Metadata / approvals
Metadata
Approvals
Every text block’s tier, version and sign-off
Approvals
Every text block's frontmatter carries its tier, its version and its approval — who, and when. A generated block stays out of the report until that approval exists; the assembler's gate enforces it.
33text blocksboilerplate, parameterized, generated
10approvedby name and date in the frontmatter
23drafta lifecycle state, not a failure
5generated blocks held outuntil a person approves them
| Block | Title | Tier | State | By | At | Drafted by |
|---|---|---|---|---|---|---|
| TXT-SYN-0101 | Name of Sponsor, Finished Product and Active Ingredient §1.1 | boilerplate | draft | — | — | — |
| TXT-SYN-0102 | Title of Study §1.2 | boilerplate | draft | — | — | — |
| TXT-SYN-0103 | Investigators and Study Centres §1.3 | boilerplate | draft | — | — | — |
| TXT-SYN-0104 | Publication (Reference) §1.4 | boilerplate | draft | — | — | — |
| TXT-SYN-0105 | Studied Period §1.5 | boilerplate | draft | — | — | — |
| TXT-SYN-0106 | Phase of Development §1.6 | boilerplate | draft | — | — | — |
| TXT-SYN-1000 | Statistical Methods §10 | boilerplate | draft | — | — | — |
| TXT-E3-1001 | Disposition of Patients §10.1 | parameterized | approved | @jwildfire | 2026-07-25 | — |
| TXT-E3-1002 | Disposition of Patients: Summary of Named Values §10.1 | generated | draft | — | — | claude-opus-5 |
| TXT-E3-1101 | Data Sets Analysed §11.1 | parameterized | approved | @jwildfire | 2026-09-02 | — |
| TXT-E3-1102 | Demographic and Other Baseline Characteristics §11.2 | parameterized | approved | @jwildfire | 2026-07-25 | — |
| TXT-SYN-1102 | Safety Results §11.2 | parameterized | draft | — | — | — |
| TXT-SYN-1103 | Conclusion §11.3 | boilerplate | draft | — | — | — |
| TXT-SYN-1200 | Date of the Report §12 | boilerplate | draft | — | — | — |
| TXT-E3-1201 | Extent of Exposure §12.1 | parameterized | approved | @jwildfire | 2026-07-25 | — |
| TXT-E3-1221 | Brief Summary of Adverse Events §12.2.1 | parameterized | approved | @jwildfire | 2026-07-25 | — |
| TXT-E3-1222 | Display of Adverse Events §12.2.2 | generated | draft | — | — | claude-opus-5 |
| TXT-E3-1224 | Listing of Adverse Events by Patient §12.2.4 | boilerplate | approved | @jwildfire | 2026-07-25 | — |
| TXT-E3-1231 | Listing of Deaths, Other Serious Adverse Events and Other Significant Adverse Events §12.3.1 | generated | draft | — | — | claude-opus-5 |
| TXT-E3-1206 | Safety Conclusions §12.6 | generated | draft | — | — | claude-opus-5 |
| TXT-E3-1300 | Discussion and Overall Conclusions §13 | generated | draft | — | — | claude-opus-5 |
| TXT-SYN-0200 | Objectives §2 | boilerplate | draft | — | — | — |
| TXT-SYN-0300 | Methodology §3 | boilerplate | draft | — | — | — |
| TXT-SYN-0400 | Number of Patients (Planned and Analysed) §4 | parameterized | draft | — | — | — |
| TXT-SYN-0500 | Diagnosis and Main Criteria for Inclusion §5 | boilerplate | draft | — | — | — |
| TXT-E3-0502 | Ethical Conduct of the Study §5.2 | boilerplate | approved | @jwildfire | 2026-07-25 | — |
| TXT-E3-0503 | Patient Information and Consent §5.3 | boilerplate | approved | @jwildfire | 2026-07-25 | — |
| TXT-SYN-0600 | Test Product, Dose and Mode of Administration, Batch Number §6 | boilerplate | draft | — | — | — |
| TXT-SYN-0700 | Duration of Treatment §7 | parameterized | draft | — | — | — |
| TXT-SYN-0800 | Reference Therapy, Dose and Mode of Administration, Batch Number §8 | boilerplate | draft | — | — | — |
| TXT-E3-0901 | Overall Study Design and Plan: Description §9.1 | parameterized | approved | @jwildfire | 2026-07-25 | — |
| TXT-SYN-0902 | Criteria for Evaluation: Safety §9.2 | boilerplate | draft | — | — | — |
| TXT-E3-0908 | Changes in the Conduct of the Study or Planned Analyses §9.8 | boilerplate | approved | @jwildfire | 2026-07-25 | — |