01
01
PARTICIPANT FLOW
PARTICIPANT FLOW
Milestone arithmetic that must reconcile across periods — structured rows, never prose.
Milestone arithmetic that must reconcile across periods — structured rows, never prose.
REGULATORY DISCLOSURE
One public record. Every milestone aligned.
One public record. Every milestone aligned.
One public record. Every milestone aligned.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
CLIENT AUTHORITY REMAINS EXPLICIT AT EVERY RELEASE POINT.
CLIENT AUTHORITY REMAINS EXPLICIT AT EVERY RELEASE POINT.
REGULATORY DISCLOSURE
One public record. Every milestone aligned.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
CLIENT AUTHORITY REMAINS EXPLICIT AT EVERY RELEASE POINT.
THE OPERATING PROBLEM
Can you do this yourself? Yes.
Can you do this yourself? Yes.
Can you do this yourself? Yes.
Can you do this yourself? Yes.
There is no licence we hold that you don’t. ClinicalTrials.gov is free, the review criteria are published, and registration, honestly, most teams can handle. Results is where it turns — the six places below defeat most first attempts, each failed cycle opens a correction window measured in days, and the unfinished record is already public. What we sell is not access. It is doing it once, cleanly, with a record you can defend without us in the room.
There is no licence we hold that you don’t. ClinicalTrials.gov is free, the review criteria are published, and registration, honestly, most teams can handle. Results is where it turns — the six places below defeat most first attempts, each failed cycle opens a correction window measured in days, and the unfinished record is already public. What we sell is not access. It is doing it once, cleanly, with a record you can defend without us in the room.
There is no licence we hold that you don’t. ClinicalTrials.gov is free, the review criteria are published, and registration, honestly, most teams can handle. Results is where it turns — the six places below defeat most first attempts, each failed cycle opens a correction window measured in days, and the unfinished record is already public. What we sell is not access. It is doing it once, cleanly, with a record you can defend without us in the room.
SIX PLACES FIRST ATTEMPTS FAIL
SIX PLACES FIRST ATTEMPTS FAIL
02
02
BASELINE CHARACTERISTICS
BASELINE CHARACTERISTICS
Counts that must tie to the participant flow, or carry a written explanation.
Counts that must tie to the participant flow, or carry a written explanation.
03
03
OUTCOME MEASURES
OUTCOME MEASURES
Every pre-specified measure, reported with its statistical analysis.
Every pre-specified measure, reported with its statistical analysis.
04
04
ADVERSE EVENTS
ADVERSE EVENTS
Three mandatory tables — mortality, serious events, and other events above threshold.
Three mandatory tables — mortality, serious events, and other events above threshold.
05
05
FREE-TEXT RULES
FREE-TEXT RULES
Results data written into a narrative field draws a standard major comment.
Results data written into a narrative field draws a standard major comment.
06
06
THE REVIEW LIST
THE REVIEW LIST
A published set of standard review comments that most first submissions meet.
A published set of standard review comments that most first submissions meet.
WORKFLOW
Submitted is not finished.
Submitted is not finished.
Submitted is not finished.
Submitted is not finished.
Follow one results submission through the system. The clock — and the record — are both statutory. Industry figures with their sources, not KARAMATA claims.
Follow one results submission through the system. The clock — and the record — are both statutory. Industry figures with their sources, not KARAMATA claims.
Follow one results submission through the system. The clock — and the record — are both statutory. Industry figures with their sources, not KARAMATA claims.
THE LIFE OF ONE SUBMISSION
THE LIFE OF ONE SUBMISSION
THE NUMBER
THE NUMBER
THE MOMENT
THE MOMENT
WHAT HAPPENS
WHAT HAPPENS
WHAT IT MEANS
WHAT IT MEANS
SOURCE
SOURCE
01
01
Day 0
Day 0
A results submission goes in
A results submission goes in
Quality-control review begins against the registry’s published criteria — and so does the calendar
Quality-control review begins against the registry’s published criteria — and so does the calendar
Everything that follows is on a statutory clock
Everything that follows is on a statutory clock
42 CFR Part 11
42 CFR Part 11
02
02
17%
17%
The first review returns
The first review returns
Fewer than one in five non-industry results submissions pass the first cycle; the rest receive major comments
Fewer than one in five non-industry results submissions pass the first cycle; the rest receive major comments
Most teams enter the comment cycle without having planned for it
Most teams enter the comment cycle without having planned for it
Zarin et al., NEJM 2019
Zarin et al., NEJM 2019
03
03
Day 30
Day 30
The record goes public
The record goes public
Results post publicly whether or not review has concluded — open comments post with them, and earlier versions stay in the public archive
Results post publicly whether or not review has concluded — open comments post with them, and earlier versions stay in the public archive
An unfinished record is not a private problem
An unfinished record is not a private problem
NLM posting procedures
NLM posting procedures
04
04
25 days
25 days
The correction window
The correction window
Each round of results comments opens a 25-calendar-day window, counted from the electronic notification — not from when anyone reads it
Each round of results comments opens a 25-calendar-day window, counted from the electronic notification — not from when anyone reads it
The clock runs whether or not the email is opened
The clock runs whether or not the email is opened
42 CFR 11.64(b)
42 CFR 11.64(b)
05
05
116 → 39
116 → 39
What discipline changes
What discipline changes
Days in review at one academic centre, after submissions were checked against the registry’s own criteria before going in — first-pass rate nearly quadrupled
Days in review at one academic centre, after submissions were checked against the registry’s own criteria before going in — first-pass rate nearly quadrupled
First-pass quality is a method, not luck
First-pass quality is a method, not luck
Tetteh et al., Clinical Trials 2020
Tetteh et al., Clinical Trials 2020
WHEN TO ENGAGE
On time for FDA. Too late for the journal.
On time for FDA. Too late for the journal.
On time for FDA. Too late for the journal.
On time for FDA. Too late for the journal.
Register after the first consent but inside FDA’s 21 days and you have met the law — and the top journals can still refuse the paper, permanently. The registry shows both dates, and neither can be changed. You did the hard part; your patients showed up on the understanding that what was learned would see the light. Nothing should undo that over a date in a database — talk to us before your first patient.
Register after the first consent but inside FDA’s 21 days and you have met the law — and the top journals can still refuse the paper, permanently. The registry shows both dates, and neither can be changed. You did the hard part; your patients showed up on the understanding that what was learned would see the light. Nothing should undo that over a date in a database — talk to us before your first patient.
Register after the first consent but inside FDA’s 21 days and you have met the law — and the top journals can still refuse the paper, permanently. The registry shows both dates, and neither can be changed. You did the hard part; your patients showed up on the understanding that what was learned would see the light. Nothing should undo that over a date in a database — talk to us before your first patient.
TWO DEADLINES · THREE QUIET MISTAKES
TWO DEADLINES · THREE QUIET MISTAKES
01
01
Federal law: register within 21 days after first enrollment
Federal law: register within 21 days after first enrollment
Federal law: register within 21 days after first enrollment
02
02
The journals: registered before the first patient consents
The journals: registered before the first patient consents
The journals: registered before the first patient consents
03
03
An incomplete registration reads as unregistered
An incomplete registration reads as unregistered
An incomplete registration reads as unregistered
04
04
Ethics approval is not registration
Ethics approval is not registration
Ethics approval is not registration
05
05
A data-sharing plan left “Undecided” fails at the manuscript
A data-sharing plan left “Undecided” fails at the manuscript
A data-sharing plan left “Undecided” fails at the manuscript
FIVE DISCLOSURE DOMAINS
The disclosure clock runs the length of your trial.
The disclosure clock runs the length of your trial.
The disclosure clock runs the length of your trial.
The disclosure clock runs the length of your trial.
ONE TRIAL/FIVE MOMENTS THE CLOCK MOVES — AND WHERE WE CARRY IT
THE DISCLOSURE TIMELINE
THE DISCLOSURE TIMELINE
STAGE
STAGE
THE DEADLINE
THE DEADLINE
OUR WORK
OUR WORK
YOU RETAIN
YOU RETAIN
01
01
Before first enrollment
Before first enrollment
Registration is due 21 days after the first participant enrolls — and journals require it before the first consent. Registered late is permanent.
Registration is due 21 days after the first participant enrolls — and journals require it before the first consent. Registered late is permanent.
The full registration record, mapped field by field — including the items journals check — and staged for your release.
The full registration record, mapped field by field — including the items journals check — and staged for your release.
You review and release. Applicability remains with your regulatory function.
You review and release. Applicability remains with your regulatory function.
02
02
While the trial runs
While the trial runs
Status changes carry 30-day update windows, and every record requires an annual verification — even when nothing changed.
Status changes carry 30-day update windows, and every record requires an annual verification — even when nothing changed.
Record maintenance and the disclosure calendar — every date on every record, held as a system instead of a memory.
Record maintenance and the disclosure calendar — every date on every record, held as a system instead of a memory.
You approve each update before it goes in.
You approve each update before it goes in.
03
03
Primary completion
Primary completion
The results clock starts: one year, statutory.
The results clock starts: one year, statutory.
The four results modules, built from your protocol and SAP and checked against the registry’s own review criteria before anything is submitted.
The four results modules, built from your protocol and SAP and checked against the registry’s own review criteria before anything is submitted.
You approve the content; your Responsible Party releases and certifies.
You approve the content; your Responsible Party releases and certifies.
04
04
After submission
After submission
Review runs up to 30 days per cycle. Comments open a 15- or 25-day correction window, counted from the notification.
Review runs up to 30 days per cycle. Comments open a 15- or 25-day correction window, counted from the notification.
Every comment classified and resolved inside the window, through to a clean posted record — on records we prepared, and on records we inherit.
Every comment classified and resolved inside the window, through to a clean posted record — on records we prepared, and on records we inherit.
You release each resubmission — staged at day 10, not day 24.
You release each resubmission — staged at day 10, not day 24.
05
05
Joining mid-stream
Joining mid-stream
An inherited portfolio, a departed coordinator, records in unknown states.
An inherited portfolio, a departed coordinator, records in unknown states.
A hand-verified portfolio assessment from public data, and backlog remediation to a clean posted state.
A hand-verified portfolio assessment from public data, and backlog remediation to a clean posted state.
Every finding arrives with the reasons it may not apply to you.
Every finding arrives with the reasons it may not apply to you.
AUTHORITY BY DESIGN
Clear ownership. Defined boundaries.
Clear ownership. Defined boundaries.
Clear ownership. Defined boundaries.
Clear ownership. Defined boundaries.
We carry the record. You keep the decisions — and the release button, which where you are the Responsible Party is yours by design.
We carry the record. You keep the decisions — and the release button, which where you are the Responsible Party is yours by design.
We carry the record. You keep the decisions — and the release button, which where you are the Responsible Party is yours by design.
AUTHORITY MATRIX
AUTHORITY MATRIX
KARAMATA PREPARES
KARAMATA PREPARES
—
—
Record structure and field-by-field mapping
Record structure and field-by-field mapping
—
—
Entry in your organisation’s PRS account
Entry in your organisation’s PRS account
—
—
Quality review against the registry’s published criteria
Quality review against the registry’s published criteria
—
—
Comment responses, staged inside the window
Comment responses, staged inside the window
—
—
The documented preparation trail behind every entry
The documented preparation trail behind every entry
YOU DECIDE AND RELEASE
YOU DECIDE AND RELEASE
—
—
Applicability and legal judgment
Applicability and legal judgment
—
—
Approval of content and every update
Approval of content and every update
—
—
Release and certification of each submission
Release and certification of each submission
—
—
Public release
Public release
—
—
The decisions the regulation reserves to you
The decisions the regulation reserves to you
NEVER DETERMINED BY KARAMATA
NEVER DETERMINED BY KARAMATA
—
—
Whether a trial is an applicable clinical trial
Whether a trial is an applicable clinical trial
—
—
Eligibility for delayed certification
Eligibility for delayed certification
—
—
Responsible Party designation
Responsible Party designation
—
—
These remain with your regulatory function or counsel
These remain with your regulatory function or counsel
—
—
Stated in every scope of work
Stated in every scope of work
SYSTEM & SECURITY BOUNDARIES
You hold the IND. The record holds your name.
You hold the IND. The record holds your name.
You hold the IND. The record holds your name.
You hold the IND. The record holds your name.
WHAT THAT MEANS
WHAT THAT MEANS
01
01
THE DUTY IS PERSONAL
THE DUTY IS PERSONAL
Under the regulation, the IND holder is the sponsor — and the sponsor is the Responsible Party. Your institution can administer the account; it cannot carry the duty.
Under the regulation, the IND holder is the sponsor — and the sponsor is the Responsible Party. Your institution can administer the account; it cannot carry the duty.
02
02
THE RELEASE IS YOURS
THE RELEASE IS YOURS
Where you are the Responsible Party, only you can release — every submission, every correction. Your part takes minutes per cycle, and we tell you exactly when.
Where you are the Responsible Party, only you can release — every submission, every correction. Your part takes minutes per cycle, and we tell you exactly when.
03
03
THE PREPARATION IS OURS
THE PREPARATION IS OURS
We prepare everything inside your own account — named user, no shared credentials — with the trail you would need to defend the record without us in the room.
We prepare everything inside your own account — named user, no shared credentials — with the trail you would need to defend the record without us in the room.
FAQ
Questions we hear before the work begins.
Questions we hear before the work begins.
Questions we hear before the work begins.
Questions we hear before the work begins.
Straight answers, before a signature asks for them.
Straight answers, before a signature asks for them.
Straight answers, before a signature asks for them.
01
01
Doesn’t our institution handle ClinicalTrials.gov?
Doesn’t our institution handle ClinicalTrials.gov?
Doesn’t our institution handle ClinicalTrials.gov?
Institutions administer accounts and often do the data entry. The regulatory duty sits with the Responsible Party — for sponsor-held trials, the sponsor; for an investigator-held IND, the investigator personally. Who that is for your trial is worth establishing precisely, before a deadline does it for you.
Institutions administer accounts and often do the data entry. The regulatory duty sits with the Responsible Party — for sponsor-held trials, the sponsor; for an investigator-held IND, the investigator personally. Who that is for your trial is worth establishing precisely, before a deadline does it for you.
02
02
We published the paper. Isn’t that the results?
We published the paper. Isn’t that the results?
We published the paper. Isn’t that the results?
03
03
What happens if a record is late?
What happens if a record is late?
What happens if a record is late?
04
04
It’s a phase 1 study — does any of this apply?
It’s a phase 1 study — does any of this apply?
It’s a phase 1 study — does any of this apply?
05
05
How long does it take?
How long does it take?
How long does it take?
06
06
Can you work in our systems?
Can you work in our systems?
Can you work in our systems?
07
07
What remains when you’re done?
What remains when you’re done?
What remains when you’re done?
Bring us the record and the date on it.
Bring us the record and the date on it.
Bring us the record and the date on it.
Bring us the record and the date on it.
Tell us the study, what the registry shows today, and the deadline you’re looking at. We’ll look at it with you, say plainly what we see, and suggest a first step. The work is yours; the patients were real — our job is making sure the record does them justice. A real person replies within 24 hours — no sales desk, no deck.
Tell us the study, what the registry shows today, and the deadline you’re looking at. We’ll look at it with you, say plainly what we see, and suggest a first step. The work is yours; the patients were real — our job is making sure the record does them justice. A real person replies within 24 hours — no sales desk, no deck.
Tell us the study, what the registry shows today, and the deadline you’re looking at. We’ll look at it with you, say plainly what we see, and suggest a first step. The work is yours; the patients were real — our job is making sure the record does them justice. A real person replies within 24 hours — no sales desk, no deck.