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.