Abstract visualisation of a clinical trial visit matrix, with scattered deviation markers and one clustered signal highlighted for review

Aurelyn AI Clinical Academy

Every deviation
is a question.

Compliance-first, role-proportionate training for clinical research professionals using governed AI to detect, assess, escalate, correct, prevent and learn from protocol deviations — without ever delegating a determination to a machine.

12 modules · 72 lessons 18–22 hrs guided learning Capstone & certificate pathway WCAG 2.2 AA aligned
View curriculum

Signature programme

Built for the deviation work you actually do.

Written for clinical operations, site staff, monitoring, quality, data, biostatistics, safety and regulatory roles — not for technologists.

Deviation signal matrix with a highlighted cluster under review

Advanced · Enterprise professional development

AI for Protocol Deviation Management

A deviation is a moment when what happened to a participant differed from what the protocol promised. Most are small. A few decide whether a trial can be believed. This course teaches you to tell them apart quickly, consistently and defensibly, using AI as an instrument inside a governed system — and it is explicit throughout about where the machine stops and a named human begins.

Format
Interactive
Duration
18–22 hrs
Standard
80% mastery
Pathways
7 roles

The organising idea

Six verbs, in order, every time.

The workflow is the syllabus. Each module sits on one stage, so you always know which part of the job you are learning.

DetectModules 4–5

Rules, statistical signals and language-based review — and honest measurement of what you missed.

AssessModule 6

Three questions, three owners: safety, interpretability and analysis population.

EscalateModule 7

Observable triggers, awareness clocks and a jurisdiction matrix that records its negatives.

CorrectModule 8

Root cause that survives replacing every person, and CAPAs with falsifiable effectiveness checks.

PreventModule 9

Critical-to-quality design and the protocol patterns that manufacture deviations.

LearnModule 10

Denominators, thresholds and interpretation rules that stop dashboards causing confident errors.

Curriculum

Twelve modules. Seventy-two lessons.

Every module follows the same six-lesson rhythm, so you always know where you are. Select any module to begin there.

Role pathways

The same event, seven different questions.

Deviation management is a relay. Knowing which question is yours is most of the skill.

Site staff

Did what happened to this participant differ from the protocol, and who needs to know today?

Principal investigator

Was anyone put at risk, and can I still defend the integrity of this participant's data?

CRA / monitor

Is this isolated, or the visible edge of a pattern at this site?

Clinical operations

Where is this study losing control, and what changes if I intervene now?

Quality assurance

Does the corrective action reach the actual cause, and will it hold?

Data & biostatistics

Can this be coded, trended and reflected in the analysis population?

Medical monitor

Does this change the benefit-risk picture for this participant or this trial?

Assessment & credential

Twelve labs, a capstone, and a certificate you can defend.

Six triage laboratories and six branching decision simulations — several containing critical-failure paths you should hit here rather than at work. A nine-deliverable capstone on a multinational, multi-failure scenario with a weighted rubric. A thirty-six item final assessment drawn fresh each attempt, reported by domain. Your progress saves automatically and resumes wherever you left off.