Table 3.

The role of pathologists during different phases of an AIP project.

Project phase	Pathologist role
Feasibility	•Operate as key opinion leader (KOL) •Define product utility and requirements •Provide input on product or study design •Determine data availability and quality •Generate labeled data and ground truth •Address ethics and potential conflicts •Contribute to potential business use case
Verification	•Investigator role in sponsored research •Institutional review board approval •Manage material and data exchange •Assist with study design and expectancies •Assemble research use only (RUO) material •Substantiation of product performance •Sharing outcome results (e.g. publication) •Commercialization via technology transfer •Full disclosure regarding conflict of interest
Validation	•Investigator role during a clinical trial •Institutional review board approval •Corroborate product performance for intended use •Report validation and/or trial results (e.g. publication) •Assist with pre-market regulatory approval •Commercialization via technology transfer •Full disclosure regarding conflict of interest