Find out where your sites will stumble on your study, before the first participant

What it is

Site teams usually meet a study's hardest decisions for real: an eligibility edge case, a consent question, a safety report clock. When a team gets one wrong, you often learn about it at the first monitoring visit.

We build short, realistic decision scenarios from your study's public registry record. Staff at your participating sites work through them online. Every decision is scored against CRLN-TRG-001, an open competency standard aligned to ICH E6(R3). You see which decisions site teams struggle with, by role, while it is still cheap to clarify.

We work only from what your study has already made public: the ClinicalTrials.gov record and anything you have published yourself. No confidential protocol is needed, and nothing confidential changes hands.

How it works

• We build 4 to 6 short scenarios from the public record: the registered eligibility criteria, arms and interventions, visit schedule and outcome timing, and the Good Clinical Practice decisions any site on the study will face, such as consent, safety reporting windows and deviations.
• You review and approve the scenario set before any site sees it.
• Staff at up to 5 of the sites you have already selected, up to 40 people, work through the scenarios online during a two week window.
• You receive a report by role, across sites, about five business days after the window closes. Groups of fewer than five people are never reported, so no individual can be identified.

Timing: about two weeks to build the scenarios, a two week window for sites, and the report five business days later.

What you receive

• A scenario set you review and approve before any site sees it
• A cross-site report: which decisions teams got wrong, how often, and by role
• Readiness by role for each site, reported only for groups of five or more people
• Which wrong answers were given with high confidence, which is where a clarification before activation does the most good
• Suggested clarifications for site initiation, tied to the registry field each decision was built from
• A clear list of what the public record could not test, so you know what a full protocol rehearsal would add

From a sample report

Illustrative sample. The study, sites and numbers below are fictional, made up to show the format of a report. They are not results from any real study, site or person.

Decisions most often missed (fictional example)

• Washout from prior chemotherapy before first dose (eligibility, exclusion criterion 4). Role: Coordinator. Missed: 9 of 14.
• Which prior therapies count toward the line of therapy limit (eligibility, inclusion criterion 3). Role: Investigator. Missed: 5 of 8.

What the sample suggests before activation: a one line clarification in the site initiation slides, and a date field on the eligibility checklist.

What the public record cannot test

Some decisions depend on details that live only in the locked protocol. The report lists them plainly rather than guessing:

• Exact dose modification tables and lab cutoffs not listed in the registry record
• Detailed visit windows and the schedule of assessments
• Investigational product handling from the pharmacy manual
• Sponsor specific reporting forms and timelines beyond the regulatory minimum

Those are what the full rehearsal on your locked protocol, the Protocol Readiness Pilot, adds. When your protocol is locked, the work from the check carries over into it.

Sites and staff never pay

The sponsor or CRO commissions the check. Research sites and their staff pay nothing, ever. It runs on the sites you have already selected and does not depend on other sponsors' data.

What is true today

• A working protocol module built from a publicly registered Phase 3 protocol, with every fact cited to the page. An independent site expert judged 18 of its 19 decision steps faithful to the protocol.
• An open standard, CRLN-TRG-001, published under CC BY 4.0 with a DOI and free for anyone to use.
• We do not promise fewer deviations. We measure, and a null result is a valid result.

What we never do

• Touch patient or participant data of any kind. No patient or participant data is used at any step.
• Recruit, match or refer patients.
• Share a named person's results except through their site, or with their agreement.

Request a free preview for your study

Give us your study's NCT number. We build a short preview from its public ClinicalTrials.gov record and send it to you by email.