Module 2.1 — CTD Table of Contents

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

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.