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CLINICAL ENDPOINT ADJUDICATION PACKETS

The committee must stay blinded. The packet has to make that true.

Clinical endpoint adjudication packet services build the blinded event dossiers a CEC reviews: source documents redacted to the charter's blinding rules, ordered chronologically, and page-cited throughout. The committee adjudicates the endpoint; the assembly and redaction stop being the trial's critical path.

Click any row → the source page it cites
Event packet · Case #IME-4812 documented
Adams, Timothy · suspected endpoint event
342 pp / 2 packets received logged
11 duplicate pages removed free
p.140 — wrong patient quarantined
Pages 342 Documents 27 Cited 100%

The charter is written. So is the committee that applies it.

We do not build for a case type until we can name the standard that defines a correct output and the person who grades the file against it. In endpoint adjudication, both are already written.

The standard and the referee
The rulebook
  • The adjudication charter, which defines the endpoint definitions, the required source documents, and exactly what must be redacted to preserve blinding
  • ICH E6 Good Clinical Practice, which governs source data, documentation and the trial's quality system
  • 21 CFR Part 11, where the packets and the adjudication decisions live in a validated electronic system
  • The protocol's own endpoint definitions, which the charter operationalizes
The referee
  • The Clinical Endpoint Committee, whose blinded adjudication is the outcome of record
  • The sponsor's quality assurance function and the trial's independent monitors
  • The regulator at review, where an unblinded or incomplete packet undermines the endpoint data
Coordinator hours per event assembling and redacting source documents by hand Flat 10¢/page here, duplicates free
Event packet · Case #IME-4812 cited 100%
Packet342 pp / 2 packets · 11 deduplicatedlogged
Source documentsOrdered to the event timelinecited
Blinding redactionsApplied per the charter, loggedredacted
Missing sourceCharter-required document absentflagged
Packet delivered · cited 100% · no adjudication
How it works

3 steps between the site documents and the committee.

01

Send the source documents

Hospital records, imaging, ECGs, laboratory reports and site narratives for the suspected event, in any format and any language of origin.

02

We return the packet, redacted and page-cited

Documents ordered to the event timeline, redacted to the charter's blinding rules with every removal logged, and charter-required documents that are missing flagged.

03

The committee adjudicates

Endpoint classification is the CEC's decision, made blinded, under the charter. We never adjudicate, classify an event, or assess causality.

The boundary, in writing

An assembled packet, never an adjudicated endpoint.

We assemble, order, redact and cite the source documents the charter requires. We do not adjudicate the event, classify an endpoint, assess causality or relatedness, or make any determination the charter reserves to the committee. Blinded adjudication is the committee's function and stays there.

Every redaction is logged with the rule that required it, so the sponsor's quality function can verify that blinding was applied consistently rather than taking it on trust.

Audit trail · Case #IME-4812 exportable
08:12Packet received · 342 pp / 2 packetssystem
08:3111 pages deduplicatedsystem
08:44p.140 flagged — wrong patientsystem
08:54Event packet complete · packet complete · redactions logged · cited 100%system
09:20Event packet reviewed · citations verifiedreviewer
09:26Event packet exported · adjudication recorded off-platformreviewer
Every access logged · file deleted 30 days after delivery
Why Medrecords AI

The rules the platform never breaks.

Medrecords AI EVERY LINE CITED
CASE #IME-4812 · ADAMS, T.342 pp
2/14 — ER visit, right knee p.4
4/18 — arthroscopic surgery p.61
p.140 — wrong patient quarantined
Medrecords AI
Read every page · cite every line

HIPAA, under a signed BAA

Every file is handled under our Business Associate Agreement, from the first byte.

Never trains a model

Your records are never used to train any AI model — ours or anyone else's.

Every line cited

If we can't cite it, we don't say it. Every sentence links to its source page.

Deleted after delivery

Files are deleted 30 days after delivery, with a full audit log of every access.

Powered by the platform

4 capabilities behind every event packet.

The event packet is 1 deliverable of the same platform that reads, sorts, and cites the whole record.

Medical Records OCR

Every source document read in full — hospital records, ECG tracings, laboratory reports, handwritten site notes — nothing skipped, nothing guessed.

IN ACTION · 342 pp / 2 packets → 27 documents, read in full

Medical Chronology

The event builds itself into a chronology, so the committee reads a sequence rather than a stack of undated documents.

IN ACTION · first symptom → event → outcome, 1 continuous timeline

Verifiable AI Citations

If we can't cite it, we don't say it. Every element of the packet links to the source document page it came from.

IN ACTION · every packet element → cited 100%

Medical Summary Reports

The packet formats straight into the adjudication system — your template, your charter's structure.

IN ACTION · event packet → committee-ready dossier
FAQ

Endpoint adjudication packets, answered.

No. Endpoint classification is the Clinical Endpoint Committee's blinded decision under the charter. We assemble, order, redact and cite the source documents the charter requires, so the committee adjudicates from a complete packet rather than a partial one.

Redactions are applied per the charter's own rules and every removal is logged with the rule that required it. That log lets the sponsor's quality function verify blinding was applied consistently, instead of accepting it on assurance.

It's flagged in the packet rather than quietly omitted. A committee adjudicating without knowing a required source is absent is a data quality problem that surfaces later, usually at the worst time.

No. Medrecords AI does not retrieve records from providers or facilities. You bring the records you already have — review starts in minutes from upload. Retrieval vendors take days; you can keep yours and still cut the review to minutes.

Send 1 file. We'll tell you what we can read.

No obligation. If the case type is buildable we'll scope it; if it isn't, we'll say so.