Changes in version 0.1.2 (2026-07-21) CRAN resubmission addressing a second review comment; no functional changes. - DESCRIPTION: write the HARPER and RECORD-PE framework names in normal capitalization ("Harmonized...", "Reporting...", "Pharmacoepidemiology") instead of the mixed-case styling that the CRAN spell check flagged. The acronyms remain in parentheses. Changes in version 0.1.1 CRAN resubmission addressing reviewer feedback; no functional changes. - DESCRIPTION: all acronyms (OMOP, CDM, RWE, HTML, JSON, FDA, HARPER, RECORD-PE) are now explained at first use, and references follow the authors (year) format. - Removed the \dontrun{} example from validate_cohort(); the live-database call is now shown in the function's Details section. - Added an executable example to cdm_disconnect(). The only remaining \dontrun{} example is cdm_connect(), which requires a live PostgreSQL server and credentials. - Expanded the Title to spell out "OMOP Common Data Model". - example_cdm() now builds a 20-person, two-arm demo CDM (target and comparator), so every exported module — including run_covariates() — has a runnable example against the bundled database. - Added @examples to run_attrition(), run_density(), run_concepts(), and run_covariates(). Changes in version 0.1.0 First public release. rwevalidate validates an instantiated OMOP CDM cohort for real-world-evidence use and produces a regulator-aligned HTML + JSON report from a single validate_cohort() call. Features - cdm_connect() / cdm_disconnect() - open a PostgreSQL CDM connection and validate that the required clinical tables exist (split-schema aware). - Module 1 - run_concepts() - concept prevalence, ancestor coverage, and per-domain vocabulary mapping rate (FDA Relevance). - Module 2 - run_attrition() - cohort size, index-date distribution, prior-observation coverage, and demographics at index (HARPER / RECORD-PE). - Module 3 - run_density() - records per patient per month by domain and follow-up completeness with a censoring breakdown (FDA Reliability). - Module 4 - run_covariates() - standardized mean differences (love plot), per-arm prevalence, and a power calculation against a comparator (HARPER). - Reporting - render_validation_report() writes a self-contained HTML report with a traffic-light summary plus a machine-readable validation_results.json sidecar; write_results_json() works without Pandoc. - validate_cohort() - one entry point that wires connection, all modules, and the report. Accepts an open con or PostgreSQL connection arguments; concept_ids enables Module 1, comparator_id enables Module 4. Notes - Targets OMOP CDM v5.3.1. Validated against MIMIC-IV on PostgreSQL and a synthetic DuckDB mock used by the test suite. - No dependency on CohortDiagnostics, DataQualityDashboard, or Achilles. - All thresholds are documented, configurable function arguments.