heor-agent-mcp 1.5.0 → 1.5.1
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/dist/irb/coverLetters.d.ts.map +1 -1
- package/dist/irb/coverLetters.js +4 -4
- package/dist/irb/coverLetters.js.map +1 -1
- package/dist/irb/decisionTree.d.ts.map +1 -1
- package/dist/irb/decisionTree.js +66 -15
- package/dist/irb/decisionTree.js.map +1 -1
- package/dist/irb/rulesets.d.ts +3 -3
- package/dist/irb/rulesets.d.ts.map +1 -1
- package/dist/irb/rulesets.js +4 -4
- package/dist/irb/rulesets.js.map +1 -1
- package/dist/irb/types.d.ts +1 -1
- package/dist/irb/types.d.ts.map +1 -1
- package/package.json +1 -1
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@@ -1 +1 @@
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1
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-
{"version":3,"file":"coverLetters.d.ts","sourceRoot":"","sources":["../../src/irb/coverLetters.ts"],"names":[],"mappings":"AAAA;;;;;;;;GAQG;AAEH,OAAO,KAAK,EACV,YAAY,EACZ,cAAc,EACd,YAAY,EACZ,YAAY,EACZ,YAAY,EACb,MAAM,YAAY,CAAC;
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{"version":3,"file":"coverLetters.d.ts","sourceRoot":"","sources":["../../src/irb/coverLetters.ts"],"names":[],"mappings":"AAAA;;;;;;;;GAQG;AAEH,OAAO,KAAK,EACV,YAAY,EACZ,cAAc,EACd,YAAY,EACZ,YAAY,EACZ,YAAY,EACb,MAAM,YAAY,CAAC;AAkCpB,wBAAgB,gBAAgB,CAAC,IAAI,EAAE;IACrC,KAAK,EAAE,cAAc,CAAC;IACtB,YAAY,EAAE,YAAY,GAAG,IAAI,CAAC;IAClC,YAAY,EAAE,YAAY,GAAG,IAAI,CAAC;IAClC,YAAY,EAAE,YAAY,CAAC;IAC3B,YAAY,EAAE,YAAY,CAAC;IAC3B,WAAW,EAAE,OAAO,CAAC;CACtB,GAAG,MAAM,CAwCT"}
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package/dist/irb/coverLetters.js
CHANGED
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@@ -25,10 +25,10 @@ const SAE_LABEL = {
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none: "No SAE-reporting framework (study design not subject to expedited safety reporting)",
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};
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const COI_LABEL = {
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phs_42_cfr_50: "PHS 42 CFR 50 Subpart F (Promoting Objectivity in Research)",
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-
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both: "PHS 42 CFR 50 Subpart F (US) and EU CTR 536/2014
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none: "No conflict-of-interest framework triggered (non-industry funding)",
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phs_42_cfr_50: "PHS 42 CFR 50 Subpart F (Promoting Objectivity in Research) — applies to all PHS-funded research (NIH, AHRQ, CDC) AND industry-funded US studies",
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eu_ctr_annex_i_point_66: "EU CTR 536/2014 Annex I, Section M, Point 66 (investigator suitability — declaration of economic interests and institutional affiliations affecting impartiality)",
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both: "PHS 42 CFR 50 Subpart F (US) and EU CTR 536/2014 Annex I §M Point 66 (EU)",
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none: "No conflict-of-interest framework triggered (non-PHS, non-industry funding outside EU)",
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};
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export function buildCoverLetter(args) {
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const { input, reviewTierUs, reviewTierEu, saeFramework, coiFramework } = args;
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@@ -1 +1 @@
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1
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-
{"version":3,"file":"coverLetters.js","sourceRoot":"","sources":["../../src/irb/coverLetters.ts"],"names":[],"mappings":"AAAA;;;;;;;;GAQG;AAUH,MAAM,aAAa,GAAiC;IAClD,MAAM,EAAE,0CAA0C;IAClD,SAAS,EAAE,sCAAsC;IACjD,UAAU,EAAE,uCAAuC;IACnD,cAAc,EAAE,8BAA8B;CAC/C,CAAC;AAEF,MAAM,aAAa,GAAiC;IAClD,aAAa,EAAE,wCAAwC;IACvD,eAAe,EACb,sEAAsE;IACxE,uBAAuB,EACrB,2FAA2F;CAC9F,CAAC;AAEF,MAAM,SAAS,GAAiC;IAC9C,YAAY,EAAE,iDAAiD;IAC/D,cAAc,EAAE,0CAA0C;IAC1D,mBAAmB,EACjB,gEAAgE;IAClE,IAAI,EAAE,qFAAqF;CAC5F,CAAC;AAEF,MAAM,SAAS,GAAiC;IAC9C,aAAa,EACX,
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{"version":3,"file":"coverLetters.js","sourceRoot":"","sources":["../../src/irb/coverLetters.ts"],"names":[],"mappings":"AAAA;;;;;;;;GAQG;AAUH,MAAM,aAAa,GAAiC;IAClD,MAAM,EAAE,0CAA0C;IAClD,SAAS,EAAE,sCAAsC;IACjD,UAAU,EAAE,uCAAuC;IACnD,cAAc,EAAE,8BAA8B;CAC/C,CAAC;AAEF,MAAM,aAAa,GAAiC;IAClD,aAAa,EAAE,wCAAwC;IACvD,eAAe,EACb,sEAAsE;IACxE,uBAAuB,EACrB,2FAA2F;CAC9F,CAAC;AAEF,MAAM,SAAS,GAAiC;IAC9C,YAAY,EAAE,iDAAiD;IAC/D,cAAc,EAAE,0CAA0C;IAC1D,mBAAmB,EACjB,gEAAgE;IAClE,IAAI,EAAE,qFAAqF;CAC5F,CAAC;AAEF,MAAM,SAAS,GAAiC;IAC9C,aAAa,EACX,kJAAkJ;IACpJ,uBAAuB,EACrB,mKAAmK;IACrK,IAAI,EAAE,2EAA2E;IACjF,IAAI,EAAE,wFAAwF;CAC/F,CAAC;AAEF,MAAM,UAAU,gBAAgB,CAAC,IAOhC;IACC,MAAM,EAAE,KAAK,EAAE,YAAY,EAAE,YAAY,EAAE,YAAY,EAAE,YAAY,EAAE,GACrE,IAAI,CAAC;IAEP,MAAM,MAAM,GAAG,YAAY,CAAC,CAAC,CAAC,aAAa,CAAC,YAAY,CAAC,CAAC,CAAC,CAAC,IAAI,CAAC;IACjE,MAAM,MAAM,GAAG,YAAY,CAAC,CAAC,CAAC,aAAa,CAAC,YAAY,CAAC,CAAC,CAAC,CAAC,IAAI,CAAC;IACjE,MAAM,KAAK,GAAG,CAAC,MAAM,EAAE,MAAM,CAAC,CAAC,MAAM,CAAC,OAAO,CAAC,CAAC,IAAI,CAAC,KAAK,CAAC,CAAC;IAC3D,MAAM,OAAO,GAAG,SAAS,CAAC,YAAY,CAAC,CAAC;IACxC,MAAM,OAAO,GAAG,SAAS,CAAC,YAAY,CAAC,CAAC;IAExC,MAAM,iBAAiB,GAAa,EAAE,CAAC;IACvC,IAAI,KAAK,CAAC,6BAA6B;QACrC,iBAAiB,CAAC,IAAI,CAAC,2CAA2C,CAAC,CAAC;IACtE,IAAI,KAAK,CAAC,4BAA4B;QACpC,iBAAiB,CAAC,IAAI,CAAC,yCAAyC,CAAC,CAAC;IACpE,IAAI,KAAK,CAAC,6BAA6B;QACrC,iBAAiB,CAAC,IAAI,CAAC,6CAA6C,CAAC,CAAC;IACxE,IAAI,KAAK,CAAC,yCAAyC;QACjD,iBAAiB,CAAC,IAAI,CAAC,mDAAmD,CAAC,CAAC;IAC9E,MAAM,cAAc,GAClB,iBAAiB,CAAC,MAAM,GAAG,CAAC;QAC1B,CAAC,CAAC,iCAAiC,iBAAiB,CAAC,IAAI,CAAC,IAAI,CAAC,kGAAkG;QACjK,CAAC,CAAC,EAAE,CAAC;IAET,OAAO;QACL,oEAAoE;QACpE,EAAE;QACF,0GAA0G,KAAK,CAAC,YAAY,OAAO,KAAK,CAAC,UAAU,gCAAgC,KAAK,CAAC,YAAY,CAAC,OAAO,CAAC,IAAI,EAAE,GAAG,CAAC,0CAA0C,KAAK,IAAI,+CAA+C,GAAG;QAC7T,EAAE;QACF,wBAAwB,KAAK,CAAC,UAAU,oCAAoC,KAAK,CAAC,aAAa,8IAA8I,cAAc,iCAAiC,OAAO,uEAAuE;QAC1W,EAAE;QACF,6DAA6D,KAAK,CAAC,cAAc,iCAAiC,OAAO,6EAA6E,KAAK,CAAC,UAAU,CAAC,CAAC,CAAC,+IAA+I,CAAC,CAAC,CAAC,EAAE,EAAE;QAC/W,EAAE;QACF,+PAA+P;QAC/P,EAAE;QACF,YAAY;QACZ,0BAA0B;QAC1B,eAAe;QACf,QAAQ;KACT,CAAC,IAAI,CAAC,IAAI,CAAC,CAAC;AACf,CAAC"}
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@@ -1 +1 @@
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1
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{"version":3,"file":"decisionTree.d.ts","sourceRoot":"","sources":["../../src/irb/decisionTree.ts"],"names":[],"mappings":"
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{"version":3,"file":"decisionTree.d.ts","sourceRoot":"","sources":["../../src/irb/decisionTree.ts"],"names":[],"mappings":"AA4BA,OAAO,EAML,KAAK,aAAa,EAClB,KAAK,cAAc,EAKpB,MAAM,YAAY,CAAC;AAklBpB,wBAAgB,SAAS,CAAC,KAAK,EAAE,cAAc,GAAG,aAAa,CA0E9D"}
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package/dist/irb/decisionTree.js
CHANGED
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@@ -20,7 +20,7 @@
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* See verification criteria 1-10 in design log #21 §"Verification Criteria".
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*/
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import { buildCoverLetter } from "./coverLetters.js";
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import { CTR_536_2014_TIMELINES, FDA_IND_TIMELINES, PSUR_TIMELINES, VULNERABLE_OBLIGATIONS } from "./rulesets.js";
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import { CTR_536_2014_TIMELINES, FDA_IND_TIMELINES, PSUR_TIMELINES, VULNERABLE_OBLIGATIONS, } from "./rulesets.js";
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import { IRB_RULESET, } from "./types.js";
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const NON_INTERVENTIONAL_DESIGNS = new Set([
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"questionnaire_only",
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@@ -53,7 +53,16 @@ function classifyUs(input, warnings) {
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rationale: "Risk classification was unknown for an interventional study; defaulted to full-board review under 45 CFR 46.108 (most protective).",
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};
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}
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// Surface contradictory hint inputs upfront — the hint switch below
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// silently ignores hints that don't match the study_design, which
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// confuses callers who set them deliberately.
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if (input.benign_behavioural && input.study_design !== "interventional") {
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warnings.push(`benign_behavioural=true requires study_design='interventional' per 45 CFR 46.104(d)(3); hint ignored because study_design is '${input.study_design}'.`);
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}
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// Hint-driven exempt categories (highest specificity first).
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// Precedence: educational → benign_behavioural → federal_demonstration →
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// taste_test → broad_consent_obtained × 2. Only one hint should be set
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// per call; if multiple are set, the first match in this order wins.
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if (input.exempt_category_hint === "educational") {
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return {
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tier: "exempt",
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@@ -114,10 +123,14 @@ function classifyUs(input, warnings) {
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tier: "exempt",
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exempt_category: 2,
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expedited_categories: [],
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rationale: "Educational tests, surveys, interviews, or public observation with non-identifiable responses (45 CFR 46.104(d)(2)).",
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rationale: "Educational tests, surveys, interviews, or public observation with non-identifiable responses (45 CFR 46.104(d)(2), first prong).",
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};
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}
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// Identifiable survey/interview → expedited cat 7.
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// §46.104(d)(2) has a SECOND prong (no-disclosure-risk) we don't
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// mechanise — surface as advisory so the IRB can apply it manually
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// for non-sensitive identifiable surveys.
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warnings.push("Questionnaire with identifiable responses classified as expedited cat 7. §46.104(d)(2) has a second prong (exempt if disclosure of responses outside research could not reasonably place subjects at risk) that this tool does not mechanise — confirm with the IRB whether exempt cat 2 may apply.");
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return {
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tier: "expedited",
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exempt_category: null,
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@@ -191,6 +204,9 @@ function classifyUs(input, warnings) {
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rationale: "Retrospective chart review using identifiable existing records at minimal risk (45 CFR 46.110 cat 5).",
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};
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}
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if (input.risk_level === "unknown") {
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warnings.push("risk_level was 'unknown' on a retrospective chart review with identifiable records — defaulted conservatively to full-board review. Re-run with risk_level set when finalised.");
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}
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return {
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tier: "full_board",
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exempt_category: null,
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};
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}
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if (input.risk_level === "greater_than_minimal") {
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if (input.marketed_drug) {
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warnings.push("marketed_drug=true was supplied but risk_level=greater_than_minimal — expedited cat 1 requires minimal risk. Defaulting to full-board; PSUR SAE framework still applies via marketed_drug flag.");
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}
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return {
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tier: "full_board",
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exempt_category: null,
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rationale: "Non-interventional prospective study at greater-than-minimal risk → full-board review (45 CFR 46.108).",
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};
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}
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if (input.risk_level === "unknown") {
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warnings.push("risk_level was 'unknown' on a non-interventional prospective study — defaulted conservatively to full-board review. Re-run with risk_level set when finalised.");
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return {
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tier: "full_board",
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exempt_category: null,
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expedited_categories: [],
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rationale: "Non-interventional prospective study with unknown risk classification → conservative full-board review.",
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};
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}
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return {
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tier: "expedited",
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exempt_category: null,
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rationale: "Registry using identifiable existing data at minimal risk (45 CFR 46.110 cat 5).",
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};
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}
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if (input.risk_level === "unknown") {
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warnings.push("risk_level was 'unknown' on a registry — defaulted conservatively to full-board review. Re-run with risk_level set when finalised.");
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}
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return {
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tier: "full_board",
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exempt_category: null,
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rationale: "Interventional study of a marketed drug at minimal risk per labeling (45 CFR 46.110 cat 1).",
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};
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}
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// Default: interventional
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//
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//
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// Default: interventional → full-board. Rationale text branches on
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// the actual risk_level so the report doesn't falsely claim
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// "greater-than-minimal" when the user supplied "minimal" — earlier
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// version always asserted the former, which read as a misclassification
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// back to the user.
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return {
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tier: "full_board",
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exempt_category: null,
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expedited_categories: [],
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rationale:
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rationale: input.risk_level === "minimal"
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? "Interventional study at minimal risk but no marketed-drug/device hint supplied — defaulted to full-board review under 45 CFR 46.108. If the product is a marketed drug or device used per labeling with no IND/IDE required, set marketed_drug=true to unlock expedited cat 1."
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: "Interventional drug / device / behavioural-intervention study at greater-than-minimal risk → full-board review under 45 CFR 46.108.",
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};
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}
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}
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}
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}
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if (hipaaPhi) {
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xfer.push("HIPAA §164.514
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xfer.push("HIPAA §164.514(b)(2) Safe Harbor (18-identifier removal) or §164.514(b)(1) Expert Determination required prior to data sharing outside the covered entity.");
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}
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return {
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gdpr_special_category: gdpr,
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}
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const isMinimal = input.risk_level === "minimal";
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const isNonInt = NON_INTERVENTIONAL_DESIGNS.has(input.study_design);
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// Benign-behavioural minimal-risk interventional studies (§46.104(d)(3)
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// exempt cat 3) warrant a basic ICF — the intervention is by definition
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// brief, harmless, and painless, so the consent is no more complex than
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// a non-interventional minimal-risk study.
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if (isMinimal && (isNonInt || input.benign_behavioural))
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return "basic";
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return "standard";
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}
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function computeCoi(input) {
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if (input.funding_source !== "industry") {
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return { required: false, framework: "none" };
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}
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const onUs = input.jurisdictions.includes("us_irb");
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const onEu = input.jurisdictions.includes("eu_cec");
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// PHS 42 CFR 50 Subpart F (FCOI regulation) applies to ALL Public Health
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// Service-funded research — NIH, AHRQ, CDC, HRSA, FDA, IHS, SAMHSA — plus
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// industry-funded US studies subject to the same disclosure obligations
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// when the institution is a PHS grantee. Pre-fix, this only fired for
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// industry funding, leaving NIH/CDC/AHRQ-funded studies with
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// coi_framework="none" — a real legal gap.
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const phsApplies = onUs &&
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(input.funding_source === "industry" ||
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input.funding_source === "nih" ||
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input.funding_source === "other_government");
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// EU CTR 536/2014 Annex I §M Point 66 disclosure of investigator economic
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// interests / institutional affiliations applies to industry-sponsored
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// trials (academic and government-funded EU trials are covered by national
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// ethics frameworks rather than CTR-specific COI sections).
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const euCtrApplies = onEu && input.funding_source === "industry";
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if (phsApplies && euCtrApplies)
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return { required: true, framework: "both" };
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if (
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if (phsApplies)
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return { required: true, framework: "phs_42_cfr_50" };
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if (
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|
-
return { required: true, framework: "
|
|
487
|
+
if (euCtrApplies)
|
|
488
|
+
return { required: true, framework: "eu_ctr_annex_i_point_66" };
|
|
438
489
|
return { required: false, framework: "none" };
|
|
439
490
|
}
|
|
440
491
|
function reconcileExpeditedClaim(input, derivedCategories, warnings) {
|
|
@@ -1 +1 @@
|
|
|
1
|
-
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1
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+
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package/dist/irb/rulesets.d.ts
CHANGED
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@@ -43,15 +43,15 @@ export declare const PSUR_TIMELINES: ReadonlyArray<{
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export declare const VULNERABLE_OBLIGATIONS: {
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readonly pregnant: {
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readonly regulatory_basis: "45 CFR 46 Subpart B (pregnant women, fetuses, neonates)";
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-
readonly obligations: readonly ["Risk to the fetus must be the least possible to achieve study objectives.", "Both
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+
readonly obligations: readonly ["Risk to the fetus must be the least possible to achieve study objectives.", "Both pregnant woman + father consent required (§46.204(e)) when research holds out the prospect of direct benefit SOLELY to the fetus — father's consent not required if unavailable, incompetent, temporarily incapacitated, or pregnancy resulted from rape or incest. When research has no direct benefit (at ≤ minimal fetal risk), only the pregnant woman's consent is required (§46.204(d)).", "No financial inducements to terminate pregnancy.", "EU CTR 536/2014 Article 33 — additional EC scrutiny for pregnant subjects in interventional trials."];
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};
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readonly prisoners: {
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readonly regulatory_basis: "45 CFR 46 Subpart C (prisoners)";
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-
readonly obligations: readonly ["Research must fall into one of the four permitted prisoner-research categories (§46.306)
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+
readonly obligations: readonly ["Research must fall into one of the four permitted prisoner-research categories (§46.306(a)(2)(i-iv)): (i) causes/effects of incarceration/criminal behavior (minimal risk only); (ii) study of prisons as institutions (minimal risk only); (iii) conditions particularly affecting prisoners as a class (requires Secretary consultation + Federal Register notice); (iv) practices likely to improve health/well-being of the individual subject — the most commonly invoked category for therapeutic research.", "IRB composition must include a prisoner advocate (§46.304: ≥1 IRB member must be a prisoner or prisoner representative).", "Risks must be commensurate with risks accepted by non-prisoner volunteers.", "Parole considerations cannot be tied to study participation; living conditions during study must be considered."];
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};
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readonly pediatric: {
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readonly regulatory_basis: "45 CFR 46 Subpart D (children)";
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-
readonly obligations: readonly ["Risk-tier classification: §46.404 (minimal risk)
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+
readonly obligations: readonly ["Risk-tier classification: §46.404 (minimal risk); §46.405 (greater-than-minimal with prospect of direct benefit); §46.406 (minor increase over minimal, no direct benefit, but ALSO requires the research be likely to yield generalizable knowledge about the subjects' disorder or condition — §46.406(c); cannot be applied to healthy-child studies unrelated to the enrolled population's disorder); §46.407 (otherwise unapprovable — requires HHS Secretary determination after expert-panel consultation and public comment period).", "Permission of parents (one parent for §46.404/405; both for §46.406/407 unless waived).", "Assent of the child when capable — IRB determines capability based on age and condition.", "EU CTR 536/2014 Article 32 — additional protections for paediatric subjects; Paediatric Investigation Plan (PIP) under EMA Reg. 1901/2006 may apply.", "v2_age_tier_table_pending: full state-by-state pediatric assent age table coming in v2."];
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};
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56
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readonly decisionally_impaired: {
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57
57
|
readonly regulatory_basis: "45 CFR 46.111(b) — additional safeguards for vulnerable subjects with diminished decision-making capacity";
|
|
@@ -1 +1 @@
|
|
|
1
|
-
{"version":3,"file":"rulesets.d.ts","sourceRoot":"","sources":["../../src/irb/rulesets.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;GAWG;AAEH,MAAM,WAAW,iBAAiB;IAChC,QAAQ,EAAE,MAAM,CAAC;IACjB,KAAK,EAAE,MAAM,CAAC;IACd,QAAQ,EAAE,MAAM,CAAC;IACjB,OAAO,EAAE,MAAM,CAAC;CACjB;AAED,eAAO,MAAM,iBAAiB,EAAE,aAAa,CAAC,iBAAiB,
|
|
1
|
+
{"version":3,"file":"rulesets.d.ts","sourceRoot":"","sources":["../../src/irb/rulesets.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;GAWG;AAEH,MAAM,WAAW,iBAAiB;IAChC,QAAQ,EAAE,MAAM,CAAC;IACjB,KAAK,EAAE,MAAM,CAAC;IACd,QAAQ,EAAE,MAAM,CAAC;IACjB,OAAO,EAAE,MAAM,CAAC;CACjB;AAED,eAAO,MAAM,iBAAiB,EAAE,aAAa,CAAC,iBAAiB,CA0D9D,CAAC;AAEF,MAAM,WAAW,oBAAoB;IACnC,QAAQ,EAAE,MAAM,CAAC;IACjB,KAAK,EAAE,MAAM,CAAC;IACd,QAAQ,EAAE,MAAM,CAAC;IACjB,OAAO,EAAE,MAAM,CAAC;CACjB;AAED,eAAO,MAAM,oBAAoB,EAAE,aAAa,CAAC,oBAAoB,CAoDpE,CAAC;AAEF,wEAAwE;AACxE,eAAO,MAAM,sBAAsB,EAAE,aAAa,CAAC;IACjD,UAAU,EAAE,MAAM,CAAC;IACnB,gBAAgB,EAAE,MAAM,CAAC;CAC1B,CAaA,CAAC;AAEF,0DAA0D;AAC1D,eAAO,MAAM,iBAAiB,EAAE,aAAa,CAAC;IAC5C,UAAU,EAAE,MAAM,CAAC;IACnB,gBAAgB,EAAE,MAAM,CAAC;CAC1B,CAcA,CAAC;AAEF,6CAA6C;AAC7C,eAAO,MAAM,cAAc,EAAE,aAAa,CAAC;IACzC,UAAU,EAAE,MAAM,CAAC;IACnB,gBAAgB,EAAE,MAAM,CAAC;CAC1B,CAcA,CAAC;AAEF,gDAAgD;AAChD,eAAO,MAAM,sBAAsB;;;;;;;;;;;;;;;;;CAuCzB,CAAC"}
|
package/dist/irb/rulesets.js
CHANGED
|
@@ -155,7 +155,7 @@ export const VULNERABLE_OBLIGATIONS = {
|
|
|
155
155
|
regulatory_basis: "45 CFR 46 Subpart B (pregnant women, fetuses, neonates)",
|
|
156
156
|
obligations: [
|
|
157
157
|
"Risk to the fetus must be the least possible to achieve study objectives.",
|
|
158
|
-
"Both
|
|
158
|
+
"Both pregnant woman + father consent required (§46.204(e)) when research holds out the prospect of direct benefit SOLELY to the fetus — father's consent not required if unavailable, incompetent, temporarily incapacitated, or pregnancy resulted from rape or incest. When research has no direct benefit (at ≤ minimal fetal risk), only the pregnant woman's consent is required (§46.204(d)).",
|
|
159
159
|
"No financial inducements to terminate pregnancy.",
|
|
160
160
|
"EU CTR 536/2014 Article 33 — additional EC scrutiny for pregnant subjects in interventional trials.",
|
|
161
161
|
],
|
|
@@ -163,8 +163,8 @@ export const VULNERABLE_OBLIGATIONS = {
|
|
|
163
163
|
prisoners: {
|
|
164
164
|
regulatory_basis: "45 CFR 46 Subpart C (prisoners)",
|
|
165
165
|
obligations: [
|
|
166
|
-
"Research must fall into one of the four permitted prisoner-research categories (§46.306)
|
|
167
|
-
"IRB composition must include a prisoner advocate (≥1 IRB member must be a prisoner or prisoner representative).",
|
|
166
|
+
"Research must fall into one of the four permitted prisoner-research categories (§46.306(a)(2)(i-iv)): (i) causes/effects of incarceration/criminal behavior (minimal risk only); (ii) study of prisons as institutions (minimal risk only); (iii) conditions particularly affecting prisoners as a class (requires Secretary consultation + Federal Register notice); (iv) practices likely to improve health/well-being of the individual subject — the most commonly invoked category for therapeutic research.",
|
|
167
|
+
"IRB composition must include a prisoner advocate (§46.304: ≥1 IRB member must be a prisoner or prisoner representative).",
|
|
168
168
|
"Risks must be commensurate with risks accepted by non-prisoner volunteers.",
|
|
169
169
|
"Parole considerations cannot be tied to study participation; living conditions during study must be considered.",
|
|
170
170
|
],
|
|
@@ -172,7 +172,7 @@ export const VULNERABLE_OBLIGATIONS = {
|
|
|
172
172
|
pediatric: {
|
|
173
173
|
regulatory_basis: "45 CFR 46 Subpart D (children)",
|
|
174
174
|
obligations: [
|
|
175
|
-
"Risk-tier classification: §46.404 (minimal risk)
|
|
175
|
+
"Risk-tier classification: §46.404 (minimal risk); §46.405 (greater-than-minimal with prospect of direct benefit); §46.406 (minor increase over minimal, no direct benefit, but ALSO requires the research be likely to yield generalizable knowledge about the subjects' disorder or condition — §46.406(c); cannot be applied to healthy-child studies unrelated to the enrolled population's disorder); §46.407 (otherwise unapprovable — requires HHS Secretary determination after expert-panel consultation and public comment period).",
|
|
176
176
|
"Permission of parents (one parent for §46.404/405; both for §46.406/407 unless waived).",
|
|
177
177
|
"Assent of the child when capable — IRB determines capability based on age and condition.",
|
|
178
178
|
"EU CTR 536/2014 Article 32 — additional protections for paediatric subjects; Paediatric Investigation Plan (PIP) under EMA Reg. 1901/2006 may apply.",
|
package/dist/irb/rulesets.js.map
CHANGED
|
@@ -1 +1 @@
|
|
|
1
|
-
{"version":3,"file":"rulesets.js","sourceRoot":"","sources":["../../src/irb/rulesets.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;GAWG;AASH,MAAM,CAAC,MAAM,iBAAiB,GAAqC;IACjE;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,2DAA2D;QAClE,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,sHAAsH;KACzH;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,
|
|
1
|
+
{"version":3,"file":"rulesets.js","sourceRoot":"","sources":["../../src/irb/rulesets.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;GAWG;AASH,MAAM,CAAC,MAAM,iBAAiB,GAAqC;IACjE;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,2DAA2D;QAClE,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,sHAAsH;KACzH;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,4DAA4D;QACnE,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,iOAAiO;KACpO;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,4CAA4C;QACnD,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,4MAA4M;KAC/M;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,4DAA4D;QACnE,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,uOAAuO;KAC1O;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,iEAAiE;QACxE,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,sJAAsJ;KACzJ;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,0DAA0D;QACjE,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,qNAAqN;KACxN;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EACH,sGAAsG;QACxG,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,+LAA+L;KAClM;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,uCAAuC;QAC9C,QAAQ,EAAE,qBAAqB;QAC/B,OAAO,EACL,yKAAyK;KAC5K;CACF,CAAC;AASF,MAAM,CAAC,MAAM,oBAAoB,GAAwC;IACvE;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,6DAA6D;QACpE,QAAQ,EAAE,4CAA4C;QACtD,OAAO,EACL,2OAA2O;KAC9O;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,2CAA2C;QAClD,QAAQ,EAAE,sBAAsB;QAChC,OAAO,EACL,+KAA+K;KAClL;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EACH,qEAAqE;QACvE,QAAQ,EAAE,sBAAsB;QAChC,OAAO,EACL,sJAAsJ;KACzJ;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,gDAAgD;QACvD,QAAQ,EAAE,sBAAsB;QAChC,OAAO,EACL,yIAAyI;KAC5I;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,gEAAgE;QACvE,QAAQ,EAAE,sBAAsB;QAChC,OAAO,EACL,qJAAqJ;KACxJ;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EAAE,iDAAiD;QACxD,QAAQ,EAAE,sBAAsB;QAChC,OAAO,EACL,gGAAgG;KACnG;IACD;QACE,QAAQ,EAAE,CAAC;QACX,KAAK,EACH,+EAA+E;QACjF,QAAQ,EAAE,sBAAsB;QAChC,OAAO,EACL,4MAA4M;KAC/M;CACF,CAAC;AAEF,wEAAwE;AACxE,MAAM,CAAC,MAAM,sBAAsB,GAG9B;IACH;QACE,UAAU,EAAE,iCAAiC;QAC7C,gBAAgB,EAAE,sCAAsC;KACzD;IACD;QACE,UAAU,EAAE,cAAc;QAC1B,gBAAgB,EAAE,UAAU;KAC7B;IACD;QACE,UAAU,EAAE,6BAA6B;QACzC,gBAAgB,EAAE,wCAAwC;KAC3D;CACF,CAAC;AAEF,0DAA0D;AAC1D,MAAM,CAAC,MAAM,iBAAiB,GAGzB;IACH;QACE,UAAU,EACR,iEAAiE;QACnE,gBAAgB,EAAE,4BAA4B;KAC/C;IACD;QACE,UAAU,EAAE,sDAAsD;QAClE,gBAAgB,EAAE,mBAAmB;KACtC;IACD;QACE,UAAU,EAAE,mBAAmB;QAC/B,gBAAgB,EAAE,UAAU;KAC7B;CACF,CAAC;AAEF,6CAA6C;AAC7C,MAAM,CAAC,MAAM,cAAc,GAGtB;IACH;QACE,UAAU,EAAE,sCAAsC;QAClD,gBAAgB,EACd,4FAA4F;KAC/F;IACD;QACE,UAAU,EAAE,kDAAkD;QAC9D,gBAAgB,EAAE,4BAA4B;KAC/C;IACD;QACE,UAAU,EAAE,sDAAsD;QAClE,gBAAgB,EAAE,4BAA4B;KAC/C;CACF,CAAC;AAEF,gDAAgD;AAChD,MAAM,CAAC,MAAM,sBAAsB,GAAG;IACpC,QAAQ,EAAE;QACR,gBAAgB,EAAE,yDAAyD;QAC3E,WAAW,EAAE;YACX,2EAA2E;YAC3E,qYAAqY;YACrY,kDAAkD;YAClD,qGAAqG;SACtG;KACF;IACD,SAAS,EAAE;QACT,gBAAgB,EAAE,iCAAiC;QACnD,WAAW,EAAE;YACX,mfAAmf;YACnf,0HAA0H;YAC1H,4EAA4E;YAC5E,iHAAiH;SAClH;KACF;IACD,SAAS,EAAE;QACT,gBAAgB,EAAE,gCAAgC;QAClD,WAAW,EAAE;YACX,8gBAA8gB;YAC9gB,yFAAyF;YACzF,0FAA0F;YAC1F,sJAAsJ;YACtJ,yFAAyF;SAC1F;KACF;IACD,qBAAqB,EAAE;QACrB,gBAAgB,EACd,2GAA2G;QAC7G,WAAW,EAAE;YACX,yEAAyE;YACzE,sGAAsG;YACtG,uCAAuC;YACvC,iIAAiI;SAClI;KACF;CACO,CAAC"}
|
package/dist/irb/types.d.ts
CHANGED
|
@@ -38,7 +38,7 @@ export interface SaeReportingObligations {
|
|
|
38
38
|
}>;
|
|
39
39
|
}
|
|
40
40
|
export type IcfTier = "basic" | "standard" | "complex";
|
|
41
|
-
export type CoiFramework = "phs_42_cfr_50" | "
|
|
41
|
+
export type CoiFramework = "phs_42_cfr_50" | "eu_ctr_annex_i_point_66" | "both" | "none";
|
|
42
42
|
export interface IrbAssessment {
|
|
43
43
|
review_tier_us: ReviewTierUs | null;
|
|
44
44
|
exempt_category_us: number | null;
|
package/dist/irb/types.d.ts.map
CHANGED
|
@@ -1 +1 @@
|
|
|
1
|
-
{"version":3,"file":"types.d.ts","sourceRoot":"","sources":["../../src/irb/types.ts"],"names":[],"mappings":"AAAA;;;;;;;;;GASG;AAEH,MAAM,MAAM,WAAW,GACnB,gBAAgB,GAChB,gCAAgC,GAChC,4BAA4B,GAC5B,UAAU,GACV,yBAAyB,GACzB,qBAAqB,GACrB,oBAAoB,CAAC;AAEzB,MAAM,MAAM,YAAY,GACpB,oBAAoB,GACpB,eAAe,GACf,wBAAwB,GACxB,iCAAiC,GACjC,gBAAgB,CAAC;AAErB,MAAM,MAAM,SAAS,GAAG,SAAS,GAAG,sBAAsB,GAAG,SAAS,CAAC;AAEvE,MAAM,MAAM,aAAa,GACrB,UAAU,GACV,KAAK,GACL,kBAAkB,GAClB,YAAY,GACZ,UAAU,GACV,MAAM,CAAC;AAEX,MAAM,MAAM,eAAe,GAAG,QAAQ,GAAG,QAAQ,GAAG,YAAY,GAAG,OAAO,CAAC;AAE3E,MAAM,MAAM,YAAY,GACpB,QAAQ,GACR,WAAW,GACX,YAAY,GACZ,gBAAgB,CAAC;AAErB,MAAM,MAAM,YAAY,GACpB,eAAe,GACf,iBAAiB,GACjB,yBAAyB,CAAC;AAE9B,MAAM,MAAM,eAAe,GACvB,WAAW,GACX,UAAU,GACV,WAAW,GACX,uBAAuB,CAAC;AAE5B,MAAM,WAAW,8BAA8B;IAC7C,KAAK,EAAE,eAAe,CAAC;IACvB,gBAAgB,EAAE,MAAM,CAAC;IACzB,WAAW,EAAE,MAAM,EAAE,CAAC;IACtB,yBAAyB,EAAE,OAAO,CAAC;CACpC;AAED,MAAM,MAAM,UAAU,GAClB,aAAa,GACb,sBAAsB,GACtB,kBAAkB,GAClB,cAAc,GACd,gBAAgB,CAAC;AAErB,MAAM,WAAW,kBAAkB;IACjC,qBAAqB,EAAE,OAAO,CAAC;IAC/B,SAAS,EAAE,OAAO,CAAC;IACnB,wBAAwB,EAAE,UAAU,CAAC;IACrC,iCAAiC,EAAE,MAAM,EAAE,CAAC;CAC7C;AAED,MAAM,MAAM,YAAY,GACpB,cAAc,GACd,gBAAgB,GAChB,qBAAqB,GACrB,MAAM,CAAC;AAEX,MAAM,WAAW,uBAAuB;IACtC,SAAS,EAAE,YAAY,CAAC;IACxB,SAAS,EAAE,KAAK,CAAC;QACf,UAAU,EAAE,MAAM,CAAC;QACnB,gBAAgB,EAAE,MAAM,CAAC;KAC1B,CAAC,CAAC;CACJ;AAED,MAAM,MAAM,OAAO,GAAG,OAAO,GAAG,UAAU,GAAG,SAAS,CAAC;AAEvD,MAAM,MAAM,YAAY,GACpB,eAAe,GACf,
|
|
1
|
+
{"version":3,"file":"types.d.ts","sourceRoot":"","sources":["../../src/irb/types.ts"],"names":[],"mappings":"AAAA;;;;;;;;;GASG;AAEH,MAAM,MAAM,WAAW,GACnB,gBAAgB,GAChB,gCAAgC,GAChC,4BAA4B,GAC5B,UAAU,GACV,yBAAyB,GACzB,qBAAqB,GACrB,oBAAoB,CAAC;AAEzB,MAAM,MAAM,YAAY,GACpB,oBAAoB,GACpB,eAAe,GACf,wBAAwB,GACxB,iCAAiC,GACjC,gBAAgB,CAAC;AAErB,MAAM,MAAM,SAAS,GAAG,SAAS,GAAG,sBAAsB,GAAG,SAAS,CAAC;AAEvE,MAAM,MAAM,aAAa,GACrB,UAAU,GACV,KAAK,GACL,kBAAkB,GAClB,YAAY,GACZ,UAAU,GACV,MAAM,CAAC;AAEX,MAAM,MAAM,eAAe,GAAG,QAAQ,GAAG,QAAQ,GAAG,YAAY,GAAG,OAAO,CAAC;AAE3E,MAAM,MAAM,YAAY,GACpB,QAAQ,GACR,WAAW,GACX,YAAY,GACZ,gBAAgB,CAAC;AAErB,MAAM,MAAM,YAAY,GACpB,eAAe,GACf,iBAAiB,GACjB,yBAAyB,CAAC;AAE9B,MAAM,MAAM,eAAe,GACvB,WAAW,GACX,UAAU,GACV,WAAW,GACX,uBAAuB,CAAC;AAE5B,MAAM,WAAW,8BAA8B;IAC7C,KAAK,EAAE,eAAe,CAAC;IACvB,gBAAgB,EAAE,MAAM,CAAC;IACzB,WAAW,EAAE,MAAM,EAAE,CAAC;IACtB,yBAAyB,EAAE,OAAO,CAAC;CACpC;AAED,MAAM,MAAM,UAAU,GAClB,aAAa,GACb,sBAAsB,GACtB,kBAAkB,GAClB,cAAc,GACd,gBAAgB,CAAC;AAErB,MAAM,WAAW,kBAAkB;IACjC,qBAAqB,EAAE,OAAO,CAAC;IAC/B,SAAS,EAAE,OAAO,CAAC;IACnB,wBAAwB,EAAE,UAAU,CAAC;IACrC,iCAAiC,EAAE,MAAM,EAAE,CAAC;CAC7C;AAED,MAAM,MAAM,YAAY,GACpB,cAAc,GACd,gBAAgB,GAChB,qBAAqB,GACrB,MAAM,CAAC;AAEX,MAAM,WAAW,uBAAuB;IACtC,SAAS,EAAE,YAAY,CAAC;IACxB,SAAS,EAAE,KAAK,CAAC;QACf,UAAU,EAAE,MAAM,CAAC;QACnB,gBAAgB,EAAE,MAAM,CAAC;KAC1B,CAAC,CAAC;CACJ;AAED,MAAM,MAAM,OAAO,GAAG,OAAO,GAAG,UAAU,GAAG,SAAS,CAAC;AAEvD,MAAM,MAAM,YAAY,GACpB,eAAe,GACf,yBAAyB,GACzB,MAAM,GACN,MAAM,CAAC;AAEX,MAAM,WAAW,aAAa;IAC5B,cAAc,EAAE,YAAY,GAAG,IAAI,CAAC;IACpC,kBAAkB,EAAE,MAAM,GAAG,IAAI,CAAC;IAClC,uBAAuB,EAAE,MAAM,EAAE,CAAC;IAClC,cAAc,EAAE,YAAY,GAAG,IAAI,CAAC;IACpC,oBAAoB,EAAE,MAAM,GAAG,IAAI,CAAC;IACpC,iCAAiC,EAAE,8BAA8B,EAAE,CAAC;IACpE,oBAAoB,EAAE,kBAAkB,CAAC;IACzC,yBAAyB,EAAE,uBAAuB,CAAC;IACnD,mBAAmB,EAAE,OAAO,CAAC;IAC7B,uBAAuB,EAAE,OAAO,CAAC;IACjC,aAAa,EAAE,YAAY,CAAC;IAC5B,qBAAqB,EAAE,MAAM,CAAC;IAC9B,SAAS,EAAE,MAAM,CAAC;IAClB,iBAAiB,EAAE,MAAM,EAAE,CAAC;IAC5B,WAAW,EAAE,SAAS,CAAC;CACxB;AAED,MAAM,WAAW,cAAc;IAC7B,YAAY,EAAE,WAAW,CAAC;IAC1B,YAAY,EAAE,MAAM,CAAC;IACrB,UAAU,EAAE,MAAM,CAAC;IACnB,6BAA6B,EAAE,OAAO,CAAC;IACvC,4BAA4B,EAAE,OAAO,CAAC;IACtC,6BAA6B,EAAE,OAAO,CAAC;IACvC,yCAAyC,EAAE,OAAO,CAAC;IACnD,aAAa,EAAE,eAAe,EAAE,CAAC;IACjC,aAAa,EAAE,YAAY,CAAC;IAC5B,UAAU,EAAE,SAAS,CAAC;IACtB,cAAc,EAAE,aAAa,CAAC;IAC9B,UAAU,EAAE,OAAO,CAAC;IACpB,wBAAwB,CAAC,EAAE,MAAM,EAAE,CAAC;IACpC,+EAA+E;IAC/E,iBAAiB,CAAC,EAAE;QAAE,gBAAgB,CAAC,EAAE,MAAM,CAAA;KAAE,GAAG,SAAS,CAAC;IAC9D;;;;;;;;;;;;;;;;OAgBG;IACH,oBAAoB,CAAC,EAAE,aAAa,CAAC;IACrC,kBAAkB,CAAC,EAAE,OAAO,CAAC;IAC7B,qBAAqB,CAAC,EAAE,OAAO,CAAC;IAChC,UAAU,CAAC,EAAE,OAAO,CAAC;IACrB,sBAAsB,CAAC,EAAE,OAAO,CAAC;IACjC,aAAa,CAAC,EAAE,OAAO,CAAC;IACxB,wBAAwB,CAAC,EAAE,OAAO,CAAC;IACnC,sBAAsB,CAAC,EAAE,OAAO,CAAC;IACjC,qBAAqB,CAAC,EAAE,OAAO,CAAC;IAChC,oBAAoB,CAAC,EAAE,OAAO,CAAC;CAChC;AAED,eAAO,MAAM,WAAW,EAAG,SAAkB,CAAC"}
|