Release Date	Request Code	Change Type	NCI Code	CDISC Term Type	CDISC Codelist	Change Summary	Original	New
2011-12	31476	II	C66781	Definition	SDTM-AGEU	Change definition of Codelist Term to allow SEND usage.	Def: Those units of time that are routinely used to express the age of a person. (NCI)	Def: Those units of time that are routinely used to express the age of a subject.
2011-12	31452	III	C64374	Submission Value	SDTM-COUNTRY	Change CDISC submission value from JRE to JEY. ISO update.	PT: JRE	PT: JEY
2011-12	31453	III	C64377	Submission Value	SDTM-COUNTRY	Change CDISC submission value from SCG to SRB. ISO update.	PT: SCG	PT: SRB
2011-12	31454	II	C16695	Synonym	SDTM-COUNTRY	Remove HKG as a synonym. HKG is the submission value and we don't put the three letter ISO codes in as synonyms.	SY: HKG; HONG KONG	SY: HONG KONG
2011-12	P7-P8	III	C99074	Codelist	SDTM-DIR	Addition of a new Directionality Codelist for SDTM and SEND.	- - -	Addition of 29 terms to a new codelist.
2011-12	P7-P8	II	C95099	Submission Value	SDTM-DOMAIN	Rename duplicate two-letter domain name.	PT: ST	PT: SJ
2011-12	31472	II	C49619	Synonym	SDTM-DOMAIN	Remove TE as a synonym. TE is the Submission value.	SY: TE; Trial Elements	SY: Trial Elements
2011-12	P7-P8	III	MULTIPLE	Submission Values	SDTM-FREQ	Addition of new terminology to existing codelist.	See published spreadsheet 2011-07-22	Addition of 17 terms to an existing codelist.
2011-12	31474	II	C67069	Synonym	SDTM-FREQ	Addition of synonym in SDTM-FREQ codelist due to use of terms in other codelists.	SY: Every week	SY: Every week; Per Week
2011-12	P7-P8	III	C99073	Codelist	SDTM-LAT	Addition of a new Laterality Codelist for SDTM and SEND.	- - -	Addition of 7 terms to a new codelist.
2011-12	31432; 31433	II	C92270	Synonym	SDTM-LBTEST; SDTM-LBTESTCD	Addition of synonym	SY: Anti-ENA	SY: Anti-ENA; Extractable Nuclear Antigen Antibody
2011-12	P7-P8	II	C64850	Synonym	SDTM-LBTEST; SDTM-LBTESTCD	Addition of synonym	SY: Hepatitis B Virus Surface Antigen	SY: HBsAg; Hepatitis B Virus Surface Antigen
2011-12	P7-P8	II	C64857	Synonym	SDTM-LBTEST; SDTM-LBTESTCD	Addition of synonym	SY: Phosphate; Phosphorus	SY: Phosphate; Phosphorus; Inorganic Phosphate
2011-12	P7-P8	II	C74711	Synonym	SDTM-LBTEST; SDTM-LBTESTCD	Addition of synonym	SY: Hepatitis B Virus Surface Antibody	SY: Anti-HBs; HBsAb; Hepatitis B Virus Surface Antibody
2011-12	P7-P8	II	C92291	Synonym	SDTM-LBTEST; SDTM-LBTESTCD	Edit existing synonym	SY: Monoclonal Protein; Paraprotein	SY: Monoclonal Immunoglobulin Protein; Paraprotein
2011-12	P7-P8	II	C96636	Synonym	SDTM-LBTEST; SDTM-LBTESTCD	Addition of synonym	SY: Target Cells	SY: Leptocytes; Target Cells
2011-12	P7-P8	II	C42576	Synonym	SDTM-UNIT	Addition of synonym	SY: Kilogram per Cubic Meter; g/L; Gram per Liter; ug/uL; Microgram per Microliter; Milligram per Milliliter	SY: Kilogram per Cubic Meter; Gram per Liter; ug/uL; Microgram per Microliter; Milligram per Milliliter; kg/m3; mg/mL; g/L
2011-12	P7-P8	II	C67335	Synonym	SDTM-UNIT	Addition of synonym	SY: Million International Units	SY: Million International Units; Million IU
2011-12	P7-P8	II	C68858	Synonym	SDTM-UNIT	Addition of synonym	SY: Standard Cubic Meter	SY: Standard Cubic Meter; m3
2011-12	P7-P8	II	C68895	Synonym	SDTM-UNIT	Addition of synonym	SY: Thousand Colony Forming Units	SY: Thousand Colony Forming Units; Thousand CFU
2011-12	P7-P8	II	C68896	Synonym	SDTM-UNIT	Addition of synonym	SY: Million Colony Forming Units	SY: Million Colony Forming Units; Million CFU
2011-12	P7-P8	II	C68897	Synonym	SDTM-UNIT	Addition of synonym	SY: Billion Colony Forming Units	SY: Billion Colony Forming Units; Billion CFU
2011-12	P7-P8	II	C68899	Synonym	SDTM-UNIT	Addition of synonym	SY: Thousand Colony Forming Units per Gram	SY: Thousand Colony Forming Units per Gram; Thousand CFU/g
2011-12	P7-P8	II	C68900	Synonym	SDTM-UNIT	Addition of synonym	SY: Million Colony Forming Units per Gram	SY: Million Colony Forming Units per Gram; Million CFU/g
2011-12	P7-P8	II	C68901	Synonym	SDTM-UNIT	Addition of synonym	SY: Billion Colony Forming Units per Gram	SY: Billion Colony Forming Units per Gram; Billion CFU/g
2011-12	P7-P8	II	C68903	Synonym	SDTM-UNIT	Addition of synonym	SY: Thousand Colony Forming Units per Milliliter	SY: Thousand Colony Forming Units per Milliliter; Thousand CFU/mL
2011-12	P7-P8	II	C68904	Synonym	SDTM-UNIT	Addition of synonym	SY: Million Colony Forming Units per Milliliter	SY: Million Colony Forming Units per Milliliter; Million CFU/mL
2011-12	P7-P8	II	C68905	Synonym	SDTM-UNIT	Addition of synonym	SY: Billion Colony Forming Units per Milliliter	SY: Billion Colony Forming Units per Milliliter; Billion CFU/mL
2011-12	P7-P8	II	C71190	Synonym	SDTM-UNIT	Addition of synonym	SY: Thousand Organisms per Gram	SY: Thousand Organisms per Gram; Thousand Organisms/g
2011-12	P7-P8	II	C71191	Synonym	SDTM-UNIT	Addition of synonym	SY: Million Organisms per Gram	SY: Million Organisms per Gram; Million Organisms/g
2011-12	P7-P8	II	C71192	Synonym	SDTM-UNIT	Addition of synonym	SY: Billion Organisms per Gram	SY: Billion Organisms per Gram; Billion Organisms/g
2011-12	P7-P8	II	C71193	Synonym	SDTM-UNIT	Addition of synonym	SY: Million Organisms per Milligram	SY: Million Organisms per Milligram; Million Organisms/mg
2011-12	P7-P8	II	C71194	Synonym	SDTM-UNIT	Addition of synonym	SY: Billion Organisms per Milligram	SY: Billion Organisms per Milligram; Billion Organisms/mg
2011-12	P7-P8	II	C71195	Synonym	SDTM-UNIT	Addition of synonym	SY: Thousand Organisms per Milliliter	SY: Thousand Organisms per Milliliter; Thousand Organisms/mL
2011-12	P7-P8	II	C71196	Synonym	SDTM-UNIT	Addition of synonym	SY: Million Organisms per Milliliter	SY: Million Organisms per Milliliter; Million Organisms/mL
2011-12	P7-P8	II	C71197	Synonym	SDTM-UNIT	Addition of synonym	SY: Billion Organisms per Milliliter	SY: Billion Organisms per Milliliter; Billion Organisms/mL
2011-12	P7-P8	III	C42576	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: kg/m3	PT: g/L
2011-12	P7-P8	III	C64572	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: g/m3	PT: mg/L
2011-12	P7-P8	III	C67327	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: ug/m3	PT: ng/L
2011-12	P7-P8	II	C67335	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million IU	PT: 10^6 IU
2011-12	P7-P8	III	C68858	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: m3	PT: scm
2011-12	P7-P8	II	C68895	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: thousand CFU	PT: 10^3 CFU
2011-12	P7-P8	II	C68896	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million CFU	PT: 10^6 CFU
2011-12	P7-P8	II	C68897	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion CFU	PT: 10^9 CFU
2011-12	P7-P8	II	C68899	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: thousand CFU/g	PT: 10^ 3 CFU/g
2011-12	P7-P8	II	C68900	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million CFU/g	PT: 10^6 CFU/g
2011-12	P7-P8	III	C92241	Submission Value	SDTM-LBTEST; SDTM-LBTESTCD	Shorten submission value to 40 characters or less.	PT: Mycobacterium tuberculosis IFN Gamma Response	PT: M. tuberculosis IFN Gamma Response
2011-12	P7-P8	III	C92533	Submission Value	SDTM-LBTEST; SDTM-LBTESTCD	Shorten submission value to 40 characters or less.	PT: Soluble Vascular Cell Adhesion Molecule 1	PT: Soluble Vasc Cell Adhesion Molecule 1
	P7-P8	III	MULTIPLE	Submission Values	SDTM-LBTEST; SDTM-LBTESTCD	Addition of a new terms to SDTM-LBTEST and SDTM-LBTESTCD codelist.	See published spreadsheet 2011-07-22	Addition of 51 terms to an existing codelist.
2011-12	P7-P8	II	C68901	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion CFU/g	PT: 10^9 CFU/g
2011-12	P7-P8	II	C68903	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: thousand CFU/mL	PT: 10^3 CFU/mL
2011-12	P7-P8	II	C68904	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million CFU/mL	PT: 10^6 CFU/mL
2011-12	P7-P8	II	C68905	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion CFU/mL	PT: 10^9 CFU/mL
2011-12	P7-P8	III	C71187	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: thousand Organisms	PT: 10^3 Organisms
2011-12	P7-P8	III	C71188	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million Organisms	PT: 10^6 organisms
2011-12	31467	II	C48153	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	mcL	mcL; Microliter; mm3
2011-12	31467	II	C64387	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	Micromole per Milliliter; Millimole per Liter; mol/m3; Mole per Cubic Meter; mmol/L	Micromole per Milliliter; Millimole per Liter; mol/m3; Mole per Cubic Meter; mmol/L; mcmol/mL; nmol/uL; umol/mL
2011-12	31467	II	C64566	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	Gram per Milliliter; Kilogram per Liter	Kilogram per Liter; g/mL; Gram per Milliliter; gram/mL; kg/L; mg/uL
2011-12	31467	II	C64572	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	g/m3; Gram per Cubic Meter; mg/L; Microgram per Milliliter; Milligram per Liter	g/m3; Gram per Cubic Meter; mg/L; Microgram per Milliliter; Milligram per Liter; mcg/mL; ng/uL; ug/mL
2011-12	31467	II	C67306	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL	mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL; mcg/L
2011-12	31467	II	C67394	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	Micrograms per Hour	Micrograms per Hour; mcg/h
2011-12	31467	II	C67396	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	Microgram per Kilogram; mcg/kg	mcg/kg; Microgram per Kilogram; ng/g; ug/kg
2011-12	31467	II	C67405	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	mIU/L; mcIU/mL; uIU/mL	Micro-International Unit per milliliter; mIU/L; mcIU/mL; uIU/mL
2011-12	31467	II	C69073	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	- - -	mL/sec
2011-12	31467	II	C73755	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d	Milliliter per Gram per Day; mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d
2011-12	31467	II	C73758	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	- - -	Milliliter per Kilogram per Day
2011-12	31467	II	C73759	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	- - -	Milliliter per Kilogram per Hour
2011-12	31467	II	C73760	Synonym	SDTM-PKUNIT	Addition of synonyms in SDTM-PKUNIT codelist due to use of terms in SDTM-UNIT codelist.	uL/g/min; mL/min/kg; uL/min/g; mL/kg/min	Milliliter per Kilogram per Minute; uL/g/min; mL/min/kg; uL/min/g; mL/kg/min
2011-12	P7-P8	III	C99075	Codelist	SDTM-PORTOT	Addition of a new Portion Totality Codelist for SDTM and SEND.	- - -	Addition of 6 terms to a new codelist.
2011-12	P7-P8	III	C71189	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion Organisms	PT: 10^9 organisms
2011-12	P7-P8	III	C71190	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: thousand organisms/g	PT: 10^3 organisms/g
2011-12	P7-P8	III	C71191	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million organisms/g	PT: 10^6 organisms/g
2011-12	P7-P8	III	C71192	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion organisms/g	PT: 10^9 organisms/g
2011-12	P7-P8	III	C71193	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million organisms/mg	PT: 10^6 organisms/mg
2011-12	P7-P8	III	C71194	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion organisms/mg	PT: 10^9 organisms/mg
2011-12	P7-P8	III	C71195	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: thousand organisms/mL	PT: 10^3 organisms/mL
2011-12	P7-P8	III	C71196	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: million organisms/mL	PT: 10^6 organisms/mL
2011-12	P7-P8	III	C71197	Submission Value	SDTM-UNIT	CDISC submission value update.	PT: billion organisms/mL	PT: 10^9 organisms/mL
2011-12	P7-P8	III	C64434	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the pancreatic enzyme amylase in a biological specimen.	Def: A measurement of the total enzyme amylase in a biological specimen.
2011-12	P7-P8	III	C74698	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the round epithelial cells present in a urine specimen.	Def: A measurement of the round epithelial cells present in a biological specimen.
2011-12	P7-P8	III	C74718	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the amount of iron needed to fully saturate the transferrin in a serum specimen.	Def: A measurement of the amount of iron needed to fully saturate the transferrin in a biological specimen.
2011-12	P7-P8	III	C74753	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A relative measurement (ratio or percentage) (ratio) of the blood urea nitrogen (BUN) to the creatinine in a blood specimen.	Def: A relative measurement (ratio or percentage) (ratio) of the blood urea nitrogen (BUN) to the creatinine in a biological specimen.
2011-12	P7-P8	III	C74754	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the hippuric acid crystals present in a urine specimen.	Def: A measurement of the hippuric acid crystals present in a biological specimen.
2011-12	P7-P8	III	C74755	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the sulfa crystals present in a urine specimen.	Def: A measurement of the sulfa crystals present in a biological specimen.
2011-12	P7-P8	III	C74756	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the triple phosphate crystals present in a urine specimen.	Def: A measurement of the triple phosphate crystals present in a biological specimen.
2011-12	P7-P8	III	C74757	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the unclassifiable crystals present in a urine specimen.	Def: A measurement of the unclassifiable crystals present in a biological specimen.
2011-12	P7-P8	III	C74761	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A relative measurement (ratio or percentage) of the albumin to the creatinine in a urine specimen.	Def: A relative measurement (ratio or percentage) of the albumin to the creatinine in a biological specimen.
2011-12	P7-P8	III	C74762	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the bacterial casts present in a urine specimen.	Def: A measurement of the bacterial casts present in a biological specimen.
2011-12	P7-P8	III	C74764	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the cellular (white blood cell, red blood cell, epithelial and bacterial) casts present in a urine specimen.	Def: A measurement of the cellular (white blood cell, red blood cell, epithelial and bacterial) casts present in a biological specimen.
2011-12	P7-P8	III	C74765	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the coarse granular casts present in a urine specimen.	Def: A measurement of the coarse granular casts present in a biological specimen.
2011-12	P7-P8	III	C74766	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the fatty casts present in a urine specimen.	Def: A measurement of the fatty casts present in a biological specimen.
2011-12	P7-P8	III	C74768	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the granular (coarse and fine) casts present in a urine specimen.	Def: A measurement of the granular (coarse and fine) casts present in a biological specimen.
2011-12	P7-P8	III	C74769	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the fine granular casts present in a urine specimen.	Def: A measurement of the fine granular casts present in a biological specimen.
2011-12	P7-P8	III	C74770	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the hyaline casts present in a urine specimen.	Def: A measurement of the hyaline casts present in a biological specimen.
2011-12	P7-P8	III	C74771	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the mixed (the cast contains a mixture of cell types) casts present in a urine specimen.	Def: A measurement of the mixed (the cast contains a mixture of cell types) casts present in a biological specimen.
2011-12	P7-P8	III	C74772	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the red blood cell casts present in a urine specimen.	Def: A measurement of the red blood cell casts present in a biological specimen.
2011-12	P7-P8	III	C74773	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the squamous epithelial cells present in a urine specimen.	Def: A measurement of the squamous epithelial cells present in a biological specimen.
2011-12	P7-P8	III	C74774	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the squamous transitional epithelial cells present in a urine specimen.	Def: A measurement of the squamous transitional epithelial cells present in a biological specimen.
2011-12	P7-P8	III	C74775	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the tubular epithelial cells present in a urine specimen.	Def: A measurement of the tubular epithelial cells present in a biological specimen.
2011-12	P7-P8	III	C74776	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the unclassifiable casts present in a urine specimen.	Def: A measurement of the unclassifiable casts present in a biological specimen.
2011-12	P7-P8	III	C74777	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the waxy casts present in a urine specimen.	Def: A measurement of the waxy casts present in a biological specimen.
2011-12	P7-P8	III	C74778	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the white blood cell casts present in a urine specimen.	Def: A measurement of the white blood cell casts present in a biological specimen.
2011-12	P7-P8	III	C74779	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the epithelial cell casts present in a urine specimen.	Def: A measurement of the epithelial cell casts present in a biological specimen.
2011-12	P7-P8	III	C74894	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: The ratio of albumin to globulin in a blood specimen.	Def: The ratio of albumin to globulin in a biological specimen.
2011-12	P7-P8	III	C74897	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the Vitamin B17 in a serum specimen.	Def: A measurement of the Vitamin B17 in a biological specimen.
2011-12	P7-P8	III	C80166	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A relative measurement (ratio or percentage) of the alpha glutathione-S-transferase to creatinine in a urine specimen.	Def: A relative measurement (ratio or percentage) of the alpha glutathione-S-transferase to creatinine in a biological specimen.
2011-12	P7-P8	III	C80171	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A relative measurement (ratio or percentage) of total cholesterol to high-density lipoprotein cholesterol (HDL-C) in a blood specimen.	Def: A relative measurement (ratio or percentage) of total cholesterol to high-density lipoprotein cholesterol (HDL-C) in a biological specimen.
2011-12	P7-P8	III	C80187	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 2 in a blood specimen.	Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 2 in a biological specimen.
2011-12	P7-P8	III	C80188	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 3 in a blood specimen.	Def: A measurement of the high-density lipoprotein (HDL) cholesterol subclass 3 in a biological specimen.
2011-12	P7-P8	III	C81947	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the oval-shaped fat bodies in a biological specimen.	Def: A measurement of the oval-shaped fat bodies, usually renal proximal tubular cells with lipid aggregates in the cytoplasm, in a biological specimen.
2011-12	P7-P8	III	C81962	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the range of platelet sizes in a blood specimen.	Def: A measurement of the range of platelet sizes in a biological specimen.
2011-12	P7-P8	III	C81974	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the antibody or complement-coated erythrocytes in a blood specimen in vivo.	Def: A measurement of the antibody or complement-coated erythrocytes in a biological specimen in vivo.
2011-12	P7-P8	III	C82044	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the indican present in a urine specimen.	Def: A measurement of the indican present in a biological specimen.
2011-12	P7-P8	III	C92251	Definition	SDTM-LBTEST; SDTM-LBTESTCD	Definition update.	Def: A measurement of the transitional epithelial cells present in a urine specimen.	Def: A measurement of the transitional epithelial cells present in a biological specimen.
2011-12	P7-P8	II	C67335	Definition	SDTM-UNIT	Definition update.	Def: A unit of biological activity equal to one million international units.(NCI)	Def: A unit of biological activity equal to 10 to the sixth power international units.
2011-12	P7-P8	III	MULTIPLE	Submission Values	SDTM-UNIT	Addition of new terminology to existing codelist.	See published spreadsheet 2011-07-22	Addition of 20 terms to an existing codelist.
2011-12	P7-P8	II	C68895	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial numbers equal to 10E3 colony forming units.(NCI)	Def: A unit of measurement of viable bacterial numbers equal to 10 to the third power colony forming units.
2011-12	31470	II	C42576	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: g/L; Gram per Liter; kg/m3; Kilogram per Cubic Metre; Microgram per Microliter; Milligram per Milliliter; ug/uL	SY: g/L; Gram per Liter; kg/m3; Kilogram per Cubic Metre; Microgram per Microliter; Milligram per Milliliter; ug/uL; mg/mL
2011-12	31470	II	C48520	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Package Dosing Unit	SY: Package Dosing Unit; Pack Dosing Unit
2011-12	31470	II	C64387	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Millimole per Liter; umol/mL; Micromole per Milliliter; mol/m3; Mole per Cubic Meter	SY: Millimole per Liter; umol/mL; Micromole per Milliliter; mol/m3; Mole per Cubic Meter; mcmol/mL; mmol/L; nmol/uL
2011-12	31470	II	C64566	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Kilogram per Liter; g/mL; Gram per Milliliter	SY: Kilogram per Liter; g/mL; Gram per Milliliter; gram/mL; kg/L; mg/uL
2011-12	P7-P8	II	C64572	Synonym	SDTM-UNIT	Addition of synonym	SY: Gram per Cubic Meter; ug/mL; Microgram per Milliliter; mg/L; Milligram per Liter	Gram per Cubic Meter; ug/mL; Microgram per Milliliter; Milligram per Liter; g/m3
2011-12	31470	II	C64572	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Gram per Cubic Meter; ug/mL; Microgram per Milliliter; mg/L; Milligram per Liter; g/m3	SY: Gram per Cubic Meter; ug/mL; Microgram per Milliliter; mg/L; Milligram per Liter; g/m3; mcg/mL; ng/uL
2011-12	31470	II	C64783	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Gram per Deciliter	SY: Gram per Deciliter; g%
2011-12	31470	II	C67015	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Milligram per Deciliter	SY: Milligram per Deciliter; mg%
2011-12	31474	II	C67069	Synonym	SDTM-UNIT	Addition of synonym in SDTM-UNIT codelist due to use of terms in other codelists.	SY: Per Week	SY: Every week; Per Week
2011-12	31470	II	C67306	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L	SY: mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL
2011-12	P7-P8	II	C68896	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial numbers equal to 10E6 colony forming units.(NCI)	Def: A unit of measurement of viable bacterial numbers equal to 10 to the sixth power colony forming units.
2011-12	31470	II	C67396	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: ug/kg; Microgram per Kilogram	SY: ug/kg; Microgram per Kilogram; ng/g
2011-12	P7-P8	II	C68897	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial numbers equal to 10E9 colony forming units.(NCI)	Def: A unit of measurement of viable bacterial numbers equal to 10 to the ninth power colony forming units.
2011-12	P7-P8	II	C68899	Definition	SDTM-UNIT	Definition update.	"Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of thousand colony forming units (10E3CFU) in one gram of substance.(NCI)
"	Definition: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the third power colony forming units in one gram of substance.
2011-12	P7-P8	II	C68900	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of million colony forming units (10E6CFU) in one gram of substance.(NCI)	Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the sixth power colony forming units in one gram of substance.
2011-12	P7-P8	II	C68901	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of billion colony forming units (10E9CFU) in one gram of substance.(NCI)	Def: A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the ninth power colony forming units in one gram of substance.
2011-12	P7-P8	II	C68903	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of thousand colony forming units (10E3CFU) in one milliliter of substance.(NCI)	Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the third power colony forming units in one milliliter of substance.
2011-12	P7-P8	II	C68904	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of million colony forming units (10E6CFU) in one milliliter of substance.(NCI)	Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the sixth power colony forming units in one milliliter of substance.
2011-12	P7-P8	II	C68905	Definition	SDTM-UNIT	Definition update.	Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of billion colony forming units  (10E9CFU) in one milliliter of substance.(NCI)	Def: A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the ninth power colony forming units in one milliliter of substance.
2011-12	P7-P8	II	C71187	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of quantity of organisms expressed in thousands.(NCI)	Def: A unit of measure of quantity of organisms expressed in 10 to the third power of organisms.
2011-12	P7-P8	II	C71188	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of quantity of organisms expressed in millions.(NCI)	Def: A unit of measure of quantity of organisms expressed in 10 to the sixth power of organisms.
2011-12	P7-P8	II	C71189	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of quantity of organisms expressed in billions.(NCI)	Def: A unit of measure of quantity of organisms expressed in 10 to the ninth power of organisms.
2011-12	P7-P8	II	C71190	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism content expressed in thousands of organisms per unit of mass equal to one gram.(NCI)	Def: A unit of measure of organism content expressed in 10 to the third power of organisms per unit of mass equal to one gram.
2011-12	P7-P8	II	C71191	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism content expressed in millions of organisms per unit of mass equal to one gram.(NCI)	Def: A unit of measure of organism content expressed in 10 to the sixth power of organisms per unit of mass equal to one gram.
2011-12	P7-P8	II	C71192	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism content expressed in billions of organisms per unit of mass equal to one gram.(NCI)	Def: A unit of measure of organism content expressed in 10 to the ninth power of organisms per unit of mass equal to one gram.
2011-12	P7-P8	II	C71193	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism content expressed in millions of organisms per unit of mass equal to one milligram.(NCI)	Def: A unit of measure of organism content expressed in 10 to the sixth power of organisms per unit of mass equal to one milligram.
2011-12	P7-P8	II	C71194	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism content expressed in billions of organisms per unit of mass equal to one milligram.(NCI)	Def: A unit of measure of organism content expressed in 10 to the ninth power of organisms per unit of mass equal to one milligram.
2011-12	P7-P8	II	C71195	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism concentration expressed in thousands of organisms per unit of volume equal to one milliliter.(NCI)	Def: A unit of measure of organism concentration expressed in 10 to the third power of organisms per unit of volume equal to one milliliter.
2011-12	P7-P8	II	C71196	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism concentration expressed in millions of organisms per unit of volume equal to one milliliter.(NCI)	Def: A unit of measure of organism concentration expressed in 10 to the sixth power of organisms per unit of volume equal to one milliliter.
2011-12	P7-P8	II	C71197	Definition	SDTM-UNIT	Definition update.	Def: A unit of measure of organism concentration expressed in billions of organisms per unit of volume equal to one milliliter.(NCI)	Def: A unit of measure of organism concentration expressed in 10 to the ninth power of organisms per unit of volume equal to one milliliter.
2011-12	31470	II	C48153	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Microliter	SY: mcL; Microliter; mm3
2011-12	31470	II	C73755	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Milliliter per Gram per Day	SY: Milliliter per Gram per Day; mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d
2011-12	31470	II	C67306	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Microgram per Liter; mg/m3; Milligram per Cubic Meter; ng/mL; Nanogram per Milliliter; mcg/L	SY: mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL; mcg/L
2011-12	31470	II	C67405	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Micro-International Unit per milliliter	SY: Micro-International Unit per milliliter; mIU/L; mcIU/mL; uIU/mL
2011-12	31470	II	C73760	Synonym	SDTM-UNIT	Addition of synonyms in SDTM-UNIT codelist due to use of terms in SDTM-PKUNIT codelist.	SY: Milliliter per Kilogram per Minute	SY: Milliliter per Kilogram per Minute; uL/g/min; mL/min/kg; uL/min/g; mL/kg/min
2011-12	31428; 31429	II	C84372	Synonym	SDTM-VSTEST; SDTM-VSTESTCD	Change the Synonym to "Knee to Heel Length" for VSTEST='Knee to Heel Length', or at least add "Knee to Heel Length" as the first synonym.	SY: Lower Leg Length	SY: Knee to Heel Length; Lower Leg Length
2011-12	P7-P8	III	C88025	Codelist	SEND-NEOPLASM	Addition of a new Neoplasm codelist for SDTM and SEND.	- - -	Addition of 303 terms to a new codelist.
2011-12	P7-P8	III	MULTIPLE	Submission Values	SEND-SPEC	Addition of new terminology to existing codelist.	See published spreadsheet 2011-07-22	Addition of 11 terms to an existing codelist.
2011-12	P7-P8	III	C18809	Submission Values	SEND-STCAT	Addition of new terminology to existing codelist.	See published spreadsheet 2011-07-22	PT: Genetic Toxicity
2011-12	P7-P8	III	MULTIPLE	Submission Values	SEND-STRAIN	Addition of new terminology to existing codelist.	See published spreadsheet 2011-07-22	Addition of 4 terms to an existing codelist.
2011-12	P7-P8	II	C90462	C-code	SEND-STSPRMCD; SEND-STSPRM	Change of c-code due to change in CDISC SDTM definition.	Code: C90462	Code: C99156
2011-12	P7-P8	II	C69208	C-code	SEND-STSPRMCD; SEND-STSPRM	Change of c-code due to change in CDISC SDTM definition.	Code: C69208	Code: C99157