Inspection readiness

Readiness is an assessment, not a permanent label

An active study can be ready for inspection today and develop new gaps tomorrow when another record becomes due, an external location becomes unavailable, or a quality finding is opened. “Inspection Ready” should therefore be a dated conclusion about a defined scope, not a permanent Study TMF status.

Completeness alone is not readiness. An inspection-ready scope must also be understandable, accurately indexed, timely, readable, accessible, protected, and supported by traceable history.

Inspection readiness assessment

Field	Meaning
Assessment scope	Study, Country, Site, process, period, milestone, artifact group, or full TMF
Assessment date	Exact cut-off and time zone
Assessment reason	Routine, milestone, audit preparation, announced inspection, or for-cause
Filing Plan Revision	Approved instructions applied
Assessor and participants	Accountable persons and functions
Reference criteria	Approved readiness checklist or procedure version
Completeness evidence	Measure snapshot and detailed unresolved Filing Slots
Quality evidence	Open findings by severity, recent QC, systemic issues
Timeliness evidence	Late records and unresolved delays
Retrieval test	Search and retrieval cases, time taken, result
External-location test	Evidence that declared records remain directly retrievable
Access test	Confirmation of authorized, blinded, confidential, and read-only access
Audit-history test	Ability to reconstruct versions, corrections, filing, and decisions
Known limitations	Missing, unavailable, unreconciled, or poorly explained evidence
Conclusion	Ready, Ready with Declared Limitations, or Not Ready
Required actions	Owner, due date, and verification

The conclusion is refused when the scope is vague, critical content is unassessed, or the evidence used cannot be reproduced.

Readiness questions in TMF language

1. Can the inspector locate all applicable essential records for the stated scope?
2. Can the team explain why apparently missing records are Not Required or not yet due?
3. Do the correct Document Versions show the sequence of approvals, amendments, implementation, and oversight?
4. Can decisions and important communications be understood with their attachments and context?
5. Are sponsor, investigator/institution, and service-provider records available under the correct control?
6. Are unblinded, confidential, and directly identifying records protected while still retrievable by authorized people?
7. Can changes to content, metadata, classification, and filing be reconstructed?
8. Are source files, dynamic records, renditions, and certified copies usable and trustworthy?
9. Are open findings, late records, approved Exception Decisions, and missing evidence visible rather than concealed by metrics?
10. Can a person unfamiliar with the study understand the evidence without undocumented explanation?

Inspection request

Field	Meaning
Requesting authority or auditor	Who is requesting access
Legal or audit basis	Inspection, sponsor audit, due diligence, or other authorized purpose
Requested scope and period	Exact records, countries, sites, processes, and dates
Request and due times	Operational deadlines
Inspection contacts	Sponsor, TMF, quality, and technical coordinators
Clarifications	Questions, agreed interpretations, and scope changes
Status	Received, Clarifying, Preparing, Available, Closed

Disclosed record set

The records made available must be preserved as a defined set even while the active TMF continues to change.

Fields include:

• inspection request and scope;
• included TMF Documents and exact Document Versions;
• filing index and metadata as disclosed;
• included audit history;
• declared external records and retrieval route;
• excluded or redacted content and reason;
• generation time, checksum manifest, and preparer;
• later supplements or replacements with reason.

The disclosed record set is not a new authoritative TMF. It is evidence of what was provided at a specific time.

Controlled inspection access

Access is:

• read-only;
• limited to the agreed scope and time;
• restricted for blinding, participant privacy, legal privilege, and confidentiality;
• attributable to a named inspector, auditor, or authorized delegate;
• recorded with access time and materials viewed or exported where required;
• revoked when the approved period ends.

Providing access does not transfer record ownership. Sponsor personnel must not gain access to directly identifying investigator-controlled records merely because an inspection is underway.

Inspection during an active study

The eTMF must support continued controlled filing while preserving the disclosed record set.

1. Establish the inspection cut-off and disclosed scope.
2. Continue ordinary filing in the active TMF.
3. Identify later records relevant to the requested period.
4. Provide a governed supplement rather than silently changing the disclosed set.
5. Retain the reason, preparer, time, and exact additional versions.

Findings and follow-up

Inspection observations are not automatically internal Quality Findings. A responsible quality role classifies each observation, links it to affected evidence, records the regulatory response, and creates correction or preventive work where appropriate. Closing the inspection request does not close unresolved TMF findings.

Required refusals

• Refuse “Ready” when a Critical finding or inaccessible essential record remains unexplained.
• Refuse unrestricted or editable inspection access.
• Refuse silent removal or replacement of a disclosed Document Version.
• Refuse a readiness conclusion based only on a dashboard percentage.
• Refuse redaction that changes clinical meaning without visible explanation and retained source.
• Refuse to treat an inspection export as the new authoritative TMF.