Filing
Evidence-first classification; high confidence routes to a proposal, never a write.
Custody root is a routing axis alongside confidence.
Open in console →Enter the access password to open the reference applications.
Incorrect password.
The eTMF-intelligence capabilities are good and this bundle keeps almost all of them. What it changes is the substrate: records stay with the custodian who generated them, and intelligence reads across all of them. You do not migrate into a repository — you join a graph, and vendors compete on how well they read it.
One repository was the only implementable answer — until the guideline is read as plural custody.
The prior art assumes the eTMF is the system of record and intelligence sits on top. That was correct when a single container was the only substrate. ICH E6(R3) C.2.3–C.2.4 and C.2.7 describe plural repositories, locators, and originals with the party who generated them — the TMF is a view, not a building.
Everything above is argued as an offering; everything below is what the bundle actually encodes against ICH E6(R3) on a participant-anchored graph.
The graph holds locators and relations; bodies stay with custodians. Seven custody roots — participant, site, sponsor, IRB, manufacturer, shared, commons — appear throughout the reference console so plural custody is visible, not inferred.
Bundle depth: ruby tools/validate_tsdg.rb ·
offering section on layers & boundary
Each view re-expresses a familiar eTMF-intelligence screen over the graph. They are wired together in the console: start at Readiness (it refuses when a custodian has not answered), then follow how that refusal propagates.
Evidence-first classification; high confidence routes to a proposal, never a write.
Custody root is a routing axis alongside confidence.
Open in console →Expected records derived from the study’s own records, not only a template list.
Locator index coverage is the honest denominator.
Open in console →Catalogue of checks with candidate and agreed states; findings are proposals.
A custodian spends a grant to act on a finding.
Open in console →Discrepancies live between two custodians’ valid records.
A single system of record cannot form this finding.
Open in console →Weighted composite with visible weights — and a refusal when input is missing.
Not a degraded score: the unanswered custodian is named.
Open in console →Vendor conformance and published rejection rates per check.
A high rejection rate is a signal, not a secret.
Open in console →
Open the full TSDG console tour →
· synthetic study COMMONS-STUDY-001, six custodians, two initially unresponsive
Same graph, different trade-offs — spelled out in the long-form offering page.
One read surface, cross-custodian findings, public rejection rates — in exchange for giving up the write and the lock-in.
For a vendor →Better completeness and inspection locators; slower correction; you lose the single confident number when custodians have not answered.
For a sponsor or CRO →Custody root at the person: trial evidence referred from the sponsor’s view, not copied into it by default.
For participants →Capability surface substantially from IntuitionLabs’ published design — re-expressed here with no code reuse. Veeva names are descriptive, not endorsement.
Credit & trademarks →H-CTM0a/b are structurally checked; H-CTM1–5 need a trial. The console shows shape, not confirmation.
Falsifiers & status →