eCOA domain model

Product boundary

eCOA owns the configured administration and completion of patient-, clinician-, and observer-reported outcome assessments. It does not own participant enrollment, the protocol endpoint, or the downstream statistical interpretation.

Instrument
└── InstrumentVersion
    ├── LicensedContent
    ├── TranslationVersion
    ├── ScoringDefinition
    └── ValidationEvidence

StudyAssessmentDesign
├── InstrumentPlacement
├── AssessmentSchedule
├── ReminderPolicy
└── Device/BYOD Policy
     └── ParticipantAssessment
         ├── AssessmentAdministration
         ├── ResponseSet
         ├── CompletionDecision
         └── DataChangeDecision

Key rules

• Instrument content, translation, scoring and license versions are independently traceable.
• An Assessment Instance identifies instrument version, respondent role, schedule occurrence and time window.
• Responses autosaved during administration are not final until the completion decision.
• Patient, clinician and observer respondents are explicit; one cannot substitute for another silently.
• Missed, partially completed, late and completed assessments are distinct outcomes used for adherence.
• Mid-study change identifies which future assessments adopt the new version and preserves prior completions.
• Device assignment is operational context, not part of the clinical response identity.

Evidence crosswalk

Observed product behaviour	TechSol decision	Difference / question
Central library holds reusable validated instruments	instrument, version, translation, license and validation evidence are separate	which components may a sponsor modify without revalidation?
Patients, clinicians and caregivers complete assessments	respondent role is intrinsic to each assessment occurrence	how is assisted completion represented without misattributing the respondent?
Mid-study changes retain audit/version control	adoption plan assigns future instances to a new design/version	can an incomplete active assessment migrate?