Inspection Readiness Checklist

Governance and responsibilities

• Are sponsor, CRO, vendor, and functional responsibilities documented and current?
• Are decision rights and escalation pathways understood by the working team?
• Do governance meetings produce clear decisions, owners, and target dates?
• Can the sponsor demonstrate active oversight of outsourced activities?

Risk and issue management

• Is the risk register current and connected to actual study activity?
• Are material issues classified, escalated, and tracked through closure?
• Are root cause and corrective actions proportionate to the issue?
• Is CAPA effectiveness evaluated and documented?
• Are recurring signals reviewed across sites, countries, and vendors?

Essential records and TMF health

• Is there a current list of expected essential records and owners?
• Are records filed within defined timelines?
• Are completeness and quality reviews performed on a risk-based cadence?
• Are operational trackers reconciled with the TMF?
• Are missing or late records assigned for remediation?

Medical and safety oversight

• Are medical review responsibilities and response pathways defined?
• Are eligibility, protocol, and safety questions documented appropriately?
• Are interfaces between medical monitoring, pharmacovigilance, clinical operations, and sites clear?
• Can significant medical decisions be reconstructed from the record?

Vendor oversight

• Are performance measures connected to meaningful thresholds and action?
• Are governance records complete and decisions traceable?
• Are vendor recovery plans monitored for delivery and effectiveness?
• Are cross-vendor dependencies visible to the sponsor?

Readiness review

• Can the team explain the study’s major risks and how they were controlled?
• Are key personnel prepared to describe their responsibilities and oversight?
• Are document requests routed, tracked, quality checked, and fulfilled consistently?
• Have known gaps been prioritized by participant, data, and compliance risk?

This checklist is a general operational resource, not legal or regulatory advice. The review approach should be adapted to the protocol, applicable requirements, sponsor procedures, and inspection context.