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Warning Text %XTableStyleMedium9PivotStyleLight16`ÂReadMe$CDASH Terminology 2012-12-21!  ;bZ    3 A@@   PuffMilliliters per MinuteUnit of Measure for Flow RateMinute Unit of TimeSupinemcmol/day; Micromoles per Day As Needed Every MonthEvery other day4 times per day3 times per daycm3; MilliliterMicrogram; mcg%Pack Dosing Unit; Package Dosing UnitCode Codelist CodeCodelist Extensible (Yes/No) Codelist NameC78417YesCMDOSUC28253mgC48152ugC28254mLC48155gC48579IUC48542TABLETtabC48480CAPSULEcapC65060PUFFC78418 Concomitant Medication Dose FormCMDOSFRMC42998C25158C42966OINTMENTointC42993 SUPPOSITORYsuppC42887AEROSOLaerC42989SPRAYC42994 SUSPENSIONsuspC42968PATCHC42933GASC42934GELC28944CREAMC42972POWDERC784194Concomitant Medication Dosing Frequency per IntervalCMDOSFRQC64496BIDC64527TIDC64530QIDC64525QODC64498QMC64499PRNC17998UNKNOWNC78420.Concomitant Medication Route of AdministrationCMROUTEC38288ORALC38304TOPICALTOPC38299 SUBCUTANEOUSSCC38305 TRANSDERMALC38255 INTRAOCULARC28161 INTRAMUSCULARC38216C38250C38258C38284NASALC38313VAGINALC38295RECTALC78421"Unit of Drug Dispensed or ReturnedDAORRESUC48474BAGC48477BOTTLEC48478BOXC48484 CONTAINERC48490DISKC48520PACKAGEC48521PACKETC48524C48549TUBEC48551VIALC78422ECG Original UnitsEGORRESUC41140msecC42535secC49673 BEATS/MINC78423Units for ExposureEXDOSUC78745&Exposure Dosing Frequency per IntervalEXDOSFRQC78425 Exposure Route of AdministrationEXROUTEC78426Exposure Dose FormEXDOSFRMC78427/Unit for the Duration of Treatment InterruptionEXINTPUC48154minC25529HOURSC78428 Total Volume Administration UnitEXVOLTUC78429EXFLRTUC71211ug/minC71205ug/dayC64777mL/minC67420mmol/dayC67406umol/dayC78430Units for Planned ExposureEXPDOSEUC78431Vital Signs Position of SubjectVSPOSC62122SITTINGC62166STANDINGC62167SUPINENCI Preferred TermThe unit of mass equal to one thousandth of a gram or 1000 micrograms. One milligram equals approximately 0.015432 grain or 35.274 x 10E-6 ounce.(NCI) MilligramThe unit of volume equal to one thousandth of a liter, one cubic centimeter, 10E-6 cubic meter, or approximately to 0.061 023 7 cubic inch.(NCI) MilliliterVA unit of mass equal to one millionth of a gram or one thousandth of a milligram.(NCI) MicrogramFA metric unit of mass equal to one one thousandth of a kilogram. (NCI)Gram4A dosing measurement based on the capsule unit.(NCI)Capsule Dosing Unit3A dosing measurement based on the tablet unit.(NCI)Tablet Dosing Unit5The unitage assigned by the WHO (World Health Organization) to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization (e.g. hormones, enzymes, and vaccines), to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae.(NCI)A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI)Puff Dosing Unit8CDISC CDASH Concomitant Medication Dose Form TerminologyA solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI)tA semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI)KA product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). (NCI)Aerosol Dosage FormkAny elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI)Gas Dosage FormGel Dosage FormOintment Dosage FormPatch Dosage FormzAn intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI)Powder Dosage Form<A liquid minutely divided as by a jet of air or steam. (NCI)Spray Dosage FormA solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. (NCI)Suppository Dosage FormA liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (FDA)Suspension Dosage Form\A solid dosage form containing medicinal substances with or without suitable diluents. (NCI)Tablet Dosage FormLCDISC CDASH Concomitant Medication Dosing Frequency per Interval Terminology8Not known, not observed, not recorded, or refused. (NCI)Unknown.Two times per day, at unspecified times. (NCI) Twice DailyEvery month. (NCI)MonthlyAs needed. (NCI) As NecessaryEvery other day. (NCI)Every Other DayThree times per day. (NCI)Three Times DailyFour times per day. (NCI)Four Times DailyFCDISC CDASH Concomitant Medication Route of Administration Terminology*Intralesional Route of Drug Administration(Intraocular Route of Drug Administration,Intraperitoneal Route of Drug Administration"Nasal Route of Drug Administration!Oral Route of Drug administration#Rectal Route of Drug Administration)Subcutaneous Route of Drug Administration$Topical Route of Drug Administration(Transdermal Route of Drug Administration$Vaginal Route of Drug Administration:CDISC CDASH Unit of Drug Dispensed or Returned Terminology0A dosing measurement based on the bag unit.(NCI)Bag Dosing Unit3A dosing measurement based on the bottle unit.(NCI)Bottle Dosing Unit0A dosing measurement based on the box unit.(NCI)Box Dosing Unit6A dosing measurement based on the container unit.(NCI)Container Dosing Unit1A dosing measurement based on the disk unit.(NCI)Disk Dosing Unit4A dosing measurement based on the package unit.(NCI)Package Dosing Unit3A dosing measurement based on the packet unit.(NCI)Packet Dosing Unit2A dosing measurement based on the patch unit.(NCI)Patch Dosing Unit1A dosing measurement based on the tube unit.(NCI)Tube Dosing Unit1A dosing measurement based on the vial unit.(NCI)Vial Dosing Unit*CDISC CDASH ECG Original Units TerminologyBA unit of time, which is equal to one thousandth of a second.(NCI) MillisecondThe second is a unit of time with a duration of 919 263 177 0 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. According to the convention, 60 seconds constitute one minute; 3,600 seconds constitute one hour. Abbreviation Sec. is acceptable in non-scientific usage only.(NCI)Beats per Minute*CDISC CDASH Units for Exposure Terminology>CDISC CDASH Exposure Dosing Frequency per Interval Terminology8CDISC CDASH Exposure Route of Administration Terminology*CDISC CDASH Exposure Dose Form TerminologyCCDISC CDASH Unit for Duration of Treatment Interruption TerminologylA unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI)Hour0A unit measure of time equal to 60 seconds.(NCI)Minute8CDISC CDASH Total< Volume Administration Unit Terminology5CDISC CDASH Unit of Measure for Flow Rate TerminologyA metric unit of volumetric flow rate defined as the rate at which one milliliter of matter travels during the period of time equal to one minute.(NCI)Milliliter per MinuteA unit of amount of substance flow rate equivalent to the rate at which one millionth of a mole of substance travels to a given object or space over a period of time equal to 24 hours.(NCI)Micromole per 24 HoursA unit of amount of substance flow rate equivalent to the rate at which one thousandth of a mole of substance travels or is delivered to a given object or space over a period of time equal to 24 hours.(NCI)Millimole per 24 HourskA unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to twenty four hours. Microgram per day is also a dose administration rate unit equal to the rate at which one millionth of a gram of a product is administered per unit of time equal to twenty four hours.(NCI)Microgram per Day`A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to one minute. Microgram per minute is also a dose administration rate unit equal to the rate at which one millionth of a gram of a product is administered per unit of time equal to one minute.(NCI)Microgram per Minute2CDISC CDASH Units for Planned Exposure Terminology7CDISC CDASH Vital Signs Position of Subject TerminologyOThe state or act of one who sits; the posture of one who occupies a seat. (NCI)SittingCThe act of assuming or maintaining an erect upright position. (NCI)_A posterior recumbent body position whereby the person lies on its back and faces upward. (NCI)Supine PositionSA suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. (NCI)Capsule Dosage FormCream Dosage Form%Intramuscular Route of AdministrationColumn DescriptionCode (Column A)Codelist Code (Column B)(Codelist Extensible (Yes/No) (Column C) 'A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Concomitant Medication Dose Form codelist. (NCI)xA terminology subset of the CDISC SDTM Unit codelist created for CDASH Concomitant Medication Dose Units codelist. (NCI)A terminology subset of the CDISC SDTM Frequency codelist created for CDASH Concomitant Medication Dosing Frequency per Interval codelist. (NCI)A terminology subset of the CDISC SDTM Route codelist created for CDASH Concomitant Medication Route of Administration codelist. (NCI)iA terminology subset of the CDISC SDTM Unit codelist created for CDASH ECG Original Units codelist. (NCI)yA terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Drug Dispensed or Returned codelist. (NCI)iA terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Exposure codelist. (NCI)A terminology subset of the CDISC SDTM Frequency codelist created for CDASH Exposure Dosing Frequency per Interval codelist. (NCI)xA terminology subset of the CDISC SDTM Route codelist created for CDASH Exposure Route of Administration codelist. (NCI)A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Exposure Dose Form codelist. (NCI)A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit for Duration of Treatment Interruption codelist. (NCI)wA terminology subset of the CDISC SDTM Unit codelist created for CDASH Total Volume Administration Unit codelist. (NCI)tA terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Measure for Flow Rate codelist. (NCI)qA terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Planned Exposure codelist. (NCI)zA terminology subset of the CDISC SDTM Position codelist created for CDASH Vital Signs Position of Subject codelist. (NCI)A terminology subset of the CDISC SDTM Never/Current/Former Classification codelist created for CDASH Substance Use Never/Current/Former Classification codelist. (NCI)yDefines if controlled terms may be added to the codelist. New terms may be added to existing codelist values as long as they are not duplicates or synonyms of existing terms. The expectation is that sponsors will use the published controlled terminology as a standard baseline and codelists defined as  extensible (or "Yes") may have terms added by the sponsor internally. Codelist Name (Column D)!Concomitant Medication Dose Units9CDISC CDASH Concomitant Medication Dose Units TerminologyThis identifies the CDISC definition for a particular term. The source for a definition is noted in parentheses (e.g. NCI, CDISC glossary, FDA).  INTRALESIONALCDISC Definition (Column G) NCI Preferred Term (Column H)%Unique numeric code assigned to the CDASH parent codelist subset names. This code is repeated for each controlled term (aka preferred term) belonging to a codelist. **NOTE - light blue highlighting is used to identify the beginning of a new CDASH codelist subset and its applicable term set. .Administration to or by way of the mouth.(FDA)Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.(FDA)UAdministration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.(FDA)bAdministration through the dermal layer of the skin to the systemic circulation by diffusion.(FDA)#Administration within the eye.(FDA)$Administration within a muscle.(FDA)JAdministration within or introduced directly into a localized lesion.(FDA)1Administration within the peritoneal cavity.(FDA)AAdministration to the nose; administered by way of the nose.(FDA)$Administration into the vagina.(FDA)"Administration to the rectum.(FDA)CDISC DefinitionContains the descriptive name of the CDASH parent codelist subset. As with the Codelist Code, the Codelist Name is repeated for each controlled term belonging to a codelist.;AhUnique numeric code generated by NCI Thesaurus (NCIt) and assigned to individual CDISC controlled terms.QDSUNCFNEVERCURRENTFORMERPrevious!Not ever; at no time in the past.Never4Occurring in or belonging to the present time. (NCI)Current(Occurring prior to something else. (NCI)C70543C25471C256271Substance Use Never/Current/Former ClassificationICDISC CDASH Substance Use Never/Current/Former Classification TerminologyRESPIRATORY (INHALATION)"Inhalation Route of AdministrationlAdministration within the respiratory tract by inhaling orally or nasally for local or systemic effect.(FDA)Daily!Occurring or done each day. (NCI)C25473C83004International UnitSecondStandingBD; Twice per DayThe controlled terminology in this spreadsheet is contained in Appendix A of the Clinical Data Acquisition Standards Harmonization Standard Version 1.0 (CDASH STDv1.0). Appendix A includes subsets of SDTM controlled terminology codelists for selected CDASH data collection fields. The purpose of the commonly used CDISC Controlled Terminolog<V y appendix A of the CDASH STDv1.0 is to provide frequently used terms from the CDISC SDTM controlled terminology codelists for a number of data collection fields, as an aid for CDASH implementers. Commonly used terms are available for the following domains: CM, DA, EG, EX, VS. However, the full SDTM controlled terminology codelists are also available for CDASH usage.,This identifies the NCI preferred name for a term as identified in NCIt. **NOTE - This column designates the human readable, fully specified preferred term corresponding to the NCI c-code, and is especially helpful for searching NCIt to get the entire concept with links to all instances of the term.CDISC Synonym(s) (Column F)CDISC Submission ValueCDISC Synonym(s)!CDISC Submission Value (Column E) IMPORTANT COLUMN: This is the CDISC preferred name for a term as identified in the NCIt environment and to which numeric codes (Column A) are assigned. Currently (as per SDTMIG 3.1.2) this is the specific value expected for submissions.  Capsule Dosing Unit; capTablet Dosing Unit; tabMicrogram per Day; mcg/dayMicrograms per Minute; mcg/min U; UnknownHour; hrTwice per day; BD8The number of heartbeats measured per minute time. (NCI)INTRAPERITONEALA drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. (NCI)A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. (NCI)%PO; Intraoral Route of Administration"Intranasal Route of AdministrationThe CDASH synonyms column contains standard medical abbreviations that are commonly used in medical records (source documents) and on paper case report forms (CRFs). These correspond to CDASH abbreviations in Appendix A of the CDASH STD v1.0. When commonly used medical abbreviations are not available, this is indicated by dashes ( - - - ) in the CDASH synonyms column. These are the applicable synonyms for the CDISC Submission Value in Column E. 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