Study Training domain model

Product boundary

Study Training determines who must learn what, by when, for which Study/Country/Site role or responsibility, and records completion evidence. Study responsibility is an input; it does not itself prove qualification.

TrainingMaterialVersion
└── TrainingRequirement
    └── StudyCurriculum
        ├── applicability: Study / Country / Site
        ├── LearnerRole criteria
        ├── Responsibility criteria
        └── TrainingAssignment
            ├── LearningAttempt
            ├── QuizAssessment
            └── TrainingCompletionEvidence

Key rules

• The training matrix resolves current Person participation, role, responsibility, location and curriculum version.
• Adding a Study Person can create assignments; ending participation cancels future applicability but retains history.
• A protocol or material revision runs an impact decision: no retraining, delta training, or full retraining.
• Completion applies to an exact training material/curriculum version and can produce a certificate for eTMF.
• Prior GCP credit may satisfy a requirement only through an explicit equivalence/acceptance decision.
• Qualification is derived from all effective requirements, not from one completion record.

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
Curricula can scope Study, Country, Site and Learner Role	applicability is a typed predicate over participation and responsibility	how are overlapping curricula de-duplicated?
Training matrix automation creates assignments	TrainingAssignmentPolicy explains every assignment and cancellation	must assignment creation be immediate or assessment-time derived?
Completion certificates can auto-file to eTMF	completion publishes evidence; eTMF independently accepts/classifies it	can external GCP evidence fulfill multiple sponsor requirements?