An example of clinical trial operations as a governed process: agents do the 6 steps, and a person signs the gate before anything irreversible happens. Download it, import it into your workspace, and adapt it to your systems.
The graph6 agent steps1 human gatesigns: Principal investigator / medical monitor
Clinical-trial-ops autopilot
Trial operations — eligibility screening, source-data verification, reg-doc assembly — are slow, manual and Part 11 / GCP-validated, gating the cost and speed of every study. Patients are screened and matched, data abstracted and deviations flagged, and reg packages assembled straight-through; the PI / medical monitor signs eligibility and safety decisions.
The governed flow · branches, parallel work & a human on the irreversible step
screen-fail / ineligibleeligible / borderline candidateapproved to enrolldeviation / data query — rework
Start
agent · low risk
Ingest the protocol and pull candidate patient records from the EHR into the CTMS
parallel · fan-out / join
Run screening and reg-package prep concurrently
agent · low risk
Screen and match eligible patients against the protocol and abstract source data into the EDC
agent · low risk
Flag protocol deviations / data discrepancies and assemble the monitoring and regulatory package
parallel · fan-out / join
Join screening and reg-package prep
decision
Eligibility verdict?
agent · low risk
Clear screen-fail: log the ineligibility reason in the CTMS and close the candidate — a reversible, non-enrolling disposition
gate · human sign-off
The PI / medical monitor reviews eligibility, deviations and any safety determination and signs to enroll (or sends the case back for query resolution)signs: Principal investigator / medical monitor
decision
PI decision?
agent · high riskirreversible
Enroll the patient and submit the regulatory documents to the sponsor / IRB under Part 11
agent · low risk
Monitor safety signals, resolve EDC queries and maintain the eTMF
Done
low riskmedium riskhigh riskbranch / reworkgate · human sign-off
Use this example
01
Download the file
A minctrl.process/v1 document: the graph and the hash of the process it becomes.
02
Import it in Processes
Import into Minctrl opens this example in your workspace; one click stores it as your first version. Import JSON does the same with the file, and a file changed after download is refused.
03
Connect your systems
Every connector starts in shadow: steps run, nothing leaves Minctrl until you configure a connector and switch it live.
04
Adapt it
Change signers, time limits and steps on the canvas. Each save is a new version; a running case stays on the version it started with.
Questions
How do I automate clinical trial operations with Minctrl?+
Start from this example. Import the file in Processes, connect your own systems, and adapt the steps on the canvas. Agents run the reversible steps; every irreversible step waits at a gate for the role you choose. The example has 6 steps and 1 gate; you can change any of them.
Is clinical trial operations in Minctrl auditable?+
Every run start, signature and change to the process is written to a hash-chained audit log your auditor can verify and export. The example is modelled on GCP; whether your process meets it is a decision for your compliance team.
Does the AI decide everything?+
No. Minctrl will not make a process runnable while an irreversible step can be reached without a human gate, and one person cannot sign two gates of the same run.