Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist Change Summary Original New 2012-03-23 P9 N/A C100391; C100390 Term SDTM-EGTEST; SDTM-EGTESTCD Two additions to the EGTEST and EGTESTCD codelist. - - - See Published SDTM Spreadsheet 2012-03-23 P9 N/A C17445 Synonym SDTM-EVAL Addition of synonym to match other codelists. - - - SY: Caregiver 2012-03-23 P9 N/A C62649 Synonym SDTM-EVAL Addition of synonym to match other codelists. - - - SY: Spouse 2012-03-23 P9 N/A C53262 Synonym SDTM-EVAL; SDTM-MARISTAT Addition of synonym to match other codelists. - - - SY: Domestic Partner 2012-03-23 31863 I C60957 Submission Value SDTM-FRM Please update the term 'LOTION. AUGMENTED' in the Pharmaceutical Dosage Form codelist to 'LOTION, AUGMENTED'. Having a comma rather than a period is consistent with the other terms in the Pharmaceutical Dosage Form codelist. PT: LOTION. AUGMENTED PT: LOTION, AUGMENTED 2012-03-23 31967 I C68598 C-code SDTM-LAT Change c-code for UNILATERAL from C68598 to C28012 C68598 C28012 2012-03-23 31501 I C96615 C-code SDTM-LBTEST; SDTM-LBTESTCD Change NCI c-code of C96615. Term has been merged into C60832. C96615 C68032 2012-03-23 P9 N/A C81958 Synonym SDTM-LBTEST; SDTM-LBTESTCD Add synonyms. SY: Antithrombin; Antithrombin III SY: Antithrombin; Antithrombin III; Antithrombin Activity; Antithrombin III Activity 2012-03-23 P9 N/A C92236 Synonym SDTM-LBTEST; SDTM-LBTESTCD Add synonyms. SY: Sjogrens SS-A Antibody SY: Ro Antibody; Sjogrens SS-A Antibody 2012-03-23 P9 N/A C92237 Synonym SDTM-LBTEST; SDTM-LBTESTCD Add synonyms. SY: Sjogrens SS-B Antibody SY: La Antibody; Sjogrens SS-B Antibody 2012-03-23 P9 N/A C80160 Synonym SDTM-LBTEST; SDTM-LBTESTCD Remove synonyms. SY: Complement Total; CH50; Total Hemolytic Complement SY: Complement Total 2012-03-23 P9 N/A MULTIPLE Term SDTM-LBTEST; SDTM-LBTESTCD 57 additions to the LBTEST and LBTESTCD codelist. - - - See Published SDTM Spreadsheet 2012-03-23 31913 I C33491; C32973 Submission Value; Synonym; Definition SDTM-LOC The submission value is switched for the terms THYROID GLAND, LEFT LOBE and THYROID GLAND, RIGHT LOBE. C33491 PT: THYROID GLAND, LEFT LOBE; C32973 PT: THYROID GLAND, RIGHT LOBE C33491 PT: THYROID GLAND, RIGHT LOBE; C32973 PT: THYROID GLAND, LEFT LOBE 2012-03-23 C31964 I C78728 C-code SDTM-PORTOT Change c-code for MULTIPLE from C78728 to C17648 C78728 C17648 2012-03-23 P9 N/A C100758 Term SDTM-POSITION 1 addition to the SDTM-POSITION codelist - - - See Published SDTM Spreadsheet 2012-03-23 P9 N/A C100130 New SDTM Codelist SDTM-RELSUB Addition of the new 'Relationship to Subject' codelist for SDTM, including 47 valid values. - - - See Published SDTM Spreadsheet 2012-03-23 P9 N/A C77613; C100896; C33718 Term SDTM-SPECTYPE 3 additions to the SDTM-SPECTYPE codelist - - - See Published SDTM Spreadsheet 2012-03-23 P9 N/A C92431 Term SDTM-TSPARM; SDTM-TSPARMCD Retire RANDRAT/Ratio for Randomization; new parameter RANDQT was approved with Package 8. PT: RANDRAT/Ratio for Randomization C92431 - - - 2012-03-23 P9 N/A C16153 Term SDTM-TSPARM; SDTM-TSPARMCD Retire RANDSTR/Stratification for Randomization ; new parameter STRATFCT was approved with Package 8. PT: RANDSTR/Stratification for Randomization C16153 - - - 2012-03-23 31856 I C49667 Definition SDTM-TTYPE Add spaces between words in definition. Def: A studythat assessesthemedical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, includingadverse events, vital signs, physical exam, laboratory tests. Def: A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests. 2012-03-23 31859 I C71187 Submission Value SDTM-UNIT Please update the term '10^3 Organisms' in the Unit codelist to '10^3 organisms'. Having organisms start with a lower case o is consistent with the other terms in the Unit codelist. PT: 10^3 Organisms PT: 10^3 organisms 2012-03-23 31860; 31878 I C68899 Submission Value SDTM-UNIT Please update the term '10^ 3 CFU/g' in the Unit codelist to '10^3 CFU/g'. Removing the space between the ^ and the 3 is consistent with the other terms in the Unit codelist PT: 10^ 3 CFU/g PT: 10^3 CFU/g 2012-03-23 31877 I C48571 Submission Value SDTM-UNIT change "% (v/v)" to "%(v/v)" - remove space to be consistent with other terms PT: % (v/v) PT: %(v/v) 2012-03-23 P9 N/A C67456 Synonym SDTM-UNIT Add synonyms. SY: Unit per Liter SY: mU/mL; Unit per Liter 2012-03-23 P9 N/A MULTIPLE Term SDTM-UNIT 7 additions to the SDTM-UNIT codelist - - - See Published SDTM Spreadsheet 2012-03-23 31896 I C67396 Synonym SDTM-UNIT; SDTM-PKUNIT The synonym for C67396 - ug/kg is 'mcg/kg; Microgram per Kilogram; ng/g; ug/k'. Shouldn't this last synonym be ug/kg? SY: mcg/kg; Microgram per Kilogram; ng/g; ug/k SY: mcg/kg; Microgram per Kilogram; ng/g; ug/kg 2012-03-23 P9 N/A MULTIPLE Term SDTM-VSTEST; SDTM-VSTESTCD 5 additions to the VSTEST and VSTESTCD codelist. - - - See Published SDTM Spreadsheet