# Preregistration scaffold: {{PROJECT_ID}}

> **UNREGISTERED DRAFT — NOT AN APPROVAL OR SCIENTIFIC ENDORSEMENT**
>
> Generated locally on {{GENERATED_ON}} from a validated structural record. Complete repository-specific fields, obtain required human/ethics/safety/regulatory review, and verify every statement before registration.

## 1. Administrative record

- Project ID: {{PROJECT_ID}}
- Accountable human owner: {{HUMAN_OWNER}}
- Record status: {{RECORD_STATUS}}
- Record updated: {{UPDATED_ON}}
- Registration repository and identifier: [TO COMPLETE]
- Registration timestamp: [TO COMPLETE]
- Study status and prior access to target data: [TO COMPLETE]
- Roles, funding, conflicts, sponsor role: [TO COMPLETE]

## 2. Authorization and oversight gates

{{ETHICS_AND_FEASIBILITY}}

- Human/animal/biosafety/dual-use/data/regulatory determinations and identifiers: [TO COMPLETE]
- Local policy and jurisdiction checked on: [TO COMPLETE]
- Unresolved work must not begin until the responsible authority clears it.

## 3. Search boundary and evidence

{{EVIDENCE_BOUNDARY}}

- Attach the completed search-boundary record and evidence ledger.
- “Not located within this boundary” does not establish universal absence or novelty.
- Verify every citation and claim-to-source link against the primary source.

## 4. Frozen observation

{{OBSERVATION}}

- Units, preprocessing, exclusions, missingness, and uncertainty: [TO COMPLETE]
- Whether expected or selected after inspection: [TO COMPLETE]

## 5. Research question and claim type

{{RESEARCH_QUESTION}}

## 6. Candidate hypotheses and mechanisms

{{HYPOTHESES}}

All listed hypotheses remain candidates. This scaffold does not rank or select one.

## 7. Causal estimand(s), if applicable

{{ESTIMANDS}}

- Target-trial/design analogue and identification logic: [TO COMPLETE]
- Confounding, selection, collider, measurement, reverse-causation, positivity, and interference assumptions: [TO COMPLETE]

## 8. Predictions, rivals, and falsification

{{PREDICTIONS}}

- Indeterminate and mixed-mechanism outcomes: [TO COMPLETE]
- Assumption/manipulation checks required before interpreting a challenge: [TO COMPLETE]

## 9. Null hypotheses and controls

{{NULLS_AND_CONTROLS}}

- Positive/procedural-control details: [TO COMPLETE]
- Why each negative control cannot operate through the target mechanism and which bias pathways it shares: [TO COMPLETE]

## 10. Operationalization and measurement validity

{{OPERATIONALIZATIONS}}

- Validity applicability, reliability/repeatability, calibration, detection limits, masking, missingness, invariance/comparability, and limitations: [TO COMPLETE]

## 11. Design

- Target population/system and sampling frame: [TO COMPLETE]
- Experimental/observational unit and analysis unit: [TO COMPLETE]
- Eligibility, recruitment/selection, and exclusions: [TO COMPLETE]
- Intervention/exposure and comparator versions: [TO COMPLETE]
- Allocation, randomization, concealment, and masking: [TO COMPLETE]
- Measurement schedule and quality control: [TO COMPLETE]
- Sample-size, precision, or information rationale with sensitivity to assumptions: [TO COMPLETE]
- Stopping, attrition, and missing-outcome plan: [TO COMPLETE]
- Replication, transport, and external-validation plan: [TO COMPLETE]

## 12. Analysis plan

{{ANALYSES}}

- Software, environment, versions, and seeds where applicable: [TO COMPLETE]
- Assumption diagnostics and model checks: [TO COMPLETE]
- Full multiplicity family across hypotheses, outcomes, timepoints, subgroups, models, and looks: [TO COMPLETE]
- Confirmatory versus exploratory outputs: [TO COMPLETE]

## 13. Data, code, materials, and retention

- Provenance and versioning: [TO COMPLETE]
- Data/code/material availability or justified restriction: [TO COMPLETE]
- Consent, privacy, community governance, intellectual property, export-control, biosafety, and dual-use limits: [TO COMPLETE]
- Approved storage, access, retention, and deletion: [TO COMPLETE]

## 14. AI and tool assistance

{{AI_USE}}

- Named tools/versions and material influence: [TO COMPLETE IF PERMITTED]
- Verification and disclosure plan: [TO COMPLETE]
- Sensitive or unpublished information must remain local unless explicitly authorized for a named service and scope.

## 15. Deviations and amendments

{{DEVIATION_PLAN}}

For each deviation record:

- date;
- affected section and IDs;
- original plan;
- change and rationale;
- decision owner;
- whether target results were known;
- expected interpretive impact;
- whether the original analysis will still be reported.

## 16. Human sign-off

- Domain expert: [NAME / DATE / STATUS]
- Measurement expert: [NAME / DATE / STATUS]
- Methodologist/statistician: [NAME / DATE / STATUS]
- Ethics/safety/data/regulatory authorities as applicable: [NAME / DATE / STATUS]
- Accountable investigator: [NAME / DATE / STATUS]

No signature turns a hypothesis into fact. Interpret results with uncertainty, rivals, boundary conditions, controls, and replication evidence.