Quality control and findings

Two levels of TMF quality control

Document-level QC asks whether one exact Document Version, classification revision, and metadata revision are complete, readable, correctly classified, correctly indexed, and acceptable for filing.

TMF-level QC asks whether all applicable evidence is present, correctly placed, timely, accessible, and sufficient to reconstruct conduct across the study, countries, sites, functions, and record locations.

Passing one does not imply passing the other.

QC criterion

A QC criterion is one governed question used to decide whether evidence is acceptable.

Field	Meaning
Criterion identifier and version	Exact approved definition
Plain-language question	For example, “Are all signed pages present and readable?”
Applies to	Record types, filing levels, copy types, risk classes, or TMF scopes
Evidence to examine	Content, metadata, classification, filing placement, approval, audit history, or external availability
Pass, fail, and not-applicable rules	Observable decision criteria
Default finding type and severity	Consequence of failure, subject to governed review
Blocking effect	Whether failure prevents finalization, filing, readiness, or archive
Effective period	When the criterion may be used

A published criterion version is not edited in place. A QC Round pins the exact criterion versions used.

QC request

A QC request assigns a defined review and explains why it is required.

Field	Meaning
Request identifier	Stable identity across rework rounds
Review scope	Exact Document Version plus proposed classification and metadata revisions, or a stated TMF population
Reason and risk basis	Routine, triggered, milestone, closeout, inspection preparation, or for-cause
Required criteria	Exact QC criterion versions and any approved sampling instruction
Requester, assignee, and due date	Accountability
Independence requirement	Whether the reviewer must differ from contributor, classifier, or approver
Status	Open, In Review, Rework Required, Ready for Another Round, Accepted, or Closed by Decision
Related Filing Slots or milestone	Operational impact

One QC request has one or more QC Rounds. A failed round does not disappear when rework begins.

QC round

A QC round is one completed review attempt against one exact evidence state.

Field	Meaning
QC request and round number	Sequence within the review request
Evidence reviewed	Exact Document Version, classification revision, metadata revision, and proposed filing placement, or exact TMF population snapshot
Reviewer	Person, role, and qualification
Started and completed dates	Review period
Criterion results	One result for every applicable required criterion
Overall result	Accepted, Accepted with Non-blocking Findings, or Rework Required
Findings	Deficiencies raised by this round
Supersedes	Earlier round after rework, without erasing it

A criterion result records Pass, Fail, or Not Applicable; evidence examined; observation; reviewer; time; and, for Not Applicable, the reason. Every required criterion has exactly one result in a completed round. A failed criterion that is material produces or links to a Quality Finding.

QC review evidence

Field	Meaning
Review scope	Document Version, Filing Slot, milestone, country, site, process, sample, or full TMF
Reason and risk basis	Routine, triggered, milestone, closeout, inspection preparation, or for-cause
Review criteria version	Exact approved checklist or procedure used
Reviewer and qualification	Who performed the review and under which role
Started and completed dates	Review period
Population and sample	What was eligible, selected, and excluded
Evidence examined	Exact versions, metadata, placements, audit history, or external locations
Result	Acceptable, Acceptable with Findings, or Unacceptable
Findings	Deficiencies raised from the review

This summary is derived from the QC Request, its QC Rounds, criterion results, and findings. It is not a replacement for them.

Document-level checks

correct study, country, site, and record type;
correct meaningful document date and version;
all pages, appendices, and signature components present;
readable text, signatures, handwriting, seals, and meaningful color;
required approval, certification, and authorship evidence;
correct confidentiality, privacy, and blinding classification;
correct relationship to original, translation, rendition, or superseded version;
acceptable duplicate assessment;
correct Filing Slot match;
content and metadata consistent with related trial facts.

TMF-level checks

every applicable due Filing Slot is resolved or visibly outstanding;
records are in the correct filing location and scope;
records were filed within the approved period;
superseded versions and implementation evidence support reconstruction;
essential correspondence includes the necessary conversation and attachments;
declared external record locations remain accessible and retrievable;
role access is appropriate, especially for unblinded and directly identifying records;
alterations, refiling, withdrawal, and corrections are traceable;
open findings and exceptions have accountable owners;
the TMF can be searched, retrieved, and understood without undocumented explanation.

Quality finding

Field	Meaning
Finding identifier	Stable identity
Finding type	Missing, Misfiled, Metadata, Illegible, Incomplete, Wrong Version, Duplicate, Expired, Untimely, Access, Audit Evidence, or Other governed type
Severity	Critical, Major, or Minor under an approved severity definition
Affected evidence	Exact Document Version, Filing Slot, scope, or record location
Description	Observable problem, not a vague judgement
Detected by and date	Attribution
Assignee and due date	Correction ownership
Immediate containment	Access restriction, quarantine, notification, or other protection
Root cause and broader impact	Required where the risk warrants it
Proposed and completed correction	What will change and what changed
Verification	Independent check where required
Outcome	Closed, Confirmed Non-Issue, or linked to an approved Exception Decision
Rationale and approval	Required for non-issue; exceptions use the separate Exception Decision and retain the finding

Status journey

Open → Assigned → Correction in progress → Ready for verification → Closed
          ├──────────────────────────────────────────────→ Confirmed non-issue
          └──────────────────────────────────────────────→ Governed by approved exception

“Corrected” is not the same as “verified.” An approved exception does not close or erase the observed deficiency; it records why and under which controls the unresolved condition is temporarily or permanently accepted. The person who makes a high-risk correction should not be the only person who confirms that it resolved the problem.

Findings and document status

The Filing Plan Revision defines which findings block finalization or continued use.

Examples that normally block finalization include:

wrong study or site;
missing required signature or page;
illegible content needed to understand the record;
a privacy or blinding breach;
absence of required certified-copy evidence;
content that contradicts its stated version or approval status.

A minor spelling correction in non-material metadata may follow an approved self-evident correction path. It still leaves the original value, corrected value, actor, date, reason, and verification evidence.

Approval and finalization are different

Content approval records a clinical, functional, regulatory, or management decision about the content.
QC acceptance confirms that the record meets the applicable TMF quality criteria.
Finalization makes that exact Document Version eligible to serve as authoritative TMF evidence.
Effectiveness records when the content begins to govern conduct, where applicable.

The same person may perform more than one role only when the Filing Plan Revision and risk controls permit it. The model records the role in which each decision was made.

Rework handoff

When QC rejects a version:

The failed QC Round and criterion result identify the exact version, classification, metadata, and problem.
The responsible contributor receives the finding and due date.
A content correction produces a new Document Version; a metadata or filing correction follows its own traceable route.
The original failed version remains linked to the finding.
Another QC Round verifies the corrected evidence against the pinned criteria.
Filing Slot matches and affected measures are recalculated without erasing the prior failure or delay.

Audit evidence

Retain the QC Request, each round, review scope, selection method, criterion versions and results, exact evidence reviewed, reviewer, timestamps, decision, findings, correction history, verification, signatures where required, and any approved exception. A checkbox saying “QC complete” is not sufficient evidence.