Five required result elements
Participant flow, baseline characteristics, outcome measures, adverse events, and protocol/summary results — all present and mapped to the registry data dictionary, or the pack does not release.
The most rigorous disclosure compliance pack a sponsor can submit.
Clinical Trial Results Disclosure & Registry Compliance Engine assembles a documentation-complete disclosure pack — every required field, every cross-registry mapping, the validation-error resolution log, and the audit-ready file — checked against the letter of 42 CFR Part 11 and FDA guidance before a specialist releases it.
Every applicable deadline of 42 CFR §11Five statutory submission elements, gate-checkedClinicalTrials.gov · EU CTIS · UMIN · ChiCTR cross-registry mappingSpecialist release on every pack5-business-day SLA
Why submissions fail
A single missing field can trigger a Notice of Noncompliance.
A sponsor's clinical trial disclosure is only as strong as the submission behind it. Miss one of the five required result elements, skip a required cross-registry mapping, mis-time the 12-month window, or fail to resolve a validation error — and the submission can be rejected, flagged, or expose the sponsor to civil money penalties.
Most sponsors run this by hand, from memory, once or twice a year. The regulation has not been read end-to-end since the last time it mattered. That is exactly where compliance gaps hide.
Clinical Trial Results Disclosure & Registry Compliance Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
23%
of applicable trials post results within 12 months of primary completion
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 42 CFR Part 11 and FDA guidance. These are the provisions each pack is held to.
12-month submission window
The submission date is verified to fall no later than 12 months after the primary completion date, computed deterministically — never estimated.
Every required registration field
Sponsor, responsible party, intervention, study type, eligibility, locations, and outcomes — established by protocol extraction, not assumption.
Cross-registry consistency
For trials also registered in EU CTIS, UMIN, or ChiCTR, a consistency check is performed and discrepancies are flagged for resolution.
Validation error resolution
A log of all registry validation errors and their resolution is included, with evidence that each error was addressed before resubmission.
Audit-ready file
The complete submission history, including all versions, correspondence, and the final accepted record, is compiled into an audit-ready package.
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A human specialist signs every release. That order is never reversed.
01
Compliance Gap Scan
Upload the protocol, SAP, CSR, and existing registry records. We return a free compliance read: which required elements and deadlines you already meet, and which are missing.
02
Evidence & cross-registry mapping
As your authorized clerical agent, we extract data from source documents and map fields to ClinicalTrials.gov, EU CTIS, and other registries, building a cross-registry consistency matrix.
03
Grounded drafting
The five required result elements are drafted from your validated data and the 42 CFR §11 rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
All required fields are populated; the 12-month window is verified; the cross-registry consistency check is resolved; validation errors are cleared. Any failure blocks release.
05
Specialist release
A disclosure specialist reviews the exception queue and signs the release. High-value or multi-registry trials route to attorney review first.
06
Delivery
You receive the pack: submission-ready XML, cross-registry mapping log, validation error resolution log, audit-ready file, and the compliance calendar — ready for the sponsor to submit under its own name.
The bar we hold
Rigor you can measure.
100%
Specialist-released
No pack ships without a human signature.
5 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
4
Cross-registry sources
ClinicalTrials.gov · EU CTIS · UMIN · ChiCTR, every applicable trial.
Why Clinical Trial Results Disclosure & Registry Compliance Engine
Built to be the most thorough option a sponsor has.
Documentation-complete, by design
The deliverable is completeness itself — every required field and cross-registry mapping accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run cross-registry checks as your clerical agent. We never give legal advice, certify compliance, or submit on your behalf without your approval.
Engagement
Flat fee, per released pack. No contingency, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any grant or funding.
- A free Compliance Gap Scan before you commit — see exactly what is missing.
- One flat fee per released Disclosure Compliance Pack; disclosed pass-through cross-registry mapping fees.
- Optional fixed-fee attorney review for high-value or multi-registry trials.
- Optional Backlog Remediation Add-on for overdue records, pre-dated to your compliance calendar.
FAQ
Questions, answered precisely.
Is Clinical Trial Results Disclosure & Registry Compliance Engine a law firm?
No. Clinical Trial Results Disclosure & Registry Compliance Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for high-value or multi-registry trials.
Do you submit the results on my behalf?
No. We prepare the submission-ready pack and provide it to you for review and submission. You remain the responsible party and submit under your own name. We can assist as a clerical agent if authorized.
What makes a pack 'complete'?
Completeness is defined by the regulation: the five 42 CFR §11.48(a) result elements present, the 12-month window verified, all required registration fields populated, cross-registry consistency checked, and validation errors resolved. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a specialist-released pack. The free Compliance Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through cross-registry mapping costs. No contingency and no percentage of any grant or funding.
See what's missing before it triggers a noncompliance letter.
Start with a free Compliance Gap Scan. Send your protocol, SAP, CSR, and existing registry records and we'll return a compliance read against every subsection of 42 CFR Part 11.
Documentation-completeness service · not legal advice · the sponsor submits every record.