Separate site interest, selection, approval, SIV completion, activation, and open-to-recruitment status so the team stops counting false capacity.
Problem Play
Startup Readiness Gap
Use the phase charter, site activation tracker, SIV readiness checklist, issue log, and critical-path schedule to prove the site can actually begin work.
What to do first
Check contract, budget, IRB/IEC approval, essential documents, systems access, supply, lab kits, training, delegation, and TMF filing against activation criteria.
Escalate if activation delay affects FPI/LPI, country strategy, high-enrolling sites, budget authority, protocol feasibility, or participant-facing commitments.
Expected output
Leave the first review with a named owner, dated action, evidence source, escalation threshold, and closure proof. If the issue affects participant protection, endpoint credibility, safety reporting, protocol compliance, critical path, budget authority, vendor scope, or inspection evidence, prepare a decision-ready escalation rather than a status update.