Site start-up document review: every packet read and cross-checked before the green light
Every site packet read and cross-checked in under an hour, with one clear request for what is missing.
See one case, screen by screen ↓A site sends its start-up packet — the 1572, CVs, licences, GCP certificates, financial disclosures, the delegation log, the IRB approval, the consent form, lab certificate and ranges, the protocol signature page, the contract. Someone has to open every page and hold them against each other: is everyone with medical tasks on the delegation log also in Section 6 of the 1572? Does the approval name the current protocol version? Is anything going to expire before the first patient?
By hand, that review takes one to two days per packet, and it is easy to miss a mismatch that sits across two documents. Each miss is found later, asked for in a second or third email, and each extra round with the site costs about a week — while first patient in stays where it was.
Estimated split for one site’s start-up packet, in working hours, by hand and with the solution.
Six specialist agents sort, read, cross-check and chase every document; the start-up lead confirms each finding.
VLT-305 is a Phase 3 study of veltrimab in ulcerative colitis: 12 sites in 7 countries, first patient in targeted for Nov 16, 2026. At 07:40, site 104 in Austin uploads its start-up packet. Here is what happens next, screen by screen, in the working solution.
Lena opens the readiness board: 2 of 12 sites green-lit against a plan of 3 by today, 2 ready for her green light, 8 open findings across 4 sites. The board shows each site against the 12 document families, with every cell checked, a problem, expiring soon or not received. At the top of Needs you: Hill Country Digestive Research, a new packet with 23 documents to check.
“104 of 144 document families complete across 12 sites · 195 documents read by agents”
Mia Alvarez, the site’s coordinator, uploaded 23 documents through the site portal. Packet intake has already classified them into 12 document families, attached each one to the right person — Dr. Rafael Moreno, the PI, and his team — and noted the one expected document that did not arrive.
Lena presses Run checks. The field reader reads 61 pages and pulls 214 fields; three checkers run in parallel. The result: 42 of 46 checks passed and four findings. Dr. Kwame Mensah does medical tasks but is not on the Form FDA 1572. The IRB approval is for protocol 2.0 — the current version is 3.0. Dr. Hannah Lowe’s GCP certificate lapsed on Sep 12. The lab certificate expires 40 days after the planned activation.
“Checked in 64 seconds — 4 findings for you to confirm”
Each person on the delegation log sits in one row next to their 1572 entry and their CV, licence, GCP and disclosure. Dr. Mensah is delegated eligibility, consent and adverse-event assessment from Sep 22 — so he must be in Section 6, and he needs a signed financial disclosure that was never sent. The coordinator and the pharmacist have no medical tasks and are marked not needed.
Anyone with eligibility, examination or adverse-event tasks must be on the investigator statement.
Lena takes the suggested decisions: the first three go to the site. The CLIA certificate runs to Nov 30, 2026, short of the 90-day rule, but renewal is routine — she accepts it with a note and a reminder for Nov 1. A note needs a second approval, and Omar Haddad, the clinical operations director, approves it.
“Renewal is routine and not due before activation. Reminder set for Nov 1 to collect the renewed certificate.”
The fix-request writer drafts one message to Mia Alvarez, with Dr. Moreno and the CRA, Sam Patel, in copy: three numbered items — a revised 1572 adding Dr. Mensah to Section 6 with his financial disclosure, the IRB approval of Amendment 2 with the approved consent form 3.0, and a current GCP certificate for Dr. Lowe — due Oct 12. The accepted note is left out. Lena sends it through the site portal.
The agent drafts; a person sends.
Mia uploads five corrected documents. The agents keep the three older versions and mark them superseded, read the 9 new pages and confirm: Dr. Mensah is now in Section 6 and his disclosure is signed Oct 7; the IRB approved Amendment 2 on Oct 6 with consent 3.0; Dr. Lowe’s GCP certificate is dated Oct 6, 2026. 46 of 46 checks, 100 % ready.
“All clear — ready for your green light”
Lena gives the green light for site 104 with her name, her password and the meaning of the signature — “I approve activation of this site” — and confirms the essential records are complete and current. The signature is recorded with name, date, time and meaning. Every accepted document gets its TMF zone, section, site, person, date and version, and 24 documents go to the eTMF in Zones 04, 05 and 08. The depot is told it may ship VLT-305 kits to site 104, and Sam Patel is asked to book the initiation visit — two weeks ahead of the Oct 21 target.
“Green light · electronic signature — Lena Ortiz · Oct 7, 2026 at 10:58 · Meaning: I approve activation of this site”
Sites green-lit against plan, with a forecast from readiness; what the agents found, by type — delegation log and 1572 disagreeing leads with 9 in the last 30 days; days in each stage by site; and where findings come from, by country and document family.
The same packet, seen by the four people who carry it — what their week looked like, and what it looks like now.
Six specialist agents sort, read, cross-check and chase every document; the start-up lead confirms each finding.
Takes documents from the site portal and the start-up mailbox, classifies each into one of 12 document families, attaches it to the right site and person, and sets older versions aside.
Reads every page — scans, signatures and handwriting included — and pulls names, dates, signatures, versions, addresses, task codes and expiry dates, each with the passage it came from.
Lines up every person across the investigator statement, delegation log, CVs, licences, GCP certificates and financial disclosures, and explains each mismatch.
Compares approvals, consent forms and signature pages with the protocol version list, and every expiry date with the planned activation date plus the validity window.
Applies each country’s required document list — Form FDA 1572 in the US, the Qualified Investigator Undertaking in Canada, the investigator and site suitability forms in the EU — and reports what is missing or not acceptable.
Turns the confirmed findings into one clear request to the site coordinator, with the PI and CRA in copy — what to send, why, and by when — in English and, where the site prefers, its own language.
Confirms findings, signs the green light. The agents propose; a named person decides.
The start-up team can ask in plain words — or tell it what to change. Every answer shows the passage behind it.
What is blocking Hill Country from green light?
Four things, from the 23 documents that arrived at 07:40. Dr. Kwame Mensah is missing from the 1572: the delegation log gives him eligibility and adverse-event assessment, but Section 6 lists only two sub-investigators, and he also needs a financial disclosure. The IRB approval is for protocol 2.0 — current is 3.0. Dr. Hannah Lowe’s GCP certificate lapsed on Sep 12. The CLIA certificate ends Nov 30 — I suggest accepting with a note. The first three need the site.
Which sites can I green-light this week?
Two sites are ready, with nothing open: Lakeshore Gastroenterology Associates in Chicago, 46 checks passed, target Oct 14; and Klinikum Rheinaue in Leipzig, target Oct 16, with one note on Dr. Albrecht’s CV already approved by Omar Haddad.
Flag GCP certificates that lapse within 90 days of activation
Done. New check: GCP training must stay valid at least 90 days after the green light. Across the 12 packets it finds two people today: Dr. Hannah Lowe at Hill Country (lapsed Sep 12) and Dr. Marco Gallo at Ospedale San Lorenzo (lapses Nov 2). Both are already on their sites’ findings. The rule is in Settings and recorded in the audit trail.
Draft the fix request for Centrum Medyczne Odra
To Marta Lis, study coordinator, with Dr. Tomasz Wilk and Priya Raman in copy — two items on the delegation log: Dr. Ewa Kowalczyk’s start date is Sep 1, 2026, but her GCP certificate is dated Sep 15, 2026, so the start date needs correcting and initialling; and line 3, Dr. Paweł Sadowski, has no PI initials. Corrected log due Oct 12. The draft is on the site for you to send.
12 screens from the working solution, on its sample data. Pick one to see it large.
The checks follow your study plan and your country lists — and each one is a setting.
| Setting | Default | Choose from |
|---|---|---|
| CV age | 24 months | Months, set with − and + |
| GCP training within | 3 years | Years, set with − and + |
| Validity after activation (licences, lab certificates) | 90 days | Days, set with − and + |
| Medical tasks need the investigator statement · No task before training · Approvals name the current protocol · Lab ranges are complete | On | On · Off, each |
| Who gives the green light | Lena Ortiz | Lena Ortiz · Omar Haddad |
| Second approval to accept a finding with a note | Omar Haddad | Omar Haddad · Lena Ortiz |
| Where documents arrive | Site portal and start-up mailbox | Each on or off |
| Remind sites before a fix request is due | 2 days before, from the CRA’s address | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample study data · “target” = the design goal, measured in the live solution · “estimated” = our estimate of where the hours go · Context: Tufts CSDD start-up study · ICH E6(R3) essential records · 21 CFR 312.53. People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that reads each site’s start-up packet — the investigator statement, CVs, licences, GCP certificates, financial disclosures, delegation log, ethics approval, consent form, lab documents, protocol signature page and contract — and tells you what is missing, expired or inconsistent before the site is activated. Here six agents do the reading and cross-checking; the start-up lead confirms every finding.
The people cross-checker builds one row per person from the delegation log and the 1572. Anyone delegated eligibility, physical examination or adverse-event assessment must be in Section 1 or 6, and everyone there needs a CV, a licence, GCP training and a financial disclosure. Names must match, and no delegated task may start before training.
Yes. The version and expiry checker compares every IRB or ethics approval, consent form and protocol signature page with the protocol version list, and every expiry date with the planned activation date plus the validity window you set.
Each site is checked against its country’s list: Form FDA 1572 and the US list, the Qualified Investigator Undertaking in Canada, the investigator and site suitability forms in the EU. The lists, with their sources, are on the Requirements screen and change only with approval.
Yes. The agents propose findings; the start-up lead decides each one — ask the site, accept with a note, or not an issue. A note needs a second approval, the fix-request writer only drafts, and the green light is the start-up lead’s electronic signature.
The signature is recorded with name, date, time and meaning. Every accepted document is filed to the eTMF with its zone, section, site, person, date and version; the depot is told it may ship product; and the CRA is asked to book the initiation visit. The TMF owner samples the filing for quality control.
The Agentic Solution Engine builds and deploys it from your requirements — your country document lists, protocol versions, study dates and a sample of past site packets — and it goes live once every quality gate has passed. We will walk you through it on your own packets first.
A trial synopsis becomes a checked first-draft protocol in days, in your own approved language.
1-min filmTMF CheckEvery trial document is read, filed in the right place and checked, so the file is inspection-ready every day.
1-min filmCSR WriterResults sections and patient narratives are drafted within days of database lock, every number linked to its table.
1-min filmWe’ll run the Site Activation Essential-Documents Checker on a sample of your own start-up packets.