Report Template Library
Post-Text Display Package 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/display-package/sections.yaml encodes this document's 11-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 16.1.9 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 14.1.1 | Subject Disposition | t-disposition | 14.1 |
| Table 14.1.2 | Demographic and Baseline Characteristics | t-demographics | 14.1 |
| Table 14.3.1.1 | Extent of Exposure to Study Drug | t-exposure | 14.3.1 |
| Table 14.3.1.2 | Overview of Treatment-Emergent Adverse Events | t-ae-overview | 14.3.1 |
| Table 14.3.1.3 | Treatment-Emergent Adverse Events by System Organ Class and Preferred Term | t-ae-common | 14.3.1 |
| Listing 14.3.2.1 | Listing of Serious Adverse Events | l-ae-serious | 14.3.2 |
| Table 14.3.5.1 | Summary of Vital Signs at Baseline and End of Treatment | t-vitals | 14.3.5 |
| Table 14.3.5.2 | Summary of Vital Signs Change from Baseline at End of Treatment | t-vitals-change | 14.3.5 |
| Table 14.3.5.3 | Summary of Weight and Weight Change from Baseline at End of Treatment | t-weight | 14.3.5 |
| Table 14.3.5.4 | Summary of Concomitant Medications | t-conmeds | 14.3.5 |
The document skeleton
All 11 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 |
|---|---|---|---|---|---|
| 14 | Tables, Figures and Graphs Referred to but not Included in the Text | post text index | — | — | not in this demo |
| 14.1 | Demographic Data | post text index | — | Table 14.1.1 Table 14.1.2 | populated |
| 14.2 | Efficacy Data | post text index | — | — | not in this demo |
| 14.3 | Safety Data | — | — | — | not in this demo |
| 14.3.1 | Displays of Adverse Events | post text index | — | Table 14.3.1.1 Table 14.3.1.2 Table 14.3.1.3 | populated |
| 14.3.2 | Listings of Deaths, Other Serious and Significant Adverse Events | post text index | — | Listing 14.3.2.1 | populated |
| 14.3.4 | Abnormal Laboratory Value Listing (Each Patient) | post text index | — | — | not in this demo |
| 14.3.5 | Displays of Vital Signs, Weight and Concomitant Medications | post text index | — | Table 14.3.5.1 Table 14.3.5.2 Table 14.3.5.3 Table 14.3.5.4 | populated |
| 16 | Appendices | — | — | — | not in this demo |
| 16.1 | Study Information | — | — | — | not in this demo |
| 16.1.9 | Documentation of Statistical Methods | text generated provenance | — | — | not in this demo |