Samples / GLPI-103

GLPI-103 — Type 2 Diabetes Mellitus

From study definition to dossier

One study.yaml drives every step; the dossier engine regenerates all of it from source.

Numbers the gate traced

The engine's reconciliation gate recomputed these 23 values from the analysis outputs and found each one in the dossier text. Re-run at build time; a mismatch stops the build.

Requirements chain

From the target product profile claim to the CSR section, the analysis and the artefact that carries the number.

Dossier (100 documents)

program-management

• Program & Project Management — Index
• Project Charter — GLPI-103 Development Program
• Integrated Program Timeline & Milestones — GLPI-103
• Clinical Program Budget & Cost Model — GLPI-103
• Project Risk Register — GLPI-103 Development Program
• Governance & RACI / Phase-Gate Criteria — GLPI-103
• Resource & Vendor (CRO) Management Plan — GLPI-103
• Clinical Development Plan (CDP) — GLPI-103

quality

• Quality Management Plan (QMP) — GLPI103-301 Program
• Protocol Deviation Log — GLPI103-301
• Issue & CAPA Log — GLPI-103 Program
• Decision & Action-Item Log — GLPI-103 Program

regulatory/_reference

• Clinical Program Parameters — Canonical Reference
• Target Product Profile (TPP) — GLPI-103

regulatory

• RAPL Dossier Regulatory Documentation — Style Guide & Document Control Conventions

regulatory/_templates

• <Document Title>

regulatory/m1

• EU MAA — Application Form (eAF) & Cover Letter — GLPI-103
• EU Investigational Medicinal Product Dossier (IMPD) — Summary — GLPI-103
• Module 1 (EU) — Administrative & Summary of Product Characteristics — GLPI-103
• EU Risk Management Plan (EU-RMP) — GLPI-103
• US NDA — Form FDA 356h, Cover Letter & Administrative Certifications — GLPI-103
• US Investigational New Drug (IND) Application — Summary — GLPI-103
• Module 1 (US) — Administrative & US Prescribing Information — GLPI-103
• FDA Risk Management & REMS Assessment — GLPI-103
• Module 1 — Administrative Documents & Certifications Index — GLPI-103
• Expedited Program Designation Requests — GLPI-103
• End-of-Phase-2 (EOP2) Meeting Briefing Document — GLPI-103
• Pre-IND Meeting Briefing Document — GLPI-103
• Pre-NDA Meeting Briefing Document — GLPI-103
• 임상시험계획승인신청(IND) 요약 — GLPI-103 (MFDS)
• 품목허가신청서 및 표지서한 (MFDS) — GLPI-103
• Module 1 (Korea) — 행정정보 및 허가사항(라벨) — GLPI-103
• MFDS Risk Management Plan (위해성 관리 계획, RMP) — GLPI-103
• Pediatric Plan (US PSP / EU PIP) — GLPI-103
• Development Safety Update Report (DSUR) — GLPI-103
• Periodic Benefit-Risk Evaluation Report (PBRER/PSUR) — GLPI-103
• Signal Management Plan — GLPI-103

regulatory/m2

• Module 2.1 — CTD Table of Contents
• Module 2.2 — Introduction
• Module 2.3 — Quality Overall Summary (QOS) — GLPI-103
• Module 2.4 — Nonclinical Overview
• Module 2.5.6 — Benefits and Risks Conclusions
• Module 2.5 — Clinical Overview
• Module 2.6 — Nonclinical Written & Tabulated Summaries
• Module 2.7.1 — Summary of Biopharmaceutic Studies & Associated Analytical Methods
• Module 2.7.2 — Summary of Clinical Pharmacology Studies
• Module 2.7.3 — Summary of Clinical Efficacy
• Module 2.7.4 — Summary of Clinical Safety
• Module 2.7.5 — Literature References
• Module 2.7.6 — Synopses of Individual Studies

regulatory/m3-quality

• Analytical Methods & Validation Summary — GLPI-103
• Module 3.2.A Appendices & 3.2.R Regional Information — GLPI-103
• Control Strategy — GLPI-103
• Module 3.2.P — Drug Product (Full) — GLPI-103
• Process Development & Validation Summary — GLPI-103
• Quality Target Product Profile (QTPP) & Critical Quality Attributes (CQA) — GLPI-103
• Module 3.2.S — Drug Substance (Full) — GLPI-103
• Stability Summary — GLPI-103
• Module 3 — Quality (CMC) — GLPI-103

regulatory/m4-nonclinical

• Module 4.2.1 — Pharmacology Study Reports — GLPI-103
• Module 4.2.2 — Pharmacokinetic Study Reports — GLPI-103
• Module 4.2.3 — Toxicology Study Reports — GLPI-103
• Module 4 — Nonclinical Study Reports (Index & Stubs) — GLPI-103
• Nonclinical Data Reviewer's Guide (nSDRG) — SEND — GLPI-103

regulatory/m5-clinical

• Bioanalytical Method Validation Summary — GLPI-103 (PK Assay & Anti-Drug-Antibody Assay)
• Summary of Biopharmaceutic Study Reports — GLPI-103
• Summary of Human Pharmacokinetic Study Reports — GLPI-103
• Summary of Human Pharmacodynamic and Cardiac-Safety (QT) Study Reports — GLPI-103
• Immunogenicity Summary Report — GLPI-103
• Annotated Case Report Form (aCRF) — GLPI103-301
• Blank Case Report Form (CRF) — GLPI103-301
• Clinical Study Report (Abbreviated) — GLPI103-101 (FIH / SAD)
• Clinical Study Report (Abbreviated) — GLPI103-102 (MAD / early efficacy)
• Clinical Study Report (Abbreviated) — GLPI103-201 (Phase 2 PoC / dose-finding)
• Patient Narratives — Deaths, Serious Adverse Events, and Adverse-Event Discontinuations — GLPI103-301
• Clinical Study Report — GLPI103-301
• Analysis Results Metadata (ARM) — GLPI103-301
• Analysis Data Reviewer's Guide (ADRG) — GLPI103-301
• Study Data Reviewer's Guide (SDRG) — GLPI103-301
• CDISC Conformance Validation Report — GLPI103-301
• Investigator's Brochure — GLPI-103
• Integrated Summary of Efficacy (ISE) — GLPI-103
• Integrated Summary of Safety (ISS) — GLPI-103
• Module 5.2 — Tabular Listing of All Clinical Studies
• Clinical Study Protocol — GLPI103-301
• ADaM Dataset Specification — GLPI103-301
• Statistical Analysis Plan — GLPI103-301
• Statistical Analysis Report — GLPI103-301
• Tables, Listings & Figures (TLF) Shells — GLPI103-301

tmf

• Trial Master File (TMF) — Index
• Informed Consent Form (ICF) — GLPI103-301 (master template)
• Data Management Plan (DMP) — GLPI103-301
• Clinical Monitoring Plan (CMP) — GLPI103-301
• Data Safety Monitoring Board (DSMB) Charter — GLPI103-301
• Randomization & IWRS Specification + UAT — GLPI103-301
• Safety Management Plan (SMP) — GLPI103-301
• DSMB Meeting Minutes (Summary) — GLPI103-301
• Pharmacy / IMP Manual — GLPI103-301
• Central Laboratory Manual — GLPI103-301
• Clinical Trial Agreement (CTA) & IRB/IEC Approval Tracker — GLPI103-301