Evidence and reconstruction method
Evidence hierarchy
Section titled “Evidence hierarchy”- Current official product help for observable objects, actions, states and integrations.
- Official product pages and feature briefs for product boundary and practitioner language.
- ICH, CDISC and TMF reference materials for clinical and regulatory semantics.
- Product-manager scenarios for edge cases and configuration-dependent behaviour.
Marketing claims are never used to infer an invariant. A UI label is not promoted to an object unless it has identity, lifecycle, relationships, rules, or independent use in scenarios.
Reconstruction record
Section titled “Reconstruction record”Every vertical documents four layers:
| Layer | Question |
|---|---|
| Observed vocabulary | What objects and actions are consistently present in mature clinical products? |
| Product boundary | What responsibility does the vertical appear to own? |
| TechSol decision | What storage-independent object, value, policy or outcome do we propose? |
| Difference / question | Where do we deliberately diverge or lack enough evidence? |
Verification standard
Section titled “Verification standard”An object is not accepted merely because an established product has a record with that label. It must pass:
- at least two concrete workflows;
- correction/version behaviour;
- a negative or refusal scenario;
- ownership analysis across connected products;
- terminology and identity review;
- at least one lifecycle edge case.
Research status
Section titled “Research status”| Vertical | Principal product evidence | Current state |
|---|---|---|
| Platform | objects, documents, lifecycles, workflows, audit/security | Reconstructed v0.1 |
| CTMS | official CTMS overview and monitoring/metrics help | Reconstructed v0.1 |
| eTMF | EDLs, TMF homepage, document matching, quality issues | Reconstructed v0.1 |
| Study Startup | official overview, feasibility, milestones and activation | Reconstructed v0.1 |
| Payments | official Payments overview and fee/payable-item behaviour | Reconstructed v0.1 |
| Site Collaboration | document distribution, requests and reconciliation behaviour | Reconstructed v0.1 |
| Study Training | Clinical Operations connection and product evidence | Reconstructed v0.1 |
| Disclosures | product boundary evidence | Reconstructed v0.1; deeper lifecycle research required |
| Site & Investigator Intelligence | curated party and affiliation behaviour | Reconstructed v0.1 |
| EDC | Studio, Casebooks, rules, review, queries, signatures, amendments, locks | Reference-quality candidate v0.2 |
| Clinical Data Quality | multisource workbench, check and connector behaviour | Reconstructed v0.1 |
| RTSM | official product and feature briefs | Reconstructed v0.1 |
| eCOA | official product and feature briefs | Reconstructed v0.1 |