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coreval: Check Clinical Trial Data Against 'CDISC' Open Rules

Source: R/coreval-package.R
coreval-package.Rd

Finds conformance problems in clinical trial data without leaving R, using the openly published 'CDISC' Open Rules ('CORE'). Check a single dataset while you are still writing the code that builds it, or a whole study folder once it exists, and get the findings back as a tidy data frame pointing at the exact row and variable. Reads transport ('XPT'), 'SAS', comma-separated and 'Dataset-JSON' files, plus 'Define-XML' when present, and 'USDM' study-design documents. Covers rules for the 'SDTM', 'SEND', 'TIG' and 'USDM' standards. The rules are bundled inside the package, so nothing is downloaded and your data never leaves your machine: no internet, no API key, no account. When a rule cannot be checked - because it needs a dataset you did not supply, for instance - it is reported as skipped with the reason, never counted as a pass. Meant as a quick first pass before a qualified validation system, never as a replacement for one. An independent project: not affiliated with or endorsed by 'CDISC', and not a 'CORE'-certified conformance engine.

Details

coreval finds CDISC conformance problems in clinical trial data without leaving R. Run it early and often, while you are still writing the code that produces the data, so problems turn up while they are cheap to fix.

Two ways in, depending on what you have:

  • check_dataset() - one dataset, either a data frame you already have open or a single file. Use this while writing code.

  • read_study() then check_study() - a whole study folder. Use this once the datasets exist, since the cross-dataset rules need everything present.

Both entry points give you two tables, and both matter. $findings is what is wrong. $skipped is what could not be checked, with a reason for each. An empty $findings can mean clean data or rules that never ran, and those look identical if you only read the first table.

write_findings() saves both to Excel or CSV. vignette("coreval") walks through all of it.

Status

coreval is a personal open-source project. It is not a CDISC product, is not affiliated with or endorsed by CDISC, and is not qualified or validated software. The rules are bundled inside the package, so nothing is downloaded and your data never leaves your machine: no internet, no API key, no account.

Treat every result as a hint, not a verdict. A qualified validation system and your own review are still what decide whether data is good to submit. coreval does not remove that step - it just leaves that step less to find.

See also

Useful links:

Author

Maintainer: Hrach Gevorgyan hrach.gevorgyan@yandex.com [copyright holder]

Authors: