Protocol

Research Design & Pre‑Registration Protocol

An interactive pre-registration protocol form and template to design rigorous studies, specify analysis plans, record pre-specified outcomes, and capture an auditable changelog for deviations. Saves a machine-readable protocol you can update and attach to registries, repositories, or project records.

Interactive Tool

Research Design & Pre‑Registration Protocol

This interactive protocol helps teams pre-register study designs and analysis plans to reduce bias, prevent HARKing, and improve reproducibility. Use a clear, precise primary outcome and an explicit analysis plan. Save this protocol before data collection begins; update the version and record any deviations in the changelog with date and rationale. Where helpful, include links to code repositories, registry records (OSF, ClinicalTrials.gov, etc.), and data-sharing plans.

e.g., v1.0. Increment the version when you make planned changes.
Concise, descriptive title.
Why this study matters (2–4 sentences).
State the primary hypothesis you will test. Be specific and falsifiable.
List secondary or exploratory hypotheses, if any.
Specify the variable, measurement method, timing, units, and how it will be computed (for example, change from baseline at 12 weeks).
Define each secondary outcome with measurement and timing.
Choose the design that best fits your study.
Describe key design elements, timelines, and arms.
Specify target population, inclusion and exclusion criteria, and recruitment sources.
Total planned sample size and allocation per group if applicable.
Report assumptions, expected effect size, alpha, target power, and provide the calculation or link to the script used.
Describe method for generating allocation sequence, stratification factors, block size (if used), and allocation concealment procedures.
Who will be blinded? Choose the best option and add details if needed.
Detailed description of interventions, dosages, timing, equipment, comparison conditions, or how exposures are measured.
Describe instruments, forms, schedules, training, and quality control steps for data collection.
Specify statistical models, outcome definitions, covariates, transformations, estimation approach, hypothesis tests, and whether analysis is intention-to-treat or per-protocol.
Planned methods for missing data (e.g., complete-case, multiple imputation) and related sensitivity analyses.
List any pre-specified subgroup analyses or sensitivity checks and their rationales.
Include software names/versions and links to analysis scripts or repositories (e.g., GitHub, OSF).
Describe any planned interim looks, stopping criteria, and DSMB arrangements.
IRB/ethics committee reference numbers, approval dates, and consent procedures.
Where data will be stored, access controls, anonymization procedures, and planned data sharing (repository and timing).
Describe how protocol deviations will be recorded. Use this field to add an initial changelog entry; when updates occur, append a dated note with rationale and impact on analyses.
Link to OSF, ClinicalTrials.gov, or institutional pre-registration.
YYYY-MM-DD. Use today's date if registering now.
Name and role of the person who approves this pre-registration.
Type your name to attest that this pre-registration reflects planned analyses and design (not a legal signature).
Email for correspondence and project-specific notes.
Public intention supports transparency.
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