v1.0.0-database-resourceSchema 1.1Model ridge-safe-v2.3Benchmark repeated-fold-v2.2Build EA-20260729-15v1.0 is a database and evidence-governance release; it is not a validated disease-prediction or clinical decision-support release.
Current selection: unresolved requires registration
State whether the disease-associated direction is hypothesized as causal, compensatory or accompanying, and preserve the opposite-direction alternative. DMD direction and counteralignment never choose an intervention automatically.
Allowed registered hypotheses: activation; inhibition; bidirectional exploration; direction not identifiable.
Comparator and controls
Non-targeting and mock controls.
Positive toxicity control.
Matched healthy/DMD or isogenic context.
Dose and time vehicle controls.
Secondary endpoints
Target engagement.
Functional muscle phenotype.
Off-target and tissue-breadth context.
State-transition extension
Mechanism hypothesis and registered time axis
Scientific object: perturbation × cell state × disease context × time × phenotype
Required before registration: state the proposed early molecular mediator, the expected cell-state transition and the downstream functional consequence.
6–12 hearly molecular or signalling response
planning default requires assay calibration
24–48 hregulatory program and cell-state transition
planning default requires assay calibration
4–7 ddifferentiation and functional phenotype
planning default requires assay calibration
Cell context fields
Required before registration: healthy, DMD or isogenic corrected. Required before registration: proliferating myoblast, early differentiation, fusion or maturing myotube. Required before registration; preserve donor-specific estimates.
Cell–cell consequence
Current status: not assessed. Future levels: conditioned medium; two-cell co-culture; three-dimensional muscle model; spatial perturbation model.
Blocking factors
Donor/isogenic pair.
Plate.
Dose/time batch.
Reagent.
Assay QC thresholds
Numeric viability floor.
Numeric target-engagement floor.
Predeclared off-target exclusion criteria.
Minimally important effect
Required before registration; derive from assay biology or a justified pilot and store the numeric value with units.
Negligible-effect margin
Required before interpreting a null result; store a symmetric or asymmetric numeric margin with units.
Multiplicity and missing data
Primary safety endpoint across frozen doses/times; functional endpoints are secondary.
Define exclusions before unblinding; report all missing units and reasons; do not single-impute primary outcomes without a prespecified sensitivity analysis.
Replication rules
Escalation requires directionally compatible safety estimates from two reagents.
A favourable window must not be attributable to one donor/context.
Stop rules
Stop or classify as infeasible if a required numeric QC threshold fails.
Do not interpret a nonsignificant result as no material effect without a negligible-effect interval.
Do not change canonical candidate status automatically; require governed review.
Time and cost6–12 weeks after model readiness; planning estimate only. Institution- and assay-dependent; obtain a local itemised quote before registration.
Preregistration statusdraft requires direction rationale numeric effect margin sample size and qc thresholds
Lifecycle ruleThis draft is editable. Registration requires a timestamp and checksum; a registered revision is immutable and any correction must supersede it.
Escalation ruleEscalate from L2 to L3b only after independent context-matched perturbation replication; L4 requires replicated DMD-relevant muscle evidence.
Evidence transitionCurrent evidence state → predeclared independent test → governed evidence-level review.
Data-release planRelease the frozen card, protocol identifiers, analysis code, complete denominators and results irrespective of direction; never overwrite the registered card.
Boundary: This Study Card is an evidence-gated design scaffold, not a protocol, power calculation, safety claim, prediction or therapeutic recommendation.