracts and training. Do not implement a change solely because a service provider has updated an operational document. Follow the applicable review requirements and urgent-hazard procedures.

Close-out: reconcile and transfer

Resolve outstanding queries and actions, reconcile investigational products or devices, verify essential records and document the handover. Identify ongoing safety follow-up and the people responsible for final reports, registry updates and results disclosure.

After close-out: retain access and accountability

Agree the record custodian, retention schedule and access arrangements under applicable requirements. Record who will respond to later authority inquiries or inspections. Completion of a monitoring visit does not end every sponsor or investigator obligation.

This guide is educational. It does not replace a protocol-specific decision by NHRC, DDA or the responsible institution. Qualified regulatory review remains required before publication.