ICH M15 MIDD Planning

From a scientific question of interest, use this skill to get guidance and generate ICHM15 documentation related to the planning phase of an MIDD project, as described in the final ICHM15 recommendations (ICHM15 step 5, June 2026).

See references/terms.md for the shared terminology used by the ICH M15 review skills.

When to use this skill

Use this skill when the user wants guidance that frames the assessment correctly, includes all required elements with ratings and justifications, and exposes missing evidence clearly.

Use it for:

• Question of Interest and Context of Use framing (§2.1.1–2.1.2)
• Model Influence, Consequence of Wrong Decision, Model Risk, and Model Impact (§2.1.3–2.1.6)
• Technical Criteria and Appropriateness of Proposed MIDD (§2.2.1–2.2.2, planning stage)
• Recommendation of a Model Analysis Planning (MAP) document

Note that this skill focuses specifically on the planning stage: drug developers are planning MIDD activities, before model outcomes are available. Required: all six key assessment elements + Technical Criteria + Appropriateness of Proposed MIDD. It leaves out the submission stage.