open.csr Versioned numbers, versioned words, one traceable loop.

Report Template Library

Clinical Study Report 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/ich-e3/sections.yaml encodes this document's 120-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.

120sections modelledthe whole skeleton, filled or not
21populated in this demoevery other section renders as a marked gap
30displays numberedassigned at assembly, not authored
16assembly slots configuredtext blocks and in-text displays

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.

NumberDisplaySlugSection
Table 14.1.1Subject Dispositiont-disposition14.1
Table 14.1.2Demographic and Baseline Characteristicst-demographics14.1
Table 14.1.3Summary of Populationst-populations14.1
Table 14.1.4Summary of End of Study Datat-end-of-study14.1
Table 14.1.5Summary of Number of Subjects By Sitet-subjects-by-site14.1
Figure 14.1.6Subject Dispositionf-disposition14.1
Table 14.2.1Primary Endpoint Analysis: ADAS-Cog (11) - Change from Baseline to Week 24 - LOCFt-eff-adas-wk2414.2
Table 14.2.2Primary Endpoint Analysis: CIBIC+ — Summary at Week 24 — LOCFt-cibic-week2414.2
Table 14.2.3ADAS-Cog (11) - Change from Baseline to Week 8 - LOCFt-eff-adas-wk814.2
Table 14.2.4CIBIC+ — Summary at Week 8 — LOCFt-cibic-week814.2
Table 14.2.5ADAS-Cog (11) - Change from Baseline to Week 16 - LOCFt-eff-adas-wk1614.2
Table 14.2.6CIBIC+ — Summary at Week 16 — LOCFt-cibic-week1614.2
Table 14.2.7ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowedt-eff-adas-wk24-completers14.2
Table 14.2.8ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCFt-eff-adas-wk24-male14.2
Table 14.2.9ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCFt-eff-adas-wk24-female14.2
Table 14.2.10ADAS-Cog (11) - Mean and Mean Change from Baseline over Timet-eff-adas-overtime14.2
Table 14.2.11ADAS-Cog (11) - Repeated Measures Analysis of Change from Baseline to Week 24t-eff-adas-mmrm14.2
Table 14.2.12Mean NPI-X Total Score from Week 4 through Week 24 - Windowedt-eff-npix-mean14.2
Table 14.2.13CIBIC+ — Categorical Analysis — LOCFt-cibic-categorical14.2
Figure 14.2.14Time to Dermatologic Event by Treatment Groupf-derm-time-to-event14.2
Table 14.3.1.1Extent of Exposure to Study Drugt-exposure14.3.1
Table 14.3.1.2Overview of Treatment-Emergent Adverse Eventst-ae-overview14.3.1
Table 14.3.1.3Treatment-Emergent Adverse Events by System Organ Class and Preferred Termt-ae-common14.3.1
Table 14.3.1.4Incidence of Treatment Emergent Adverse Events by Treatment Groupt-ae-incidence14.3.1
Listing 14.3.2.1Listing of Serious Adverse Eventsl-ae-serious14.3.2
Table 14.3.2.2Incidence of Treatment Emergent Serious Adverse Events by Treatment Groupt-sae-incidence14.3.2
Table 14.3.5.1Summary of Vital Signs at Baseline and End of Treatmentt-vitals14.3.5
Table 14.3.5.2Summary of Vital Signs Change from Baseline at End of Treatmentt-vitals-change14.3.5
Table 14.3.5.3Summary of Weight and Weight Change from Baseline at End of Treatmentt-weight14.3.5
Table 14.3.5.4Summary of Concomitant Medicationst-conmeds14.3.5

The document skeleton

All 120 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.

§TitleContent modelTextDisplaysState
1Title Pagetext——not in this demo
2Synopsistext——not in this demo
3Table of Contents for the Individual Clinical Study Report———not in this demo
4List of Abbreviations and Definition of Termstext——not in this demo
5Ethics———not in this demo
5.1Independent Ethics Committee (IEC) or Institutional Review Board (IRB)text——not in this demo
5.2Ethical Conduct of the StudytextTXT-E3-0502—populated
5.3Patient Information and ConsenttextTXT-E3-0503—populated
6Investigators and Study Administrative Structuretext——not in this demo
7Introductiontext——not in this demo
8Study Objectivestext——not in this demo
9Investigational Plan———not in this demo
9.1Overall Study Design and Plan: Descriptiontext in text displayTXT-E3-0901—populated
9.2Discussion of Study Design, Including the Choice of Control Groupstext——not in this demo
9.3Selection of Study Population———not in this demo
9.3.1Inclusion Criteriatext——not in this demo
9.3.2Exclusion Criteriatext——not in this demo
9.3.3Removal of Patients from Therapy or Assessmenttext——not in this demo
9.4Treatments———not in this demo
9.4.1Treatments Administeredtext——not in this demo
9.4.2Identity of Investigational Product(s)text——not in this demo
9.4.3Method of Assigning Patients to Treatment Groupstext——not in this demo
9.4.4Selection of Doses in the Studytext——not in this demo
9.4.5Selection and Timing of Dose for Each Patienttext——not in this demo
9.4.6Blindingtext——not in this demo
9.4.7Prior and Concomitant Therapytext in text display——not in this demo
9.4.8Treatment Compliancetext in text display——not in this demo
9.5Efficacy and Safety Variables———not in this demo
9.5.1Efficacy and Safety Measurements Assessed and Flow Charttext in text display——not in this demo
9.5.2Appropriateness of Measurementstext——not in this demo
9.5.3Primary Efficacy Variable(s)text——not in this demo
9.5.4Drug Concentration Measurementstext——not in this demo
9.6Data Quality Assurancetext——not in this demo
9.7Statistical Methods Planned in the Protocol and Determination of Sample Size———not in this demo
9.7.1Statistical and Analytical Planstext——not in this demo
9.7.2Determination of Sample Sizetext——not in this demo
9.8Changes in the Conduct of the Study or Planned AnalysestextTXT-E3-0908—populated
10Study Patients———not in this demo
10.1Disposition of Patientstext in text displayTXT-E3-1001 TXT-E3-1002Table 14.1.1 Figure 14.1.6populated
10.2Protocol Deviationstext in text display——not in this demo
11Efficacy Evaluation———not in this demo
11.1Data Sets Analysedtext in text displayTXT-E3-1101—populated
11.2Demographic and Other Baseline Characteristicstext in text displayTXT-E3-1102Table 14.1.2populated
11.3Measurements of Treatment Compliancetext in text display——not in this demo
11.4Efficacy Results and Tabulations of Individual Patient Data———not in this demo
11.4.1Analysis of Efficacytext in text display——not in this demo
11.4.2Statistical/Analytical Issues———not in this demo
11.4.2.1Adjustments for Covariatestext——not in this demo
11.4.2.2Handling of Dropouts or Missing Datatext——not in this demo
11.4.2.3Interim Analyses and Data Monitoringtext——not in this demo
11.4.2.4Multicentre Studiestext——not in this demo
11.4.2.5Multiple Comparison/Multiplicitytext——not in this demo
11.4.2.6Use of an "Efficacy Subset" of Patientstext——not in this demo
11.4.2.7Active-Control Studies Intended to Show Equivalencetext——not in this demo
11.4.2.8Examination of Subgroupstext in text display——not in this demo
11.4.3Tabulation of Individual Response Datatext——not in this demo
11.4.4Drug Dose, Drug Concentration, and Relationships to Responsetext in text display——not in this demo
11.4.5Drug-Drug and Drug-Disease Interactionstext——not in this demo
11.4.6By-Patient Displaystext——not in this demo
11.4.7Efficacy Conclusionstext——not in this demo
12Safety Evaluation———not in this demo
12.1Extent of Exposuretext in text displayTXT-E3-1201Table 14.3.1.1populated
12.2Adverse Events (AEs)———not in this demo
12.2.1Brief Summary of Adverse Eventstext in text displayTXT-E3-1221Table 14.3.1.2populated
12.2.2Display of Adverse Eventstext in text displayTXT-E3-1222Table 14.3.1.3populated
12.2.3Analysis of Adverse Eventstext in text display—Table 14.3.1.4populated
12.2.4Listing of Adverse Events by PatienttextTXT-E3-1224—populated
12.3Deaths, Other Serious Adverse Events, and Other Significant Adverse Events———not in this demo
12.3.1Listing of Deaths, Other Serious Adverse Events and Other Significant Adverse Eventstext in text displayTXT-E3-1231Listing 14.3.2.1populated
12.3.1.1Deathstext——not in this demo
12.3.1.2Other Serious Adverse Eventstext——not in this demo
12.3.1.3Other Significant Adverse Eventstext——not in this demo
12.3.2Narratives of Deaths, Other Serious and Certain Other Significant Adverse Eventstext——not in this demo
12.3.3Analysis and Discussion of Deaths, Other Serious and Other Significant Adverse Eventstext——not in this demo
12.4Clinical Laboratory Evaluation———not in this demo
12.4.1Listing of Individual Laboratory Measurements by Patient and Each Abnormal Laboratory Valuetext——not in this demo
12.4.2Evaluation of Each Laboratory Parameter———not in this demo
12.4.2.1Laboratory Values Over Timetext in text display——not in this demo
12.4.2.2Individual Patient Changestext in text display——not in this demo
12.4.2.3Individual Clinically Significant Abnormalitiestext——not in this demo
12.5Vital Signs, Physical Findings and Other Observations Related to Safetytext in text display—Table 14.3.5.3populated
12.6Safety ConclusionstextTXT-E3-1206—populated
13Discussion and Overall ConclusionstextTXT-E3-1300—populated
14Tables, Figures and Graphs Referred to but not Included in the Textpost text index——not in this demo
14.1Demographic Datapost text index—Table 14.1.1 Table 14.1.2 Table 14.1.3 Table 14.1.4 Table 14.1.5 Figure 14.1.6populated
14.2Efficacy Datapost text index—Table 14.2.1 Table 14.2.2 Table 14.2.3 Table 14.2.4 Table 14.2.5 Table 14.2.6 Table 14.2.7 Table 14.2.8 Table 14.2.9 Table 14.2.10 Table 14.2.11 Table 14.2.12 Table 14.2.13 Figure 14.2.14populated
14.3Safety Data———not in this demo
14.3.1Displays of Adverse Eventspost text index—Table 14.3.1.1 Table 14.3.1.2 Table 14.3.1.3 Table 14.3.1.4populated
14.3.2Listings of Deaths, Other Serious and Significant Adverse Eventspost text index—Listing 14.3.2.1 Table 14.3.2.2populated
14.3.3Narratives of Deaths, Other Serious and Certain Other Significant Adverse Eventstext——not in this demo
14.3.4Abnormal Laboratory Value Listing (Each Patient)post text index——not in this demo
14.3.5Displays of Vital Signs, Weight and Concomitant Medicationspost text index—Table 14.3.5.1 Table 14.3.5.2 Table 14.3.5.3 Table 14.3.5.4populated
15Reference Listtext——not in this demo
16Appendices———not in this demo
16.1Study Information———not in this demo
16.1.1Protocol and Protocol Amendmentstext——not in this demo
16.1.2Sample Case Report Form (unique pages only)text——not in this demo
16.1.3List of IEC or IRB and Representative Written Information for Patient and Sample Consent Formstext——not in this demo
16.1.4List and Description of Investigators and Other Important Participants in the Study, Including Brief CVs or Equivalent Summaries of Training and Experiencetext——not in this demo
16.1.5Signatures of Principal or Coordinating Investigator(s) or Sponsor's Responsible Medical Officertext——not in this demo
16.1.6Listing of Patients Receiving Test Drug(s)/Investigational Product(s) from Specific Batches, Where More Than One Batch Was Usedtext——not in this demo
16.1.7Randomisation Scheme and Codes (patient identification and treatment assigned)text——not in this demo
16.1.8Audit Certificates (if available)text——not in this demo
16.1.9Documentation of Statistical Methodstext generated provenance——not in this demo
16.1.10Documentation of Inter-laboratory Standardisation Methods and Quality Assurance Procedures if Usedtext——not in this demo
16.1.11Publications Based on the Studytext——not in this demo
16.1.12Important Publications Referenced in the Reporttext——not in this demo
16.2Patient Data Listings———not in this demo
16.2.1Discontinued Patientspost text index——not in this demo
16.2.2Protocol Deviationspost text index——not in this demo
16.2.3Patients Excluded from the Efficacy Analysispost text index——not in this demo
16.2.4Demographic Datapost text index——not in this demo
16.2.5Compliance and/or Drug Concentration Data (if available)post text index——not in this demo
16.2.6Individual Efficacy Response Datapost text index——not in this demo
16.2.7Adverse Event Listings (each patient)post text index——not in this demo
16.2.8Listing of Individual Laboratory Measurements by Patient, When Required by Regulatory Authoritiespost text index——not in this demo
16.3Case Report Forms———not in this demo
16.3.1CRFs for Deaths, Other Serious Adverse Events and Withdrawals for AEtext——not in this demo
16.3.2Other CRFs Submittedtext——not in this demo
16.4Individual Patient Data Listings (US Archival Listings)post text index——not in this demo