📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.

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About this document — a plain-language guide

What it is. The CTD table of contents for the whole submission — the map of Modules 2 through 5.

Why it exists. A marketing application is thousands of pages; reviewers navigate it through this standardized ICH table of contents. It shows how the dossier is organized and where each report lives.

How it is produced here. It contains no new data. It is a distillation — it gathers, summarizes, and cross-references the underlying study reports and datasets into the shorter form a regulator reads first.

Format & governing standard. ICH M4 (CTD)

Module 2.1 — CTD Table of Contents

Field	Value
Document ID	M21
Version	1.0
Compound	GLPI-103 (GLP-1/APJ dual agonist)
Standard	ICH M4 (CTD)
Confidentiality	Confidential — portfolio use

Table of Contents for CTD Modules 2–5 (and Module 1 regional). A navigable, hyperlinked version is generated at outputs/ectd/0000/index.html.

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Regulatory	Initial CTD ToC

Module 1 — Regional / Administrative

1.x Administrative documents & certifications index (M1-0): forms, financial disclosure, debarment, environmental, patent/exclusivity, user fee
1.x US: M1-US (cover letter, 356h summary, USPI, Medication Guide); REMS assessment (RMP-US)
1.x EU: M1-EU (cover letter, application form, SmPC); EU-RMP (RMP-EU)
1.x KR: M1-KR (표지서한, 신청서, 허가사항); MFDS RMP (RMP-KR)
1.x Clinical-trial applications: IND (US), IMPD (EU), CTA (KR); Pediatric plan (PSP/PIP)
1.x Agency meetings (briefing documents): Pre-IND (MTG-PREIND), End-of-Phase-2 (MTG-EOP2), Pre-NDA (MTG-PRENDA); expedited-program requests (DESIG-001)
1.x Pharmacovigilance: DSUR (DSUR-001), PBRER/PSUR (PSUR-001), Signal Management Plan (SIGNAL-001)

Module 2 — CTD Summaries

2.1 CTD Table of Contents (this document)
2.2 Introduction (M22)
2.3 Quality Overall Summary (M23)
2.4 Nonclinical Overview (M24)
2.5 Clinical Overview (M25) · 2.5.6 Benefit–Risk (M256)
2.6 Nonclinical Written & Tabulated Summaries (M26)
2.7 Clinical Summary: 2.7.1 Biopharmaceutics (M271) · 2.7.2 Clinical Pharmacology (M272) · 2.7.3 Efficacy (M273) · 2.7.4 Safety (M274) · 2.7.5 Literature References (M275) · 2.7.6 Synopses of Individual Studies (M276)

Module 3 — Quality

3.2.S / 3.2.P Quality summary (M3); detailed drug-substance (M3-S) and drug-product (M3-P) sections

Module 4 — Nonclinical Study Reports

4.2.1 Pharmacology · 4.2.2 Pharmacokinetics · 4.2.3 Toxicology (study-report stubs, M4-*)
Nonclinical data (SEND): nonclinical data reviewer's guide / nSDRG (SEND-001)

Module 5 — Clinical Study Reports

5.2 Tabular Listing of All Clinical Studies (M52)
5.3.1 Biopharmaceutic studies (CLINPHARM-001); bioanalytical method validation (BIOANALYTICAL-001)
5.3.3 Human PK studies — SAD/MAD, population PK & exposure–response, hepatic/renal impairment, DDI (CLINPHARM-002); immunogenicity (IMMUNO-001)
5.3.4 Human PD & cardiac-safety (QT) studies (CLINPHARM-003)
5.3.5 Reports of Efficacy/Safety Studies: PROT-301, SAP-301, SAR-301 (statistical analysis report), CSR-301 (+ Appendix 16.3 patient narratives, CSR-301-N); CSR-101, CSR-102, CSR-201
5.3.5.3 Integrated summaries: ISE-301 (efficacy), ISS-301 (safety)
5.3 Data: define.xml, SDRG, ADRG, ARM-301 (analysis results metadata), validation report
Annotated CRF (aCRF), blank CRF; Investigator's Brochure (IB-001)

Supporting (internal — not eCTD leaves)

Project management (PM-001…007, incl. Clinical Development Plan), TMF (ICF, DMP, Monitoring Plan, DSMB Charter/Minutes, Randomization/IWRS Spec, Safety Mgmt Plan, Pharmacy/IMP, Lab Manual, CTA/IRB), Quality (QMP, Deviation Log, Issue/CAPA Log, Decision Log) — see outputs/ectd/0000/index.html Supporting section and planning/master_document_index.md.