Pinnacle 21 Community 2.1.0 Release Notes

Released 07-Dec-2015

General

• Rebranded OpenCDISC Community to Pinnacle 21 Community (maintenance)
• Added diagnostic information to bug report emails (enhancement)

Validator

• Fixed variable properties not being replaced correctly when more than one substitution was present (bug fix)
• Fixed issue where define.xml value level metadata could interfere with terminology data (bug fix)
• Added ability to select CDISC CT version for Define.xml validation (enhancement)
• Added XML Schema checking for Define.xml validation (enhancement)
• Migrated Define.xml validation process from the Validator to the Define.xml Generator (enhancement)
• Exposed additional properties for value level metadata in configuration parser (enhancement)
• Changed rule metrics collection for efficiency (enhancement)
• Added new post-configuration event (enhancement)
• Added TS variables as supplemental data to records (enhancement)
• Added DyAdd function for expressions (enhancement)
• Added support for constants in expression functions (enhancement)
• Added Reject message Type (enhancement)
• Added support for conditional rule severities (enhancement)
• Deprecated Type parameter in validator API due to non-use (maintenance)
• Change Information to Notice in Type enumeration (maintenance)

Define.xml Generator

• Improved error reporting for Excel template structural issues (enhancement)
• Fixed CDISC stylesheet in case Where Clause range check links to variables in different domain (bug fix)
• Fixed issue where numeric values would occasionally get converted to scientific notation (bug fix)

Rule and Dictionaries

• Added PMDA validation rule configs for SDTM 3.1.2, 3.1.3, 3.2, ADaM 1.0, and Define.xml (enhancement)
• Updated rule messages and descriptions to correct spelling/grammar and make them consistent across FDA and PMDA (enhancement)
• Added 2015-07-06, 2015-09-07, 2015-10-05, and 2015-11-02 releases of NDF-RT (enhancement)
• Added 2015-09-01 and 2015-11-12 releases of UNII (enhancement)
• Added 2015-09-25 releases of SDTM and SEND controlled terminologies (enhancement)
• Updated ADaM 1.0 validation rule config:
  • Added 73 of 75 CDISC ADaM Validation Checks v1.3 primarily for ADTTE and ADAE, covered by ~42 new ADaM rules (enhancement)
  • Added 4 flag N variables to BDS: CHGCATyN,PCHGCAyN,AVALCAyN,BASECAy (enhancement)
  • Added 4 treatment variables (ADSL copies) of TRT*P, TRT*PN,TRT*A,TRT*AN since these are listed in BDS-TTE IG 1.0 (enhancement)
  • Added CNSR,CNSDTDSC,EVNTDESC variables to BDS prototype (enhancement)
  • Added "UNRECOGNIZED" prototype to account for ADaM datasets that are not ADSL, BDS, ADAE (enhancement)
  • Added 16 "no-logic/not implemented" rule placeholders for book-keeping traceability to CDISC ADaM Validation rules (enhancement)
  • Removed AD1014 as this was not a valid rule (bug fix)
  • Removed ADTTE and TTE datasets as these are subsets of BDS. Move any TTE specific variables part of ADaM 1.1 to BDS. (enhancement)
  • Assigned SD0001 to all domains - No records in data source (enhancement)
  • Enhanced all val:Core values of "Conditionally required" to "Conditional" for consistency (enhancement)
  • Enhanced variable roles to remove redundant " Variables" phrase as in "Treatment Variables" (enhancement)
  • Enhanced rule message and descriptions to be more consistent and inline with PMDA requirements (enhancement)
  • Enhanced AD0196 to ensure ASEVN is populated when present. (enhancement)
  • Enhanced AD0159 to include ADY and ARELTM to fire if all 3 variables are not present (enhancement)
  • Enhanced AD0158 description to relate it to AD0159 (enhancement)
  • Fixed ADAE class from OTHER to ADAE as prescribed by ADaM ADAE IG (bug fix)
  • Fixed ADAE labels that included a ZZ and XX to $1 so that they are evaluated at runtime appropriately (bug fix)
  • Fixed logic for AD0247 to use OR clause AVAL != '' and STARTDT != '' and (ADT != '' or ADTM != '') (bug fix)
  • Fixed non-ADAE unique/consistency rules to include STUDYID when checking for consistency. This prevents IDB (integrated DBs) false positives (bug fix)
  • Fixed AD0221 to only execute when *CATy variables are not null (bug fix)
  • Fixed AD1012 to exclude CNSDTDSC variable (bug fix)
  • Fixed AD1013 to check BASEC as well (bug fix)
  • Fixed AD0188 to allow the N version of the variable: CHGCATy(N) - ADaM IG 1.1 preview (bug fix)
  • Fixed AD0042 to exclude ARELTM variable from being evaluated since that is not a SAS time variable (bug fix)
  • Fixed SD0054,SD0061 to have attribute set as MatchExact=No (no affect to validation, explicit syntax display) (bug fix)
  • Renamed rule codes to be consistent with their source CDISC ADaM Validation checks (and in anticipation of FDA rule IDs). These checks cover multiple CDISC adam rules. (maintenance)
• Revised Define.xml validation:
  • Initial release
  • Replaced Define.xml 1.0 and Define.xml 2.0, which were combined into a single config to ease maintenance (enhancement)
  • Removed ODxxxx Validation Rules: OD0015, OD0016, OD0018, and OD0020 (maintenance)
  • Replaced ODxxxx Validation Rules: OD0002 -> DD0002, OD0003 -> DD0003, OD0006 -> DD0006, OD0009 -> DD0009, and OD0014 -> OD0077 (maintenance)
  • Added 57 new DDxxxx Validation Rules: DD0001, DD0031-86 (enhancement)
  • Removed DDxxxx Validation Rules: DD0005, DD0023 (maintenance)
  • Replaced DDxxxx Validation Rules: DD0026 -> DD0006, DD0027 -> DD0031-34 (maintenance)