Inclusion-Exclusion Criteria Builder

Reference Module Integration

The references/ directory is not optional background material. It defines the operational rules that must be actively used while running this skill.

Use the reference modules as follows:

• references/clarification-gating-rules.md → use before drafting long-form eligibility outputs and whenever user intent or population boundaries are underspecified.
• references/population-framing-rules.md → use when translating the user’s target population into an operational source population in Sections A and B.
• references/inclusion-criteria-rules.md → use when drafting inclusion rules in Sections C and F.
• references/exclusion-criteria-rules.md → use when drafting exclusion rules in Sections D and F.
• references/time-window-and-index-rules.md → use when defining timing anchors, baseline windows, prior-treatment windows, washout periods, and eligibility timing in Sections B, C, D, and E.
• references/field-operationalization-rules.md → use when tying criteria to chart fields, diagnosis codes, laboratory tests, pathology, imaging, medications, or procedures in Sections E and F.
• references/ambiguity-and-edge-case-rules.md → use when identifying vague wording, overlap, contradiction, or screening uncertainty in Sections G and H.
• references/output-section-guidance.md → use as the formatting and content control standard for Sections A–J.
• references/workflow-step-template.md → use to keep the reasoning sequence aligned with the required step order.

If any output section is generated without using its corresponding reference module, the output should be treated as incomplete.

Input Validation

Valid input: one or more of the following:

• a study topic, disease area, or target population needing inclusion/exclusion criteria
• a draft set of eligibility criteria needing refinement
• a retrospective or prospective screening plan needing operational rules
• an EHR or chart-review study requiring executable patient selection logic
• a protocol section requiring auditable, reproducible eligibility wording

Examples:

• "Build inclusion and exclusion criteria for a retrospective cohort of metastatic NSCLC patients receiving first-line immunotherapy."
• "Help me turn this target population into chart-review screening rules."
• "Our study is about sepsis patients in the ICU. Please create clear eligibility criteria with time windows."
• "Refine these draft criteria so they are executable and auditable."
• "I need inclusion and exclusion criteria for a biomarker study using archived tumor tissue."

Out-of-scope — respond with the redirect below and stop:

• requests for patient-specific medical eligibility decisions
• requests to screen actual patients from live records
• requests for direct treatment recommendations
• non-biomedical eligibility or recruitment tasks

"This skill is designed to build protocol-stage inclusion and exclusion criteria for biomedical research. Your request ([restatement]) is outside that scope because it requires [patient-specific eligibility judgment / live-record screening execution / treatment advice / non-biomedical support]."

Clarification-First Rule

This skill has a mandatory clarification gate.

If the user has not clearly specified enough of the following to define an executable target population, you must ask focused follow-up questions before producing a long eligibility framework:

• disease or condition
• study setting or data source
• study type or use case
• target treatment / exposure / procedure / specimen context, if relevant
• key time anchor or enrollment moment
• core population narrowing features (for example stage, severity, therapy line, age group, specimen availability, follow-up requirement)

When clarification is needed:

• ask concise, high-yield narrowing questions
• explicitly state that the current request is too broad or ambiguous for reliable eligibility drafting
• do not generate a long inclusion/exclusion section first and patch it later
• if necessary, offer a minimal provisional scaffold only after the questions, clearly labeled as provisional

This rule is mandatory. Broad, underspecified requests should trigger clarification rather than premature completion.

Sample Triggers

• "Generate inclusion and exclusion criteria for this study."
• "Make these eligibility criteria more executable."
• "Turn this target population into chart-review rules."
• "Help me reduce ambiguity in our screening criteria."
• "What should be inclusion vs exclusion in this cohort design?"
• "Please pressure-test these eligibility criteria for operational problems."

Core Function

This skill should:

1. restate the intended target population and likely study context
2. identify what information is still missing for executable eligibility drafting
3. ask clarifying questions first when boundaries are not yet specific enough
4. translate the target population into an operational source population and screening frame
5. define inclusion criteria with explicit, reviewable language
6. define exclusion criteria with explicit rationale and timing anchors
7. connect major criteria to chart fields, tests, procedures, medications, pathology, imaging, or specimen requirements when relevant
8. identify contradictory, redundant, unverifiable, or overrestrictive criteria
9. flag edge cases that require adjudication or reviewer instructions
10. produce an auditable eligibility framework that reduces screening ambiguity

This skill should not:

• produce long generic criteria when the population is still underspecified
• silently assume the disease stage, therapy line, setting, or time anchor if the user has not implied them clearly
• mix baseline eligibility with follow-up outcomes or post-enrollment events
• create exclusion rules that duplicate inclusion rules without adding control value
• recommend medically unrealistic or operationally unverifiable criteria without labeling them as such
• imply that the proposed criteria are final if key scope elements remain uncertain

Supported Study Contexts

This skill can be used for:

• retrospective or prospective cohort studies
• case-control studies
• real-world evidence studies using EHR, claims, registry, or chart-review data
• biomarker studies with tissue, blood, imaging, or assay requirements
• translational studies requiring linked clinical eligibility logic
• protocol drafting where eligibility needs to be clear, auditable, and reproducible

If the study context is not explicitly stated, infer the most likely context from the user’s description, but label any such inference as an assumption.

Decision Logic

Step 1 — Check whether clarification is mandatory

Use references/clarification-gating-rules.md to decide whether the request is specific enough for long-form eligibility drafting. If not, ask narrowing questions first.

Step 2 — Restate the intended population and screening frame

Use references/population-framing-rules.md to define the likely disease context, setting, index moment, and source population.

Step 3 — Define the core inclusion logic

Use references/inclusion-criteria-rules.md and references/time-window-and-index-rules.md to decide what must be true for a participant or record to qualify.

Step 4 — Define the core exclusion logic

Use references/exclusion-criteria-rules.md and references/time-window-and-index-rules.md to identify which factors should exclude a participant or record and why.

Step 5 — Operationalize major criteria

Use references/field-operationalization-rules.md to tie important criteria to concrete data fields, tests, dates, procedures, pathology, medications, or specimen evidence.

Step 6 — Pressure-test ambiguity and contradictions

Use references/ambiguity-and-edge-case-rules.md to identify criteria that are vague, redundant, contradictory, circular, or likely to be inconsistently applied.

Step 7 — Produce an auditable eligibility framework

Use references/output-section-guidance.md to produce a structured final output with executable criteria and reviewer-facing notes.

Mandatory Output Structure

When sufficient detail exists to draft the framework, always output the following sections.

A. Study Restatement and Eligibility Scope

Briefly restate the likely study type, target population, study setting, and any assumptions you had to make.

B. Operational Source Population and Screening Frame

Define where eligible records or participants would come from and what initial screening frame is implied.

C. Proposed Inclusion Criteria

Present the inclusion criteria in clear, numbered form.

D. Proposed Exclusion Criteria

Present the exclusion criteria in clear, numbered form.

E. Time Anchors, Windows, and Required Evidence

State the key eligibility timing logic, such as diagnosis window, treatment line, baseline period, test timing, washout period, specimen timing, or follow-up requirement.

F. Operationalization Table

Use a table with columns such as:

• criterion
• type (inclusion / exclusion)
• operational evidence source
• timing rule
• notes / ambiguity risk

This table is strongly recommended whenever the criteria must be mapped to chart review, EHR extraction, or auditable screening.

G. Ambiguity, Conflict, and Screening-Risk Review

Identify unclear wording, contradictory logic, hidden reviewer discretion, unverifiable requirements, and overrestriction risks.

H. Edge Cases Requiring Adjudication Rules

List the main scenarios where two reviewers might disagree and state how those cases should be handled.

I. Minimal Clarifications Still Needed

If any important scope elements remain uncertain, list the minimum additional questions required to finalize the criteria.

J. Final Eligibility Draft Status

Label the current draft as one of:

• provisional — major clarification still needed
• workable draft — usable with minor clarification
• operational draft — ready for protocol use and screening SOP refinement

Formatting Expectations

• Use concise biomedical protocol language.
• Prefer numbered criteria for inclusion and exclusion sections.
• Use tables when mapping criteria to operational evidence or ambiguity review.
• Explicitly label assumptions instead of hiding them.
• Distinguish what is executable now from what still needs clarification.
• If the request is underspecified, ask targeted questions before long output.
• Do not inflate the response with generic eligibility boilerplate.

Hard Rules

1. Clarification before completion when scope is underspecified. If disease context, target population, setting, or time anchor is too vague for executable criteria, ask narrowing questions first.
2. Do not silently invent population boundaries. Do not assume stage, severity, therapy line, prior treatment status, specimen availability, or follow-up requirements unless the user provided them or they are strongly implied.
3. Do not mix baseline eligibility with downstream outcomes. Post-enrollment events, response status, survival status, or future laboratory changes must not be used as baseline eligibility criteria unless the study design explicitly requires them for retrospective case definition and that choice is clearly labeled.
4. Every major criterion must be operationalizable. If a criterion cannot plausibly be verified from chart fields, registry variables, pathology, medications, imaging, procedures, or explicit screening questions, label it as weakly operationalized.
5. Avoid redundant duplication between inclusion and exclusion. Do not create exclusion criteria that merely restate the inverse of inclusion criteria unless doing so prevents a known screening ambiguity.
6. Do not overrestrict without protocol value. Exclusion rules should reduce confounding, improve validity, or protect interpretability—not merely make the cohort cleaner without justification.
7. State timing explicitly. Eligibility tied to diagnosis, treatment, testing, baseline, washout, prior therapy, or specimen collection must include a timing anchor whenever relevant.
8. Flag unverifiable or judgment-heavy criteria. Terms such as “clinically significant,” “adequate,” “recent,” “active,” or “severe” must be operationalized or labeled as ambiguous.
9. Do not fabricate field availability. Never claim that specific EHR fields, registry variables, ICD codes, pathology data, lab timestamps, or specimen metadata are available unless the user provided that information.
10. Do not fabricate literature, guidelines, PMIDs, DOIs, prevalence, or screening feasibility. If external justification is not provided, keep the logic protocol-based and assumption-labeled.
11. Include a self-critical risk review. State the most ambiguity-prone criterion, the most likely reviewer-disagreement point, the criterion most likely to shrink the cohort excessively, and the criterion most vulnerable to misclassification.
12. Make the output auditable. A different reviewer should be able to understand how each key criterion would be applied.

Interactive Refinement Rule

If the user provides draft criteria, do not simply rewrite them. First identify:

• what is already strong
• what is ambiguous or contradictory
• what cannot currently be operationalized
• what additional questions must be answered before finalization

Then revise the criteria in a way that preserves the study intent while improving executability.

What This Skill Should Not Do

This skill should not:

• decide whether a specific real patient is eligible for care or trial enrollment
• replace ethics review, regulatory review, or formal site feasibility review
• invent database fields, specimen availability, or code lists
• treat vague clinical adjectives as executable screening logic
• assume that narrower criteria are always better criteria

Quality Standard

A high-quality output from this skill should:

• convert scientific intent into executable and reviewable eligibility logic
• reduce screening ambiguity rather than create more of it
• clearly separate inclusion, exclusion, timing, and operational evidence
• surface edge cases before they become screening inconsistencies
• ask clarifying questions first when the request is too broad for reliable drafting
• be usable as a protocol draft input, chart review rule base, or screening SOP starting point