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coreval 0.1.0

First release. The API is settled for 0.1.x; anything that changes will go through a deprecation cycle rather than disappearing.

A personal open-source project — not affiliated with or endorsed by CDISC, and not a CORE-certified engine. It’s a quick local check to run before your qualified validation tool, never instead of it.

What you can do with it

• Check one dataset with check_dataset() — a data frame you already have open, or a single .xpt, .sas7bdat or .csv file. No study folder needed. This is the one for when you’re mid-way through writing the code that builds a domain. coreval works out the domain from your DOMAIN column, or the file name. Rules that need a dataset you didn’t supply are skipped and say so, rather than being run against columns that aren’t there.
• Check a whole study with read_study() on a folder, then check_study(). It reads XPT, SAS and CSV, and picks up Define-XML (2.0 or 2.1) if it’s there. Reading everything at once is what makes the cross-dataset rules work.
• Read what’s wrong in plain language. Printing a result gives you a report grouped by problem, worst first, each described in words — “Variable value is not in correct ISO 8601 date or datetime format” — with the rows and values that caused it and the rule number at the end. The same description is on every row of $findings as an issue column, so a rule number is never the only thing you get.
• Findings are triaged, so the ones that are definitely wrong come first. CDISC Open Rules carry no severity field — Pinnacle 21’s Notes/Minor/Major/ Critical is P21’s own layer, not CDISC’s — so coreval does not report one and does not invent one. What it does is separate wrong value (your data breaks the rule: a month of 13, a value outside its codelist) from missing required and missing optional (often legitimate — a screen-failure subject, a variable your raw data does not carry yet). Sorting by row count alone put those in the wrong order. It is a triage column on every finding, so a spreadsheet can be sorted by it too.
• A whole-study report is grouped by dataset, with a summary of which dataset has the most problems before any detail, so you can see where the trouble is at a glance. print(result, n = 20, rows = 5) shows more.
• Rules that only say “at least one variable is missing” now name which ones. Both sets the rule compared are in the finding, so the difference between them is shown: missing required variables: SUBJID, SITEID, COUNTRY.
• See what couldn’t be checked, always, in a second table with a reason for each. An empty findings table can mean clean data or rules that never ran, and those look identical otherwise.
• Save it and track it with write_findings() to Excel or CSV. You get findings, skipped, an about sheet and - when a rule matched more records than were kept - truncated. The file carries empty Status, Owner and Notes columns for you to fill in, so “expected, see protocol deviation log” lives next to the finding instead of in another document. Pass tracking = FALSE to leave those out.
• Provenance travels with the exported file. about records which standard the run was scoped to, how many checks ran, whether the result was filtered before export, and whether any counts were capped. A shared spreadsheet outlives the console session that made it, and whoever opens it cannot otherwise tell that it is partial.
• Cross-refer to Pinnacle 21. Every rule now carries the legacy conformance-rule ids it descends from - CG0665, SEND66, TIG0699, FB0801 - which are the ids P21 and the published Conformance Rules spreadsheets use. The report shows them next to the CORE id, so a finding here can be matched to a finding there, including to a severity CDISC itself does not publish. All 797 rules have at least one.
• The “why”, from the Implementation Guide itself. Each rule carries the sentence it exists to enforce, with document and section: “The SENDIG requires dates and times of day to be stored according to the international standard ISO 8601 (SENDIG v3.0 4.4)”. print(result, guidance = TRUE) shows it under each problem - off by default, since it roughly doubles the report - and list_rules() always returns it.
• One function for every question about the rule set. list_rules() now answers all three: list_rules() for the catalog, list_rules(id = "CORE-000547") to look up a rule the report named, list_rules(domain = "AE") for what applies to a domain. The columns are the same whatever you ask, so the result is safe to filter, join and script against. rule_info(), rules_for_domain() and rules_version() are gone - the last is now attr(list_rules(), "rules_version"), and write_findings() records it in every exported file anyway.
• summary() gives the counts in three lines, for a script or a quick “did that fix help?”, and returns them as a row you can log.
• filter_findings() narrows a result by triage, dataset, rule or variable, and returns a result - so it still prints as a readable report, and says it is a subset rather than passing for the whole picture.
• A Getting started vignette walks through all of it, on a small study built as you read, so it runs without any data of your own.

Speed

• Checking is dramatically faster - roughly 50x on large data. Four things were doing per-row work on whole columns: the date operators called grepl()/regexpr() once per value; findings were assembled one data.table per violating record; the code building reported values re-decided what kind of thing each variable was for every row; and the uniqueness operators answered “does this key repeat?” by building an interaction factor and sorting it, rather than by hashing.

  rows	before	after
  10 000	37 s	1.1 s
  200 000	~12 min	18 s
  1 000 000	~1 hour	71 s

  Finding counts are identical at every size.

• Findings are capped at 1000 records per rule by default. A rule can flag every row - a missing EPOCH on a 200 000-row LB is 200 000 identical findings, beyond what anyone reads or Excel can hold. The true count is kept in the new truncated table and shown in the report (“1 000 000 records (first 1 000 kept)”), so nothing is under-reported. max_records = Inf keeps everything.

• A progress bar appears for long checks when running interactively, so a slow study no longer looks like a hang. options(coreval.progress = FALSE) turns it off; it is already off in scripts.

Fixed

• Factor columns no longer crash the check. A factor is text to every rule but an integer vector underneath, so the whole run died with 'nzchar()' requires a character vector. read.csv(stringsAsFactors = TRUE) and plenty of older code still produce factors, so they are converted rather than refused.
• A trailing blank in DOMAIN no longer changes the answer. "AE " was treated as a domain of that name: it scoped to a different rule set, and resolved "--STDTC" to "AE STDTC" - a column nothing has - so every "--" rule silently found nothing. (The padded value is still reported as a problem in its own right, by the rules that exist to catch exactly that.)
• A dataset with no rows, or an all-blank DOMAIN, says which it is. The old message claimed there was “no single DOMAIN value”, which reads as “your column is inconsistent” to someone whose data simply has no rows yet.
• days_in_month() was wrong for vector input: it built its lookup table with c(31, ifelse(leap, 29, 28), 31, ...), which produces one element per YEAR rather than one per month, so for n years the table was 11 + n long and every month from March on read the wrong slot. Correct for a single value and wrong for a column - which the old per-row date code hid completely. "2003-11-31" was rejected when checked alone and accepted when checked as part of a column.

Fewer rules, better aimed

• Rules are scoped to the standard your data follows. standard = "SDTMIG" was accepted and silently ignored before, so an SDTM study was also measured against SENDIG rules - 73 of the 270 rules in scope for DM are SENDIG-only. Declaring it now halves the rules and more than halves the reported problems, losing no real coverage. Matched exactly, so a SENDIG study does not pick up SENDIG-DART rules.
• Rules are scoped to the Implementation Guide VERSION too, when you declare one: check_dataset(dm, standard = "SDTMIG", version = "3.4"). Rules are written per version - 408 SDTMIG rules exist for 3.2 against 445 for 3.4, and 86 apply to exactly one version - so without this a 3.2 study is measured against rules written for a guide it does not follow. "3-4" and "3.4" are both accepted, since CORE test cases write the first and the rules the second.
• Deprecated rules are no longer run unless you ask for them with include_deprecated = TRUE. A deprecated rule has a published replacement, so running both reports the same defect twice.
• Together these are why one problem could appear three times: once from the SDTMIG rule, once from its SENDIG equivalent, once from a deprecated predecessor. Declaring the standard now reports it once.
• When no standard is declared, every standard’s rules still run - coreval does not guess - but the report says so, instead of quietly reporting SEND findings on SDTM data.

Licensing and API

• The MIT notice for the bundled CDISC material now ships with the package, in inst/COPYRIGHTS. cdisc-open-rules is MIT licensed, and MIT requires the copyright and permission notice to accompany substantial portions of the work - coreval bundles 797 extracted rules and CDISC standards metadata, but the notice lived only in NOTICE.md, which is excluded from the build and so never reached anyone who installed the package. A test now guards it.
• check_study() takes a folder path, so read_study() is now optional: check_study("study/sdtm") instead of reading first. Reading yourself is still worth it to inspect what was parsed, or to check the same large study twice without re-reading it.
• sdtm_domain_classes() is no longer exported - a domain-to-class lookup table answers a question nobody working with their own data has.
• evaluate_rule() is no longer exported. It returned a raw logical vector, needed a rule record fetched from package internals, and had no story a user could follow now that check_dataset() exists.

Coverage

• 41 more rules, from Unpublished/SDTMIG and Unpublished/SENDIG - folders the extractor never opened. Both are SDTM- and SEND-shaped, so this engine can read their data, and only the ones CDISC already ships expected results for are taken (11 of 128, and 30 of 77). That is the whole remaining gap: of the 767 upstream rules in a readable format that CDISC ships results for, coreval now has 767.
• Still excluded, and why: USDM (259 rules) is a JSON study-design model, not tabular datasets - read_study() cannot read it at all. Unpublished/ADAMIG (93) ships test data but no expected results for a single rule, so nothing there can be verified. Another 292 readable rules have no expected results either.
• Two new operators, contains_case_insensitive and does_not_contain_case_insensitive.
• 13 TIG domains added to the domain-to-class table. It claimed to cover TIG and did not: 42 of the 55 TIG domains happen to be shared with SDTM/SEND and resolved by accident, while TO, PT, IN, RELREF and nine others resolved to nothing. Every rule scoped to one failed its Scope > Classes check and was skipped as “no dataset matches the rule’s scope” - with the right dataset sitting in the test case. Taken from the same CDISC cache as the rest of the table, and checked against the 42 shared domains first: no conflicts.

What’s covered

• 797 rules for SDTM, SEND and TIG, bundled inside the package. Nothing is downloaded — no internet, no API key, no account, and your data stays put.
• Around 60 rule operators, including comparison of partial dates (SDTM dates are legitimately incomplete, like 2024-03), grouping and uniqueness checks, and set membership.
• Cross-dataset joins — RELREC relationships, SUPP/SQ supplemental qualifiers, and parent-child joins — plus the Operations pipeline that pre-computes values rules refer to.
• CDISC Library variable metadata for SDTM, SEND, ADaM and TIG, so rules comparing your variables against the standard’s can actually run, and SEND studies are checked against SEND metadata rather than refused. Taken at build time from the offline cache CDISC’s own engine ships with; no CDISC API is contacted, ever.

How much you can trust it

• Checked by replaying CDISC’s own reference test cases and comparing flagged records one by one. It currently agrees with CDISC on 540 of 562 published, fully executable rules that ship reference data — about 96%. The README explains the other denominators and why there’s more than one.
• A rule that can’t be evaluated is always reported as skipped, with a reason, never counted as a pass.

What it can’t do yet

• No ADaM rules. CDISC publishes 93 of them, but none currently ships reference results, so there’s no published expected output to check an implementation against. Including them would mean asking you to trust checks nobody has verified. They go in as soon as that data exists.
• No Controlled Terminology term lists. That data runs to roughly 438 MB and belongs in a separate package. The CT package dates are bundled, so rules checking that a study cites a real terminology version do run.
• Split domains are handled for uniqueness — a value appearing once in each of two files is correctly reported as a duplicate. A few rules that expect findings merged under one dataset name, rather than reported per file, are still skipped.
• Numbers are reported as parsed, so a source value of 0.0 comes back as 0.
• Not a CORE-certified engine. These figures describe agreement with CDISC’s published reference data. They aren’t certification.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.