Report Template Library
Study Synopsis as data
ICH E3 has been unrevised since 1995 and no machine-readable model of it existed publicly; ICH M11 did this for protocols in November 2025. library/templates/e3-synopsis/sections.yaml encodes this document's 25-entry skeleton — number, title, slug and content model. assembly.yaml says what this report puts in it. Display numbers appear in neither: the assembler derives them from assembly order, so reordering the report is a one-line diff and a display's identity never changes (design D6). The library is plural — the same two files describe every document open.csr assembles.
Section 14 is generated, not written: package versions, ARD hashes, data manifests and session info are emitted mechanically. E3 reserved that slot in 1995 and open.csr fills it from the build.
Assigned numbering
Derived from assembly.yaml post_text order at build time. The slug is what the specs, the ARDs and the bindings all refer to — reorder the report and every number here moves while no spec, ARD or sentence changes at all.
| Number | Display | Slug | Section |
|---|---|---|---|
| Table 13.1 | Subject Disposition | t-disposition | 13 |
| Table 13.2 | Demographic and Baseline Characteristics | t-demographics | 13 |
| Table 13.3 | Extent of Exposure to Study Drug | t-exposure | 13 |
| Table 13.4 | Overview of Treatment-Emergent Adverse Events | t-ae-overview | 13 |
| Table 13.5 | Treatment-Emergent Adverse Events by System Organ Class and Preferred Term | t-ae-common | 13 |
| Listing 13.6 | Listing of Serious Adverse Events | l-ae-serious | 13 |
The document skeleton
All 25 modelled sections, and what this report puts in each. Sections marked not in this demo still assemble, as headings that say so — the skeleton stays visible rather than being trimmed to what happens to be built.
| § | Title | Content model | Text | Displays | State |
|---|---|---|---|---|---|
| 1 | Administrative Information | — | — | — | not in this demo |
| 1.1 | Name of Sponsor, Finished Product and Active Ingredient | text | TXT-SYN-0101 | — | populated |
| 1.2 | Title of Study | text | TXT-SYN-0102 | — | populated |
| 1.3 | Investigators and Study Centres | text | TXT-SYN-0103 | — | populated |
| 1.4 | Publication (Reference) | text | TXT-SYN-0104 | — | populated |
| 1.5 | Studied Period | text | TXT-SYN-0105 | — | populated |
| 1.6 | Phase of Development | text | TXT-SYN-0106 | — | populated |
| 2 | Objectives | text | TXT-SYN-0200 | — | populated |
| 3 | Methodology | text | TXT-SYN-0300 | — | populated |
| 4 | Number of Patients (Planned and Analysed) | text in text display | TXT-SYN-0400 | Table 13.1 | populated |
| 5 | Diagnosis and Main Criteria for Inclusion | text | TXT-SYN-0500 | — | populated |
| 6 | Test Product, Dose and Mode of Administration, Batch Number | text | TXT-SYN-0600 | — | populated |
| 7 | Duration of Treatment | text in text display | TXT-SYN-0700 | Table 13.3 | populated |
| 8 | Reference Therapy, Dose and Mode of Administration, Batch Number | text | TXT-SYN-0800 | — | populated |
| 9 | Criteria for Evaluation | — | — | — | not in this demo |
| 9.1 | Efficacy | text | — | — | not in this demo |
| 9.2 | Safety | text | TXT-SYN-0902 | — | populated |
| 10 | Statistical Methods | text | TXT-SYN-1000 | — | populated |
| 11 | Summary — Conclusions | — | — | — | not in this demo |
| 11.1 | Efficacy Results | text | — | — | not in this demo |
| 11.2 | Safety Results | text in text display | TXT-SYN-1102 | Table 13.4 | populated |
| 11.3 | Conclusion | text | TXT-SYN-1103 | — | populated |
| 12 | Date of the Report | text | TXT-SYN-1200 | — | populated |
| 13 | Supporting Displays | post text index | — | Table 13.1 Table 13.2 Table 13.3 Table 13.4 Table 13.5 Listing 13.6 | populated |
| 14 | Provenance of the Assembled Synopsis | generated provenance | — | — | not in this demo |