check_ctd_completeness
Identifies gaps in a list of CTD sections by comparing them against required sections for NDA, BLA, or MAA submissions in modules 3, 4, or 5.
Instructions
Check a list of provided CTD sections against required sections and identify gaps.
Input Schema
TableJSON Schema
| Name | Required | Description | Default |
|---|---|---|---|
| provided_sections | Yes | List of CTD sections already prepared | |
| submission_type | Yes | Target submission type: 'NDA', 'BLA', or 'MAA' | |
| module | Yes | Which module to check: '3', '4', or '5' |
Implementation Reference
- src/index.ts:285-297 (registration)Registration of the 'check_ctd_completeness' tool in the ListToolsRequestSchema handler, defining its name, description, and inputSchema (provided_sections, submission_type, module).
{ name: "check_ctd_completeness", description: "Check a list of provided CTD sections against required sections and identify gaps.", inputSchema: { type: "object", properties: { provided_sections: { type: "array", items: { type: "string" }, description: "List of CTD sections already prepared" }, submission_type: { type: "string", description: "Target submission type: 'NDA', 'BLA', or 'MAA'" }, module: { type: "string", description: "Which module to check: '3', '4', or '5'" } }, required: ["provided_sections", "submission_type", "module"] } }, - src/index.ts:360-369 (handler)Core handler function for 'check_ctd_completeness'. Parses arguments, looks up CTD_MODULES data, calculates provided vs missing sections using prefix matching, computes a completeness score percentage, and returns a formatted result.
if (name === "check_ctd_completeness") { const { provided_sections, submission_type, module } = z.object({ provided_sections: z.array(z.string()), submission_type: z.string(), module: z.string() }).parse(args); const moduleData = CTD_MODULES[module]; if (!moduleData) return { content: [{ type: "text", text: "Module " + module + " not found." }] }; const allRequired = Object.keys(moduleData.sections); const missing = allRequired.filter(s => !provided_sections.some(p => p.startsWith(s) || s.startsWith(p))); const provided = allRequired.filter(s => provided_sections.some(p => p.startsWith(s) || s.startsWith(p))); const score = Math.round((provided.length / allRequired.length) * 100); return { content: [{ type: "text", text: "# CTD Module " + module + " Completeness Check\n**Submission:** " + submission_type + "\n**Score:** " + score + "%\n\n**Provided (" + provided.length + "):**\n" + provided.map(s => "- " + s + ": " + moduleData.sections[s]).join("\n") + "\n\n**Missing (" + missing.length + "):**\n" + missing.map(s => "- " + s + ": " + moduleData.sections[s]).join("\n") }] }; } - src/index.ts:116-198 (helper)The CTD_MODULES constant defining all CTD module data (sections and descriptions) used by the handler to determine required sections for modules 1-5.
const CTD_MODULES: Record<string, { title: string; sections: Record<string, string>; submissionType: string[] }> = { "1": { title: "Regional Administrative Information", sections: { "1.1": "Comprehensive Table of Contents", "1.2": "Application Forms", "1.3": "Product Information (PI / SmPC / Package Insert)", "1.4": "Information about the Experts", "1.5": "Specific Requirements for Different Types of Applications", "1.6": "Environmental Risk Assessment", "1.7": "Information relating to Pharmacovigilance", "1.8": "Information relating to Clinical Trials (EudraCT)", "1.9": "Information relating to Paediatrics", "1.10": "Information about Pharmacovigilance System", "1.11": "Summary of the Risk Management System" }, submissionType: ["NDA", "BLA", "MAA", "JNDA"] }, "2": { title: "Common Technical Document Summaries", sections: { "2.1": "CTD Table of Contents", "2.2": "CTD Introduction", "2.3": "Quality Overall Summary (QOS)", "2.4": "Nonclinical Overview", "2.5": "Clinical Overview", "2.6": "Nonclinical Written and Tabulated Summaries", "2.7": "Clinical Summary" }, submissionType: ["NDA", "BLA", "MAA", "JNDA"] }, "3": { title: "Quality", sections: { "3.1": "Table of Contents of Module 3", "3.2.S": "Drug Substance (API)", "3.2.S.1": "General Information (nomenclature, structure, properties)", "3.2.S.2": "Manufacture (manufacturer, process, controls, validation)", "3.2.S.3": "Characterisation (structure elucidation, impurities)", "3.2.S.4": "Control of Drug Substance (specifications, methods, validation)", "3.2.S.5": "Reference Standards or Materials", "3.2.S.6": "Container Closure System", "3.2.S.7": "Stability", "3.2.P": "Drug Product (Finished Product)", "3.2.P.1": "Description and Composition", "3.2.P.2": "Pharmaceutical Development", "3.2.P.3": "Manufacture", "3.2.P.4": "Control of Excipients", "3.2.P.5": "Control of Drug Product (specifications, methods, validation)", "3.2.P.6": "Reference Standards or Materials", "3.2.P.7": "Container Closure System", "3.2.P.8": "Stability", "3.2.A": "Appendices", "3.2.R": "Regional Information" }, submissionType: ["NDA", "BLA", "MAA", "JNDA"] }, "4": { title: "Nonclinical Study Reports", sections: { "4.1": "Table of Contents", "4.2.1": "Pharmacology (primary, secondary, safety pharmacology)", "4.2.2": "Pharmacokinetics (absorption, distribution, metabolism, excretion)", "4.2.3": "Toxicology (single/repeat dose, genotoxicity, carcinogenicity, reproductive)" }, submissionType: ["NDA", "BLA", "MAA", "JNDA"] }, "5": { title: "Clinical Study Reports", sections: { "5.1": "Table of Contents", "5.2": "Tabular Listing of All Clinical Studies", "5.3.1": "Reports of Biopharmaceutic Studies", "5.3.2": "Reports of Studies Pertinent to Pharmacokinetics", "5.3.3": "Reports of Human PK Studies", "5.3.4": "Reports of Human PD Studies", "5.3.5": "Reports of Efficacy and Safety Studies", "5.3.6": "Reports of Post-marketing Experience", "5.3.7": "Case Report Forms and Individual Patient Listings" }, submissionType: ["NDA", "BLA", "MAA", "JNDA"] } };