Example processhealthcareGCP

Clinical trial operations automation software

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.

Download example · JSONImport into Minctrl →

minctrl.process/v1 · hash 11e738384c1d…ea1b

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.

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