Pinnacle 21 Community 2.1.2 Release Notes
Released 25-Jul-2016
Validator
- Allow Literal value to be second argument of difference function (bug fix)
- Avoid race conditions to avoid exception "The variable VARIABLE does not exist in this DataRecord" (bug fix)
- Avoid specifying the same variable twice in global supplements (bug fix)
- Improve delimited file parser performance of MedDRA files (enhancement)
- Don't remove variables from supplemented record values since they can be useful (enhancement)
Define.xml Generator
- Fixed excel export to use generated where clause id instead of parsed id (bug fix)
- Fixed define validation failing on stylesheet element sharing a line with another element (bug fix)
- Fixed define excel import upload hanging (bug fix)
- Enhanced define validation performance (enhancement)
Data Converter
- Fixed default selected tab of exported Excel file to be first tab (bug fix)
Rules
- SDTM
- Removed SD1076 and SD1078 rules from custom domains (bug fix)
- Removed SD0063 and SD0063A rules from DA domain in SDTM 3.1.1 (bug fix)
- Changed SD0064 rules to always treat USUBJID as text (bug fix)
- Fixed SD2257-59 rules to correctly parse SNOMED files (bug fix)
- Changed SD1201 rule message to be more generic (enhancement)
- Changed SD1071 rule check for datasets larger than 5 GB per latest FDA guidance (enhancement)
- SEND
- Fixed order of variables in EX domain (bug fix)
- Changed LBORNRLO and LBORNRHI to text (bug fix)
- Changed SD1071 rule check for datasets larger than 5 GB per latest FDA guidance (enhancement)
- Define.xml
- Fixed DD0015 and DD0078 rules to prevent incorrect reporting of missing document references (bug fix)
- Updated to latest CDISC XML Schema that supports Analysis Results Metadata (enhancement)
- Added DD0000 notice to indicate that ARM was included in Define.xml (enhancement)
Dictionaries
- Fixed incorrect codelist reference for TSVALCD where TSPARAMCD=RANDOM (bug fix)
- Added automatic creation of MedDRA and SNOMED dictionary folders (enhancement)
- Added 2016-06-26 releases of CDISC SDTM and SEND controlled terminologies (enhancement)
- Added 2016-05-02, 2016-06-06, and 2016-07-05 releases of NDF-RT (enhancement)
- Added 2016-05-20 and 2016-07-06 release of UNII (enhancement)