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gateClinicalTrials — Protocol, GxP & Trial Integrity Gate
// IMMO.QUICK · GATECLINICALTRIALS · ICH E6(R3) · CTR · 21 CFR PART 11

A safety report is never blocked.

gateClinicalTrials documents consent, protocol adherence, and adverse event reporting in clinical trials, anchored in ICH E6(R3), the EU Clinical Trials Regulation, and 21 CFR Part 11. Support for sponsors and CROs, never a replacement for them.

Request Access → See the architecture
In one sentence: gateClinicalTrials documents three aspects of a trial event, consent, protocol adherence, adverse event reporting, and seals the result, without ever controlling or blocking a real clinical action.
✓ RELEVANT IF...
  • You are sponsors, CROs, or trial sites that need to make consent documentation forensically provable
  • You want to document protocol deviations, not conceal them
  • You need an audit trail for adverse events that never jeopardises the report itself
× NOT RELEVANT IF...
  • You expect a system to obtain consent, administer a dose, or file a report itself
  • No connection point to an existing EDC or eTMF system exists
// The problem

A pure hash-chain documentation gate.

gateClinicalTrials does not intervene in day-to-day hospital processes. The connection point is the trial's existing EDC or eTMF system, with periodic pull, no direct access. The gate does not control consent collection, dosing, or reporting, it documents the hash trail the trial system already produces.

// Architecture

Three gates. One always runs.

Gate B only runs if Gate A passes. Gate C always runs, independent of the other two, that is by design, not an exception.

GATE A
Consent Documentation
Checks only the trial-pool validity of consent hashes, never a real consent action
GATE B
Protocol Adherence
Documents a window deviation, does not reject it, the administration already happened
GATE C
Adverse Event Reporting
Always runs, regardless of deadline overrun, never blocking
The one mandatory design rule
No verdict may discard or block a report of an adverse event, regardless of a deadline overrun. A late report is documented less favourably than a timely one, but it is still better captured than none at all. This rule is carried as a verified fact in the ledger, not just as a comment in the code.
// Bi-temporal rule selection

ICH E6(R2) versus ICH E6(R3), depending on submission time.

ICH E6(R2) applied until 23 July 2025, after which ICH E6(R3) applies. The gate applies to a receipt exactly the version that was valid at the T=0 submission time, not the version current at read time. An old receipt therefore permanently retains the rule that applied at the moment it was created.

Merkle-Kette: jedes versiegelte Studien-Ereignis-Receipt wird zum Vorgänger-Hash des nächsten

Per-tenant Merkle chain, every trial event extends it by one link

// Examples

Two fully fictional example decisions.

All trials, sites, and values on this page are invented and serve only to illustrate the gate logic.

Fully documented trial event
gateClinicalTrials · Gate A–C
A fictional trial site submits an event with complete consent documentation, protocol-compliant administration, and a timely reported observation.
consent_hashes_validtrue
protocol_deviationnone
ae_reported_within_deadlinetrue
TRIAL_EVENT_DOCUMENTED
Sealed. All three gates pass, the receipt status is fully sealed.
Late AE report, still fully captured
gateClinicalTrials · Gate C
Consent documentation is complete, but a report of an adverse event arrives twelve hours after the reporting deadline.
ae_reported_within_deadlinefalse
delta_hours_exceeded12.00
passedtrue
AE_REPORTED_LATE
Not blocked, ever. The report remains fully captured, the delay is documented, the report itself is never discarded.
// Clarification

What gateClinicalTrials is not.

  • Not an intervention in real clinical actions. The gate documents a hash trail, it does not obtain consent, administer a dose, or file a report itself.
  • Not an assessment of the medical correctness of a dose. Gate B only assesses whether the documented timing fell within the protocol window.
  • No certification by an ethics committee or regulatory authority. gateClinicalTrials claims no official endorsement.
  • No final rule coverage for non-traditional trial designs. ICH E6(R3) Annex 2 was not finally published as of the time of research, this gap is openly disclosed.

For sponsors and CROs that want to make their trial integrity provable.

gateClinicalTrials is open for conversation with sponsors, CROs, and trial sites who want to understand how deterministic governance infrastructure translates to ICH E6(R3).

Request Access → access@immoquick.eu
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