Services / eTMF quality review

eTMF quality review

eTMF quality review

eTMF quality is not a green dashboard. It is whether the artifact that should exist for this milestone exists, is the right version, is identifiable to the study/site, and would survive an inspector reading it. CliniGene uses AI to pre-score inventory and documents. TMF specialists perform official QC and decide what is a miss vs. an allowed lag.

Contact us about this Email hello@clini-gene.com

The problem this process is built for

Completeness percentages hide empty placeholders, wrong-zone filings, and documents that fail QC (no date, no signature, wrong study ID). Teams export a Vault report, celebrate 90%, and then fail the first consent pull in the inspection room.

QC is expensive if every document is read by a person from scratch. It is reckless if nobody reads. The useful pattern is machine pre-check + human QC on a defined sample or on 100% of high-risk artifacts (consent, 1572/equivalent, IP, SAE, monitoring).

AI can classify, date-check, and detect obvious emptiness. It cannot decide that a late monitoring report is acceptable because of a documented exception — that is your TMF plan and your specialist.

What this has to survive

Day one, an inspector asks for a consent, a 1572/equivalent, a monitoring report, and an IP document. You should have path, QC status, and a person who can retrieve it in minutes — not a 90% dashboard.

Standards we score against

  • TMF Reference Model (or your sponsor index) and your TMF plan
  • Milestone expectations (SIV, FPI, LPLV, CSR, etc.)
  • ICH-GCP essential documents
  • Your TMF SOP, QC checklist, and quality metrics definition
  • Vault or other eTMF naming and country-pack rules

Where teams get stuck

  • Placeholder counted as complete
  • Duplicates and superseded versions still “current”
  • Site vs. sponsor artifacts mixed or missing at one level
  • QC comments in email, not in a reopenable log
  • No punch list owners; the same gaps return next quarter

Who it is for

TMF managers, clinical operations, QA, and study leads who need a defensible completeness and quality picture before audit, lock, or submission-adjacent milestones.

What AI does — and does not do

On eTMF work, AI reconciles expected vs. actual, pre-scores identity/dating, and clusters QC themes. TMF specialists issue official QC and decide allowed lag vs. a miss. AI drafts maps, flags, first-pass language, and punch lists. A named specialist accepts, edits, or dismisses every official finding. AI does not sign a quality record, approve a vendor, freeze Vault, or speak in an inspection.

Questions on fit? hello@clini-gene.com or the contact form.

When to start this process

Start before LPLV, CSR, or a known inspection window — especially when completeness is a high percentage with heavy placeholders. Also start after a CRO handover when you do not trust the dashboard.

Pair this with GCP readiness when an inspection is near: eTMF is the file; GCP is the clause and quality-system story.

What this is not

  • Replacing your TMF manager or owning the vault
  • Moving documents without your recode/replace procedure
  • Counting placeholders as complete to improve a slide
  • Official QC performed only by the model
AI in this process

How the model is used, layer by layer

Each layer has a human gate. AI does not write the official quality record.

Expected vs. actual

From the TMF plan and milestone, AI builds the expected list and reconciles the inventory export. Placeholders and “expected later” are called out separately from collected.

Identity and dating

Study/site IDs, document dates vs. event dates, obvious unsigned or 0-byte files. Specialists still do official QC.

Classification assist

Suggested zone/section when a document is in the wrong place. People move it under your procedure.

Theme clustering

The same QC fail at many sites — unsigned DoA, late MVR, country-pack incomplete — so operations can fix the intake process.

Inspection-first shortlist

The artifacts an inspector will ask for on day one, with path and QC status, so the war room is not a search party.

Re-score loop

Only changed artifacts are re-checked so the metric moves with evidence.

Want this process walked on your trial or system?

Send the study, Vault, vendor, or inspection window. We will say what we need and what a first pass looks like.

hello@clini-gene.com

Contact form Email the team
End-to-end process

Step-by-step: from intake to re-check

  1. 1

    Lock the plan and the cut date

    Which TMF plan version, which milestone, 100% vs. sample QC, and which artifact types are always 100% (usually consent and investigator).

  2. 2

    Export the inventory

    Vault or other eTMF. Agree what “collected” means in your report (placeholder ≠ collected).

  3. 3

    Completeness reconcile

    Expected vs. actual. Output is a list, not only a percentage.

  4. 4

    QC pass

    AI pre-score then specialist QC per your checklist. Fail reasons are coded so themes are real.

  5. 5

    Theme and ops feedback

    Intake, site, or CRO process changes — not only “please refile.”

  6. 6

    Dashboard and shortlist

    % expected collected, % QC passed, placeholder aging, inspection-first list.

  7. 7

    Punch list with owners

    Each miss has a name and a date. We do not leave a 400-row spreadsheet with no owner.

  8. 8

    Re-check

    On re-upload, re-score those rows. Report the delta.

What a typical engagement looks like

Setting. Typical: eTMF in Vault, LPLV approaching, completeness 88% with heavy placeholders, inspection possible in a quarter.

What we do. Reconcile to the TMF plan, 100% QC on consent/investigator/IP/safety, sample QC on the rest, theme report to the CRO, punch list, re-check two weeks later.

What you can show. You can say what is actually collected, what failed QC, and what an inspector will see first — with owners.

Time

A single-study completeness + risk-based QC pass is often 3–8 weeks. Ongoing QC as a service is monthly or per milestone.

How a typical calendar runs

  1. Week 0. Lock TMF plan version, milestone, cut date, 100% vs. sample QC, always-100% types (usually consent and investigator).
  2. Week 1. Inventory export. Define “collected” (placeholder ≠ collected). Expected list built.
  3. Week 2–4. Completeness reconcile. AI pre-score. Specialist QC. Fail reasons coded.
  4. Week 4–5. Theme report to ops/CRO. Inspection-first shortlist. Punch list with owners and dates.
  5. Week 5–8. Re-check only changed rows. Report the delta. Repeat monthly or per milestone if engaged that way.

What we need from you

  • TMF plan and index / expected list
  • eTMF inventory export
  • QC checklist and metric definitions
  • Milestone and in-scope countries/sites
  • Who may recode or replace documents

You receive

  • Expected-vs-actual completeness report (placeholders separated)
  • QC finding log with reviewer confirmation
  • Theme report for clinical ops / CRO
  • Inspection-first artifact shortlist with paths
  • Owned punch list and re-check delta

Questions we hear first

Do you replace our TMF manager?
No. We add a quality-review process and a punch list. Your TMF owner still owns the vault.
Can AI read every PDF?
It can pre-check many. Official QC is human. Scanned poor-quality files may need a person first.
How is this different from GCP audit readiness?
eTMF review is the file. GCP readiness is the quality system and clause map. They share exports and should be planned together when an inspection is near.
What completeness number do you report?
We report expected collected, placeholders, QC-passed, and aging — separately. A single percentage is a management view, not the inspection view.
Do you recode documents in Vault?
Only if your procedure and access allow it. Default is a punch list your TMF owner executes.
Can this run every month?
Yes. Ongoing QC is usually monthly or per milestone, re-scoring only what changed plus a rotating sample.

Start with eTMF quality review

Email hello@clini-gene.com or use the form. Mention eTMF quality review so we route it correctly.

hello@clini-gene.com

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Talk with us about eTMF quality review

Email hello@clini-gene.com or send this form. The process is already selected.

Tell us the trial, Vault, vendor, or inspection date and what “done” looks like.

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