compliance/preregistration.rs - Study Pre-registration System Abstract

High-Level Purpose

Comprehensive study pre-registration system that enforces scientific transparency by requiring researchers to specify hypotheses, analysis plans, and decision criteria before data collection, with integrity verification and deviation tracking.

Key Data Structures and Relationships

  • PreRegistration: Immutable study registration with cryptographic integrity verification
  • Hypothesis Framework: Structured primary/secondary hypothesis specification with effect predictions
  • Analysis Plan: Detailed statistical analysis specification with robustness checks and power analysis
  • Data Collection Protocol: Comprehensive sampling and data quality procedures with stopping rules
  • Validation System: Real-time analysis validation against pre-registered plans

Main Data Flows

  • Registration Creation: Structured study specification with validation and completeness checking
  • Integrity Verification: Cryptographic hashing for tamper-evident registration records
  • Analysis Validation: Runtime verification that analyses match pre-registered specifications
  • Deviation Tracking: Systematic documentation of any deviations from original plans
  • Transparency Reporting: Automated generation of transparency reports for publication

External Dependencies

  • serde: Serialization for registration persistence and export
  • chrono: Timestamp management for registration and deviation tracking
  • sha2: Cryptographic hashing for integrity verification
  • statrs: Statistical functions for power analysis and sample size calculation

State Management Patterns

  • Registration Lifecycle: Formal state transitions from Draft → Registered → Analysis Complete
  • Immutable Records: Tamper-evident registration with cryptographic verification
  • Deviation Log: Append-only tracking of any deviations with justification and impact assessment
  • Validation State: Runtime tracking of analysis compliance with pre-registered plans

Core Algorithms and Business Logic Abstractions

  • Integrity Verification: SHA-256 hashing for registration integrity and tamper detection
  • Analysis Matching: Variable and method matching between planned and executed analyses
  • Power Calculation: Statistical power analysis with automatic sample size determination
  • Transparency Scoring: Comprehensive transparency metrics for research quality assessment
  • Deviation Analysis: Impact assessment and categorization of protocol deviations

Scientific Integrity Features

  • Pre-commitment: Binding commitment to analysis plans before seeing data
  • Hypothesis Registration: Clear distinction between confirmatory and exploratory analyses
  • Multiple Comparison Control: Built-in correction for multiple testing with pre-specified methods
  • Effect Size Prediction: Quantitative effect size predictions with confidence intervals
  • Stopping Rules: Pre-specified criteria for study termination and sample size adjustment

Research Quality Assurance

  • Complete Documentation: Comprehensive study documentation with methodological details
  • Reproducible Analysis: Exact specification of all analytical procedures and assumptions
  • Bias Prevention: Systematic prevention of HARKing (Hypothesizing After Results are Known)
  • Transparency Enhancement: Public documentation of research plans and modifications
  • Quality Metrics: Automated calculation of study quality and transparency indicators