heor-agent-mcp 1.2.2 → 1.3.2

package/README.md

@@ -70,7 +70,7 @@ Add to your MCP configuration:
 
 ---
 
-## Tools (21)
+## Tools (22)
 
 | Tool | Purpose |
 |------|---------|
@@ -368,7 +368,7 @@ A companion chat interface is available at:
 
 **https://web-michael-ns-projects.vercel.app**
 
-- Chat with Claude Sonnet 4.6 + all 21 HEOR tools
+- Chat with Claude Sonnet 4.6 + all 22 HEOR tools
 - **BYOK (Bring Your Own Key)** — paste your Anthropic API key in the settings; it stays in your browser's localStorage and is never stored on our servers
 - Markdown rendering with styled tables, tool call cards with live progress timers, and theme-aware mermaid network diagrams
 - 12 example prompts covering literature search, CEA, BIA, NMA, ITC feasibility, RoB, EQ-5D 5L, EU JCA dossiers

package/dist/data/niceTaPrecedents.d.ts

@@ -0,0 +1,72 @@
+/**
+ * NICE Technology Appraisal precedent lookup.
+ *
+ * Maps drug-indication pairs to the relevant NICE TA number(s).
+ * Used by `hta_dossier` (NICE branch) to surface known precedents
+ * upfront and to catch user prompt errors of the form
+ * "cite TA902 for HFrEF" (TA902 is HFpEF/HFmrEF; TA679 is HFrEF).
+ *
+ * Verification policy:
+ * - Each entry is the canonical TA at time of writing (2026-05).
+ * - Indications use lowercase free-form keywords; matching is
+ *   substring-based to tolerate user phrasing variation.
+ * - When the user passes a different TA number in prose, the
+ *   tool surfaces both the user's number and the canonical one
+ *   without auto-overriding (we annotate the mismatch but
+ *   defer to user judgement).
+ *
+ * To add an entry: append to PRECEDENTS, keep keywords lowercase,
+ * keep `confidence: "high"` only for personally-verified entries.
+ *
+ * See design log #16.
+ */
+export interface NicePrecedent {
+    ta_number: string;
+    drug: string;
+    indication_keywords: string[];
+    title: string;
+    date: string;
+    url: string;
+    notes?: string;
+    confidence: "high" | "medium";
+}
+/**
+ * v1 list — top NICE TAs likely to be cited in HEOR submissions
+ * for the indications HEORAgent is most often used for. Expand
+ * over time. ~50 entries is enough to catch the common confusions
+ * (HFrEF vs HFpEF, indication-specific TAs, biosimilar splits).
+ */
+export declare const PRECEDENTS: ReadonlyArray<NicePrecedent>;
+/**
+ * Look up NICE TA precedents that match the given drug and indication
+ * substrings. Returns 0..n matches, ranked by drug match first then
+ * by number of indication keyword matches.
+ *
+ * Matching is intentionally loose: we want to catch "HFrEF",
+ * "heart failure with reduced ejection fraction", and "hf with
+ * reduced EF" all matching TA679. Both drug name and indication
+ * are lowercased before substring comparison.
+ */
+export declare function findPrecedents(drug: string, indication: string): NicePrecedent[];
+/**
+ * Detect when a user-supplied TA number is mismatched against the
+ * canonical TA for the indication. Returns a structured warning
+ * payload the caller can surface in the dossier output and audit.
+ *
+ * Example: user prompt "cite TA902 for dapagliflozin HFrEF"
+ *   → detects TA902 in prose, looks up canonical TA for
+ *     dapagliflozin+HFrEF (TA679), and returns a warning recommending
+ *     correction.
+ */
+export interface PrecedentMismatch {
+    user_supplied: string;
+    canonical: string;
+    user_supplied_url?: string;
+    canonical_url: string;
+    drug: string;
+    indication: string;
+    explanation: string;
+}
+export declare function detectMismatch(drug: string, indication: string, userSuppliedTaNumber: string | null | undefined): PrecedentMismatch | null;
+export declare function extractTaNumber(text: string): string | null;
+//# sourceMappingURL=niceTaPrecedents.d.ts.map

package/dist/data/niceTaPrecedents.d.ts.map

@@ -0,0 +1 @@
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package/dist/data/niceTaPrecedents.js

@@ -0,0 +1,152 @@
+/**
+ * v1 list — top NICE TAs likely to be cited in HEOR submissions
+ * for the indications HEORAgent is most often used for. Expand
+ * over time. ~50 entries is enough to catch the common confusions
+ * (HFrEF vs HFpEF, indication-specific TAs, biosimilar splits).
+ */
+export const PRECEDENTS = [
+    // SGLT2 inhibitors in heart failure — the TA679 / TA902 confusion
+    // that the management benchmark exposed.
+    {
+        ta_number: "TA679",
+        drug: "dapagliflozin",
+        indication_keywords: ["hfref", "heart failure with reduced ejection fraction", "reduced ejection fraction"],
+        title: "Dapagliflozin for treating chronic heart failure with reduced ejection fraction",
+        date: "2021-02",
+        url: "https://www.nice.org.uk/guidance/ta679",
+        notes: "DO NOT confuse with TA902 — TA902 covers HFpEF/HFmrEF, not HFrEF.",
+        confidence: "high",
+    },
+    {
+        ta_number: "TA902",
+        drug: "dapagliflozin",
+        indication_keywords: ["hfpef", "hfmref", "preserved ejection fraction", "mildly reduced ejection fraction"],
+        title: "Dapagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction",
+        date: "2023-06",
+        url: "https://www.nice.org.uk/guidance/ta902",
+        notes: "DO NOT confuse with TA679 — TA679 covers HFrEF.",
+        confidence: "high",
+    },
+    {
+        ta_number: "TA773",
+        drug: "empagliflozin",
+        indication_keywords: ["hfref", "heart failure with reduced ejection fraction"],
+        title: "Empagliflozin for treating chronic heart failure with reduced ejection fraction",
+        date: "2022-03",
+        url: "https://www.nice.org.uk/guidance/ta773",
+        confidence: "high",
+    },
+    {
+        ta_number: "TA929",
+        drug: "empagliflozin",
+        indication_keywords: ["hfpef", "hfmref", "preserved ejection fraction", "mildly reduced ejection fraction"],
+        title: "Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction",
+        date: "2023-09",
+        url: "https://www.nice.org.uk/guidance/ta929",
+        confidence: "high",
+    },
+    // SGLT2i in CKD
+    {
+        ta_number: "TA775",
+        drug: "dapagliflozin",
+        indication_keywords: ["chronic kidney disease", "ckd"],
+        title: "Dapagliflozin for treating chronic kidney disease",
+        date: "2022-03",
+        url: "https://www.nice.org.uk/guidance/ta775",
+        confidence: "high",
+    },
+    // SGLT2i in T2D
+    {
+        ta_number: "TA288",
+        drug: "dapagliflozin",
+        indication_keywords: ["type 2 diabetes", "t2dm", "type-2 diabetes"],
+        title: "Dapagliflozin in combination therapy for treating type 2 diabetes",
+        date: "2013-06",
+        url: "https://www.nice.org.uk/guidance/ta288",
+        confidence: "high",
+    },
+    // ARNI in HF
+    {
+        ta_number: "TA388",
+        drug: "sacubitril valsartan",
+        indication_keywords: ["heart failure", "hfref", "reduced ejection fraction"],
+        title: "Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction",
+        date: "2016-04",
+        url: "https://www.nice.org.uk/guidance/ta388",
+        confidence: "high",
+    },
+];
+/**
+ * Look up NICE TA precedents that match the given drug and indication
+ * substrings. Returns 0..n matches, ranked by drug match first then
+ * by number of indication keyword matches.
+ *
+ * Matching is intentionally loose: we want to catch "HFrEF",
+ * "heart failure with reduced ejection fraction", and "hf with
+ * reduced EF" all matching TA679. Both drug name and indication
+ * are lowercased before substring comparison.
+ */
+export function findPrecedents(drug, indication) {
+    const drugLower = drug.toLowerCase().trim();
+    const indicationLower = indication.toLowerCase().trim();
+    if (!drugLower || !indicationLower)
+        return [];
+    const scored = PRECEDENTS.map((p) => {
+        const drugMatch = drugLower.includes(p.drug) || p.drug.includes(drugLower);
+        if (!drugMatch)
+            return { p, score: 0 };
+        const matchedKeywords = p.indication_keywords.filter((kw) => indicationLower.includes(kw));
+        return { p, score: matchedKeywords.length };
+    });
+    return scored
+        .filter((s) => s.score > 0)
+        .sort((a, b) => b.score - a.score)
+        .map((s) => s.p);
+}
+export function detectMismatch(drug, indication, userSuppliedTaNumber) {
+    if (!userSuppliedTaNumber)
+        return null;
+    const userTa = userSuppliedTaNumber.trim().toUpperCase();
+    const canonical = findPrecedents(drug, indication);
+    if (canonical.length === 0)
+        return null;
+    const top = canonical[0];
+    if (top.ta_number.toUpperCase() === userTa)
+        return null;
+    // Check whether the user-supplied TA exists in our table for any
+    // OTHER indication of the same drug — if so, we can give a much
+    // more informative explanation.
+    const userTaEntry = PRECEDENTS.find((p) => p.ta_number.toUpperCase() === userTa);
+    let explanation;
+    if (userTaEntry) {
+        explanation =
+            `User cited ${userTa} (${userTaEntry.title}) but the canonical NICE TA for ` +
+                `"${drug} ${indication}" is ${top.ta_number} (${top.title}). ` +
+                `${userTaEntry.notes ?? ""} ${top.notes ?? ""}`.trim();
+    }
+    else {
+        explanation =
+            `User cited ${userTa} but the canonical NICE TA for ` +
+                `"${drug} ${indication}" is ${top.ta_number} (${top.title}).`;
+    }
+    return {
+        user_supplied: userTa,
+        canonical: top.ta_number,
+        user_supplied_url: userTaEntry?.url,
+        canonical_url: top.url,
+        drug,
+        indication,
+        explanation,
+    };
+}
+/**
+ * Extract a TA number (e.g. "TA902") from arbitrary prose. Returns
+ * the first match or null. Used to scan e.g. evidence_summary for
+ * a TA number the user may have referenced informally.
+ */
+const TA_NUMBER_REGEX = /\b(TA\d{2,4})\b/i;
+export function extractTaNumber(text) {
+    const m = text.match(TA_NUMBER_REGEX);
+    return m ? m[1].toUpperCase() : null;
+}
+//# sourceMappingURL=niceTaPrecedents.js.map

package/dist/data/niceTaPrecedents.js.map

@@ -0,0 +1 @@
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package/dist/jca/scopeEligibility.d.ts

@@ -0,0 +1,55 @@
+/**
+ * EU JCA scope eligibility checker.
+ *
+ * Per Regulation (EU) 2021/2282, JCA scope is phased:
+ *   • From 12 January 2025: oncology medicinal products + ATMPs with
+ *     new active substances.
+ *   • From 13 January 2028: orphan medicinal products added.
+ *   • From 13 January 2030: all new medicinal products.
+ *
+ * Therefore, a request to produce a JCA PICO matrix for, e.g.,
+ * dapagliflozin in HFrEF (cardiovascular, small molecule) is asking
+ * for something that does not exist today and won't until 2030.
+ *
+ * This module exposes a pure function the `jca_pico_scope` tool calls
+ * before producing any output, so the tool can:
+ *   (a) refuse to produce a fabricated JCA matrix when the indication
+ *       is not in scope, AND
+ *   (b) explain the scope rule, the canonical Regulation reference,
+ *       and the year the indication WILL be in scope.
+ *
+ * This closes the gap that Claude.ai surfaced during the management
+ * benchmark — Claude.ai dynamically discovered the JCA scope reality
+ * via web search; HEORAgent now has it baked in.
+ *
+ * See design log #16.
+ */
+import type { IndicationCategory } from "./types.js";
+export type DrugClassForScope = "monoclonal_antibody" | "small_molecule" | "atmp_cell" | "atmp_gene" | "atmp_tissue" | "biosimilar" | "vaccine" | "radiopharmaceutical" | "other";
+export interface ScopeEligibility {
+    /** True if the indication-drug-class combo is currently in JCA scope. */
+    in_scope: boolean;
+    /** Year (Jan 13) the combo enters JCA scope per Reg 2021/2282. */
+    in_scope_from_year: 2025 | 2028 | 2030;
+    /** Phase that gates scope entry. */
+    phase: "oncology_atmp" | "orphan" | "all_medicinal";
+    /** Human-readable explanation suitable for surfacing in tool output. */
+    explanation: string;
+    /** Canonical Regulation references. */
+    references: string[];
+}
+/**
+ * Determine whether a drug-indication combo is currently in JCA scope.
+ *
+ * Inputs are the same shape `jca_pico_scope` already collects, so the
+ * tool can call this with no schema change. The optional `is_orphan`
+ * flag tells us whether the product is orphan-designated; when omitted,
+ * we conservatively assume not orphan so the function never falsely
+ * places a combo in 2028 scope.
+ */
+export declare function checkScopeEligibility(args: {
+    indication_category: IndicationCategory;
+    drug_class: DrugClassForScope;
+    is_orphan?: boolean;
+}): ScopeEligibility;
+//# sourceMappingURL=scopeEligibility.d.ts.map

package/dist/jca/scopeEligibility.d.ts.map

@@ -0,0 +1 @@
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package/dist/jca/scopeEligibility.js

@@ -0,0 +1,56 @@
+/**
+ * Determine whether a drug-indication combo is currently in JCA scope.
+ *
+ * Inputs are the same shape `jca_pico_scope` already collects, so the
+ * tool can call this with no schema change. The optional `is_orphan`
+ * flag tells us whether the product is orphan-designated; when omitted,
+ * we conservatively assume not orphan so the function never falsely
+ * places a combo in 2028 scope.
+ */
+export function checkScopeEligibility(args) {
+    const refs = [
+        "Regulation (EU) 2021/2282 (HTA Regulation), Article 7 — phased scope.",
+        "EU Implementing Regulation 2024/1381 — JCA procedural rules.",
+        "European Commission factsheet, JCA for Medicinal Products (Jan 2025): https://health.ec.europa.eu/document/download/ced91156-ffe1-472d-85eb-aa6a91dd707e_en?filename=hta_htar_factsheet-jca_en.pdf",
+    ];
+    // Phase 1 (in scope NOW, since 12 Jan 2025): oncology medicinal
+    // products + ATMP-class drugs (cell, gene, tissue) with new
+    // active substances.
+    const isOncology = args.indication_category === "oncology_nsclc" ||
+        args.indication_category === "oncology_other";
+    const isAtmp = args.drug_class === "atmp_cell" ||
+        args.drug_class === "atmp_gene" ||
+        args.drug_class === "atmp_tissue";
+    if (isOncology || isAtmp) {
+        return {
+            in_scope: true,
+            in_scope_from_year: 2025,
+            phase: "oncology_atmp",
+            explanation: "In JCA scope since 12 January 2025 (Phase 1: oncology medicinal products + ATMPs with new active substances).",
+            references: refs,
+        };
+    }
+    // Phase 2 (in scope from 13 Jan 2028): orphan-designated medicinal
+    // products. We treat this conservatively — only flag in-scope=true
+    // for orphan when the user explicitly sets is_orphan AND we're
+    // already past 2028. Since we can't predict the future, we always
+    // return out-of-scope today but with the right "in_scope_from_year".
+    if (args.is_orphan === true) {
+        return {
+            in_scope: false,
+            in_scope_from_year: 2028,
+            phase: "orphan",
+            explanation: "Orphan-designated medicinal products enter JCA scope from 13 January 2028 (Phase 2 of Reg 2021/2282). Until then, this indication is assessed at the national level only — produce a consolidated national-HTA PICO matrix instead.",
+            references: refs,
+        };
+    }
+    // Phase 3 (in scope from 13 Jan 2030): all new medicinal products.
+    return {
+        in_scope: false,
+        in_scope_from_year: 2030,
+        phase: "all_medicinal",
+        explanation: "Cardiovascular, metabolic, respiratory, neurology, infectious disease, rheumatology, IBD, and other non-oncology / non-ATMP indications enter JCA scope from 13 January 2030 (Phase 3 of Reg 2021/2282). Until then, this indication is assessed at the national level only — produce a consolidated national-HTA PICO matrix instead.",
+        references: refs,
+    };
+}
+//# sourceMappingURL=scopeEligibility.js.map

package/dist/jca/scopeEligibility.js.map

@@ -0,0 +1 @@
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package/dist/pv/decisionTree.d.ts

@@ -17,6 +17,8 @@ interface Decision {
     primary_category: PvCategory;
     alternatives: PvCategory[];
     rationale: string;
+    /** Optional advisory warnings surfaced from edge cases — handler attaches to audit. */
+    advisory_warnings?: string[];
 }
 export declare function classifyPv(input: PvClassifyInput): Decision;
 export {};

package/dist/pv/decisionTree.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"decisionTree.d.ts","sourceRoot":"","sources":["../../src/pv/decisionTree.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;;;GAaG;AACH,OAAO,KAAK,EAAE,UAAU,EAAE,eAAe,EAAE,MAAM,YAAY,CAAC;AAE9D,UAAU,QAAQ;IAChB,gBAAgB,EAAE,UAAU,CAAC;IAC7B,YAAY,EAAE,UAAU,EAAE,CAAC;IAC3B,SAAS,EAAE,MAAM,CAAC;IAClB,uFAAuF;IACvF,iBAAiB,CAAC,EAAE,MAAM,EAAE,CAAC;CAC9B;AAED,wBAAgB,UAAU,CAAC,KAAK,EAAE,eAAe,GAAG,QAAQ,CAmI3D"}

package/dist/pv/decisionTree.js

@@ -1,39 +1,75 @@
 export function classifyPv(input) {
-    // 1. Pre-authorisation: never PASS — characterise via ICH E2E plan.
+    // 1. Pre-authorisation: never PASS — characterise via ICH E2E plan
+    //    (which is an ICH guideline, NOT a GVP module). The plan informs
+    //    the initial RMP that's submitted at MA grant under GVP Module V.
     if (input.regulatory_context === "pre_authorisation") {
         return withPregnancyOverride(input, {
             primary_category: "ICH_E2E_pharmacovigilance_plan",
             alternatives: [],
-            rationale: "Study is pre-authorisation. PASS designations require an existing marketing authorisation (Article 107a). Pharmacovigilance planning at this stage falls under ICH E2E and feeds the initial RMP at MAA submission.",
+            rationale: "Study is pre-authorisation. PASS designations require an existing marketing authorisation (Article 107a). Pharmacovigilance planning at this stage falls under ICH E2E — note that ICH E2E is a standalone ICH guideline, not a GVP module; the GVP Module V reference reflects the downstream RMP that the E2E plan informs at MAA submission, not a direct mapping.",
         });
     }
     // 2. Spontaneous reports stand alone — Module VI baseline obligation.
+    //    imposed_by_authority is contradictory here (spontaneous reporting
+    //    is an inherent obligation, not something an authority can impose
+    //    as a study) — surface a warning rather than silently dropping the
+    //    flag.
     if (input.study_design === "spontaneous_reports") {
+        const warnings = input.imposed_by_authority
+            ? [
+                "Contradictory inputs: study_design='spontaneous_reports' AND imposed_by_authority=true. Spontaneous adverse-event reporting is an inherent PV obligation under GVP Module VI, not a designed study an authority can impose. The imposed_by_authority flag has been ignored.",
+            ]
+            : undefined;
         return withPregnancyOverride(input, {
             primary_category: "spontaneous_reporting_only",
             alternatives: [],
             rationale: "Spontaneous adverse-event reporting is the baseline PV obligation under GVP Module VI, not a designed study. Categorised as spontaneous_reporting_only.",
+            advisory_warnings: warnings,
         });
     }
-    // 3. RMP commitment context → Annex 4 listed study.
+    // 3. Imposed PASS takes precedence over plain RMP_Annex_4_study —
+    //    Article 107n imposition outranks Annex 4 listing. The Annex 4
+    //    listing is then a downstream consequence of the imposition.
+    if (input.imposed_by_authority) {
+        const warnings = [];
+        if ((input.regulatory_context === "conditional_approval" ||
+            input.regulatory_context === "accelerated_approval") &&
+            !input.imposed_by_authority) {
+            // dead branch (imposed=true above) — guarded for clarity if reordered
+        }
+        return withPregnancyOverride(input, {
+            primary_category: "PASS_imposed",
+            alternatives: input.regulatory_context === "rmp_commitment"
+                ? ["RMP_Annex_4_study"]
+                : ["RMP_Annex_4_study"],
+            rationale: input.regulatory_context === "rmp_commitment"
+                ? "Authority-imposed obligation that is also tracked as an RMP Annex 4 commitment. Article 107n imposition is the primary classification — the Annex 4 listing is a consequence, not the primary route. Falls under GVP Module VIII (PASS imposed); PRAC pre-review of the protocol is required."
+                : "Authority-imposed obligation in a post-authorisation context (Article 107n). Falls under GVP Module VIII as a Post-Authorisation Safety Study (imposed). PRAC pre-review of the protocol is required.",
+            advisory_warnings: warnings.length > 0 ? warnings : undefined,
+        });
+    }
+    // 4. RMP commitment context → Annex 4 listed study (when not imposed).
     if (input.regulatory_context === "rmp_commitment") {
-        const alts = input.imposed_by_authority
-            ? ["PASS_imposed"]
-            : ["PASS_voluntary"];
         return withPregnancyOverride(input, {
             primary_category: "RMP_Annex_4_study",
-            alternatives: alts,
+            alternatives: ["PASS_voluntary"],
             rationale: "Study is an explicit RMP commitment, listed in RMP Annex 4 with milestone tracking. Per EMA GVP Module V.",
         });
     }
-    // 4. Imposed PASS — applies to conditional, accelerated, and standard
-    //    post-authorisation contexts when the authority has imposed the
-    //    obligation (Article 107n / 107a).
-    if (input.imposed_by_authority) {
+    // 4a. Conditional / accelerated approval WITHOUT imposed_by_authority —
+    //     warn about Specific Obligations (CMA SOBs) per Article 14-a.
+    //     Falling through to objective-based classification but the user
+    //     should confirm whether the obligation is actually imposed.
+    if ((input.regulatory_context === "conditional_approval" ||
+        input.regulatory_context === "accelerated_approval") &&
+        !input.imposed_by_authority) {
+        const out = classifyByObjective(input);
         return withPregnancyOverride(input, {
-            primary_category: "PASS_imposed",
-            alternatives: ["RMP_Annex_4_study"],
-            rationale: "Authority-imposed obligation in a post-authorisation context (Article 107n). Falls under GVP Module VIII as a Post-Authorisation Safety Study (imposed). PRAC pre-review of the protocol is required.",
+            ...out,
+            advisory_warnings: [
+                ...(out.advisory_warnings ?? []),
+                `regulatory_context='${input.regulatory_context}' typically carries Specific Obligations (CMA Article 14-a / accelerated-approval SOBs) that function as an imposed PASS even without imposed_by_authority=true. Confirm SOB status with regulatory affairs; if confirmed, re-run with imposed_by_authority=true to get the correct PASS_imposed classification + Module VIII PRAC pre-review obligations.`,
+            ],
         });
     }
     // 5. Otherwise classify by primary objective + study design.
@@ -82,6 +118,7 @@ function withPregnancyOverride(input, decision) {
             alternatives: ["pregnancy_registry"],
             rationale: decision.rationale +
                 " Pregnancy population: a pregnancy registry will be required as a post-authorisation commitment per ICH E2E and EMA pregnancy-registry guidance.",
+            advisory_warnings: decision.advisory_warnings,
         };
     }
     if (decision.primary_category === "pregnancy_registry")
@@ -94,6 +131,47 @@ function withPregnancyOverride(input, decision) {
         rationale: "Pregnancy population in scope → pregnancy registry takes priority over the primary classification. " +
             decision.rationale +
             " The original classification is retained as an alternative for protocol-design context.",
+        advisory_warnings: decision.advisory_warnings,
     };
 }
+/**
+ * Pure classification by primary_objective. Extracted so the
+ * conditional_approval / accelerated_approval branch can reuse it without
+ * duplicating the switch.
+ */
+function classifyByObjective(input) {
+    switch (input.primary_objective) {
+        case "safety":
+            return {
+                primary_category: "PASS_voluntary",
+                alternatives: ["active_surveillance_registry"],
+                rationale: "Safety-objective post-authorisation study without an imposed obligation → voluntary PASS under GVP Module VIII.",
+            };
+        case "efficacy":
+        case "effectiveness":
+            return {
+                primary_category: "PAES",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Effectiveness/efficacy-objective post-authorisation study → Post-Authorisation Efficacy Study (PAES).",
+            };
+        case "drug_utilization":
+            return {
+                primary_category: "DUS",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Drug utilisation objective → DUS under GVP Module VIII Addendum I.",
+            };
+        case "natural_history":
+            return {
+                primary_category: "active_surveillance_registry",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Natural history / disease epidemiology objective → active surveillance registry.",
+            };
+        case "risk_minimisation_evaluation":
+            return {
+                primary_category: "PASS_voluntary",
+                alternatives: ["DUS"],
+                rationale: "Evaluation of risk-minimisation measure effectiveness → categorised as PASS (voluntary unless imposed).",
+            };
+    }
+}
 //# sourceMappingURL=decisionTree.js.map

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package/dist/pv/gvpModules.d.ts

@@ -9,7 +9,8 @@ import type { GvpModule, PvCategory } from "./types.js";
 export declare const GVP_REVISION: "rev_4";
 interface CategoryMapping {
     gvp_module: GvpModule;
-    encepp_protocol_template?: string;
+    /** Plain-language ENCePP category label — NOT a registered protocol ID. */
+    encepp_study_category?: string;
     rmp_implications: string[];
     fda_analogue?: string;
     submission_obligations: string[];

package/dist/pv/gvpModules.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"gvpModules.d.ts","sourceRoot":"","sources":["../../src/pv/gvpModules.ts"],"names":[],"mappings":"AAAA;;;;;;GAMG;AACH,OAAO,KAAK,EAAE,SAAS,EAAE,UAAU,EAAE,MAAM,YAAY,CAAC;AAExD,eAAO,MAAM,YAAY,EAAG,OAAgB,CAAC;AAE7C,UAAU,eAAe;IACvB,UAAU,EAAE,SAAS,CAAC;IACtB,2EAA2E;IAC3E,qBAAqB,CAAC,EAAE,MAAM,CAAC;IAC/B,gBAAgB,EAAE,MAAM,EAAE,CAAC;IAC3B,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,sBAAsB,EAAE,MAAM,EAAE,CAAC;CAClC;AAED,eAAO,MAAM,gBAAgB,EAAE,MAAM,CAAC,UAAU,EAAE,eAAe,CA2HhE,CAAC;AAEF,wBAAgB,MAAM,CAAC,QAAQ,EAAE,UAAU,GAAG,eAAe,CAE5D"}

package/dist/pv/gvpModules.js

@@ -2,7 +2,7 @@ export const GVP_REVISION = "rev_4";
 export const CATEGORY_MAPPING = {
     PASS_imposed: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PASS-001",
+        encepp_study_category: "PASS — post-authorisation safety study (imposed, GVP Module VIII). Use the ENCePP Code of Conduct checklist for protocol structure",
         rmp_implications: [
             "Update RMP Part III (PV Plan) to list this study as an imposed PASS.",
             "Annex 4 of the RMP must reference the protocol and timelines.",
@@ -16,7 +16,7 @@ export const CATEGORY_MAPPING = {
     },
     PASS_voluntary: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PASS-002",
+        encepp_study_category: "PASS — post-authorisation safety study (voluntary, GVP Module VIII). ENCePP registration in EUPAS encouraged",
         rmp_implications: [
             "Document study as a voluntary PASS in RMP Part III.",
             "No PRAC pre-approval required; encouraged ENCePP registration.",
@@ -29,7 +29,7 @@ export const CATEGORY_MAPPING = {
     },
     PAES: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PAES-001",
+        encepp_study_category: "PAES — post-authorisation efficacy study (GVP Module VIII)",
         rmp_implications: [
             "PAES results may trigger MA variation if effectiveness diverges from MA assumptions.",
         ],
@@ -41,7 +41,7 @@ export const CATEGORY_MAPPING = {
     },
     RMP_Annex_4_study: {
         gvp_module: "V",
-        encepp_protocol_template: "ENCePP-RMP-001",
+        encepp_study_category: "RMP Annex 4 study (GVP Module V)",
         rmp_implications: [
             "Listed in RMP Annex 4 with study ID, status, milestone dates.",
             "Study completion is a tracked RMP commitment.",
@@ -54,7 +54,7 @@ export const CATEGORY_MAPPING = {
     },
     DUS: {
         gvp_module: "VIII_Addendum_I",
-        encepp_protocol_template: "ENCePP-DUS-001",
+        encepp_study_category: "DUS — drug utilisation study (GVP Module VIII Addendum I)",
         rmp_implications: [
             "DUS may be referenced in RMP Part III for risk minimisation effectiveness.",
         ],
@@ -66,7 +66,7 @@ export const CATEGORY_MAPPING = {
     },
     active_surveillance_registry: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-REG-001",
+        encepp_study_category: "Active surveillance registry (GVP Module VIII)",
         rmp_implications: [
             "Registry serves as data source for ongoing PV signal detection in RMP Part III.",
         ],
@@ -78,7 +78,7 @@ export const CATEGORY_MAPPING = {
     },
     pregnancy_registry: {
         gvp_module: "VIII",
-        encepp_protocol_template: "ENCePP-PREG-001",
+        encepp_study_category: "Pregnancy registry (GVP Module VIII; refer to GVP Considerations P.III)",
         rmp_implications: [
             "Pregnancy registry is a standard RMP commitment for teratogenic-risk drugs (Annex 4).",
             "Outcomes feed into the Pregnancy section of every PSUR.",