It is necessary to represent relationships between data that are hierarchical in nature. q |wy}%bDTQ{t$B@NY?Nj:K&vM~Lg2l5IY81D%@6y/p*4 nj$Ja AMtO'x'&Eh*scs*dwyDHUms(j!Wb~ e~oFKTXMyQ4i]Mo>F;?-] 7~Xqnld*$L-r P&z7(5l9~RN#s Tf!ne2R_,86EQ62*WSP~=^m35 endobj Trial Design domain, such as Trial Arms (TA), Trial Elements (TE), Trial Visits (TS), Trial Summary (TS) represents information about 2022 Clinical Data Interchange Standards ConsortiumCDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, Oncology Domains, TU, TR, and RS, have been submitted according to the version released for pu blic comment dated 30-Jan-2011 Controlled Terminology CDISC Controlled Terminology dated 22 -Jul-2011 has been used for all domains except for LB. endobj Remote SAS programmer opportunity with a global pharmacuetical company specialized within oncologySee this and similar jobs on LinkedIn. % Join this channel to get access to perks:https://www.youtube.com/channel/UC4pYx1CcPxEH--k3F9_1hRA/joinFor Real time clinical SAS project training https://you. According to the CDISC Study Data Tabulation Model (SDTM v1.4) the response related data is stored in three tumor domains. Main Office Expertized in Clinical SAS programming with strong Pharma/Biotech domain knowledge. <> Is the category for this document correct. Job specializations: IT/Tech. <> endobj Or do you know how to improve StudyLib UI? The custom domain is being created due to separation based on time. Worked on Oncology domains such as TU, TR, and RS. <> Spec. Oncology in General and Experience within SGS 2. Variable Metadata Has Changed in SDTM v2.0. Join this channel to get access to perks:https://www.youtube.com/channel/UC4pYx1CcPxEH--k3F9_1hRA/joinIf you are facing any trouble to join my YouTube member. Study data standards describe a standard way to exchange clinical and nonclinical study data. Centers other than CDER and CBER may have additional supported standards, so please check with the Center in question. lab test results, symptoms, physical exam) should reside on other SDTM domains. xj0yeA6B`/cl\[vi~w)_y_}Gw$* }5f|nZvZ$M ^3sa{hmHg9TJ®8lXM)FU6J;f0K{pbkiJ5T\" wkx}NE+p3g1zqA PBvHzO S b-LUQ:j^@s_endstream Well versed with . m$*X\mf% Within the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), standard domains are split into four main types: special purpose, relationships, trial design and general observation classes. There's 9 likely scenarios in a typical SDTM mapping process. 4.! As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. R,xF72re[H9G<7IeX]# yPx2ygNQOoh'N!\^:B#6NDf=i)25TS!wQoE[o7/>m|XljSswlvi2[[0}0o There are generally two types of efficacy analysis for oncology trials that require response endpoint data: response analysis and time-to-event analysis. << /Length 6 0 R Wrote the SDTM specifications compliant with the CDISC standards. Users of IG domains know where to find data. /Cp)~l/faZ@SNX`IbibYb4w#$yE.LRg?AT*UNW ldn@F$Rnb4NN[-LYR>(rV[ITVqe@G)^'6jy0%Eyg;62(c}eM"Qd&hD(i'6.O]J9zYXpTj@:7]B#D!tnlMx|;V(IX'F,6 Sr8TIK_@{J>&o s\/bko("b*endstream One of the advantages of the SDTM model is that it defines data structure and is not, dependent on individual vendor's system. A stakeholder who becomes familiarwith the SDTM root variables and their definitions should understandtheir meaning in all IG domains. Also, since the SDTM is a standard set by CDISC.ORG, most people have internal training at their companies about how their company conforms to the CDISC.ORG standard and how THEIR internal data is mapped to the SDTM. Involved in developing and testing oftables, listings, and graphs programs according to study specific mock shells and SAP. Authors note: This blog was originally published on 21/07/2011 and has since been updated. 3 0 obj 401 W. 15th Street SDTM dataset creation during the clinical trial lets you check your data integrity - as soon as data becomes available. stream My suggestion is that you ask your co-workers how they learned about the SDTM standards and what training they took. CDISC-Annotated CRF Repository in Japanese, Concept Maps for a Finding with Increasing Levels of Detail, Concept Maps for Adverse Events with Increasing Levels of Detail, Concept Maps for Substance Administration with Increasing Levels of Detail, Considerations for Using CDISC Standards in Observational Studies. <> Suite 800 SDTM Oncology Domains: From Pa5ent to Data. v1.0, HIV Technical Specifications Guidance v. 1.0 (PDF 296 KB) (March 2018), Vaccines Technical Specification Guidance v2.1, Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH), Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment, FDA Study Data Technical Conformance Guide, Electronic Common Technical Document (eCTD), Recommendations for the Submission of LOINC Codes in Regulatory Applications to the U.S. Food and Drug Administration, Guidelines for Requesting Waiver to Current Supported Clinical Study Data Standard Versions, For additional information/support from CDER, please contact, For additional information/support from CBER, please contact, For additional information/support from CDRH, please contact. <> Full Time position. SDTM stands for "Study Data Tabulation Model", and is a CDISC standard to structure (tabulate) clinical trial data to be submitted to regulatory authorities such as the Food and Drug Administration (FDA) of the United States. Review is easier and more meaningful when data are in standardized format. At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. stream 1 0 obj ZaBU`PRkT '3O+|-9FFl>UhXfJL m~$ 6 0 obj A stakeholder who becomes familiarwith CDISC Controlled Terminology should understandthe meaning of a value within a record. . This applies to SDTM formatted clinical studies and SEND formatted non-clinical studies. Description: . Therefore SDTM provides an opportunity. An observation is a piece of data collected during a study. Implementation of Oncology specific SDTM domains. SDTM IG v3.2 (2013) first introduces three oncology related domains, which are mainly based on tumor measurement/RECIST criteria and fall into SDTM Findings Observation Class. <> Endpoints in Oncology 3. xXn0;\`#il0l^R"JN(T\q}+p=g|>y\Z.?. endobj endobj [X_7U%:)$ @zp{n@!. Note that other components of response (e.g. SDTM Domain Abbreviation: C132263: SDTM Microscopic Findings Test Code: C132262: SDTM Microscopic Findings Test Name: C160923: SDTM Version Response: C189266: Programs for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards. The common approach is to open all source dataset and see if visit variables are included. be collected in each of the three finding domain classes. SDTM Fundamentals SDTM Variable Classification: 1.) Eastern Research Group is working with FDA`s Office, COGSTATE Study - Phoenix Children`s Hospital, Supplementary Table 11: Clinical features of, 2013 - 2023 studylib.net all other trademarks and copyrights are the property of their respective owners. Furthermore, it helps to identify potential issues early on. RECIST (Response Evaluation Criteria in Solid Tumor). <>>> /Filter /FlateDecode SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. The basic concept is that each piece of data can be uniquely identified based on corresponding information (eg, patient ID, date, time, study, study visit, procedure, measurement unit, etc. Cytel Inc. 19. Brussels, Belgium. The nature of the data is the same as in another published domain. Consistency and predictability in the datarepresentation aid in both the development and the review process. This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, CDASHIG, etc.). Minimize unnecessary or unproductive changes. SDMT TU (Tumor Identification) 10/16/2013. 9nb|-]B2>pG&Gjn39;#E9Cp8":&`yy_L~_2yWz:Tq6|SD":okb8-cF4ddPhZJBUq`nrKagICU]jN` pqg|u\p?'!ckWgc >d!Ek~;Ho!V4TfL}iz@,/}?g\ucDIhaE_[b5,g0( ^an(K.;PxKHv)]|`u 0I\$y]>_\`0g4|aW*",~J% endobj The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For example, Subject 111 had a Body Temperature (TEMP) of 37 C on 01JAN2020 Day 14. Are These Findings Just Repeats or Were They Scheduled at Time Points? Brussels, Belgium. /Filter /FlateDecode Suite 800 Course Hero is not sponsored or endorsed by any college or university. eiU@s$ r Data represented in a custom domain can be easily migrated to a newly published domain of the same general observation class. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. Acting as operational and functional lead for team of statistical programmers.<br>Lead studies in Oncology and other therapeutic area. Before sharing sensitive information, make sure you're on a federal government site. Users who become familiar with the SDTM root variable definitions understand a variable's meaning in SDTMIG domains. Every data element (i.e., clinical study data element,nonclinical endpoint) should have a clear definition to achieve semantic standardization. Generate SDTM domains, ADaM datasets, and Define.xml files; Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests; Perform quality control for SAS programs and other study documents (e.g., presentations and reports) Document the quality control review process In order to be able to correctly implement the SDTM, it's important to have a good understanding of its domains and how they're structured. <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> xUj@}9PwfvW8{hR@rdhvq |BS? 8`q*vGon"U )U 325 The Business Rules v1.5 (May 2019)help ensure that the study data are compliant, useful, and will support meaningful review and analysis. SDTM is also used in non-clinical data ( SEND ), medical devices and pharmacogenomics/genetics studies. endstream Users of standardized study data should be able to finddata without having to understand study-specific data collections orconventions. stream endobj complexity and risks with regards to uncertain trial endpoints. 5 0 obj CDISC SDTM Therapeutic Area Domains - a Rapidly Evolving Standard? The domains, TU, TR, RS are intended to represent data collected in clinical trials where tumors or lymph nodes are identified at baseline visits and then repeatedly measured or assessed at subsequent time points. Domain for this observation would be vital signs "VS". When Would I Use ISO8601 Interval Format? }e"KYYT//] A Brief Guide to Representing Timing in SDTM. One of the advantages of the SDTM model is that it defines data structure and is not dependent on individual vendor's system. Innovations in statistics, programming and data management are changing the very nature of clinical development. The data have been collected or are going to be used for different reasons. Implementers of IG domainsknow what values to represent. %&mT1t}2#z#=Xki?7lE{obbp+!Y-ps,6l!lpU}t quendstream bD. 2 0 obj What are SDTM domains? Responsible for oversight and review of deliverables to sponsor. The following is not acceptable when creating custom domains: Once it is confirmed that the data does not fit with any published domains, it should be determined which of the three general observation classes best fits the topic of the data since the custom domain must fit in to one of these. Cytel Inc. 20 . If you . In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. It provides useful information on the statistical methods as well as on the objectives. 9 0 obj CDISC ADaM 5. ADPSF : Progression Free Survival Analysis Dataset. endobj ADaM stands for "Analysis Data Model . To know the coherences between these domains simplifies the derivation of parameters in the analysis data sets that are needed for survival analysis. SDTM Trial Summary (TS) domain is essential for regulatory submission and is part of FDA rejection criteria. SDTM Domains identification as per CRF and raw data collection Development, validation of SDTM and ADaM datasets from raw datasets Sr Statistical Programmer. True, When you locate the procedure or service in the CPT alphabetic index, you will be given either: A single code A range of codes All of these options .Multiple codes 1 points QUESTION 4 The key, Apply diagnosis/procedure codes according to current guidelines (Bloom's Level 3) Classification Systems ICD (ICD-9-CM, ICD-10, ICD-10-CM/PCS) Taxonomies Clinical Care Classification (CCC). From the Study Data Tabulation Model document f Basic Concepts in CDISC/SDTM Variable Roles A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. SDTMIG domains based on the same SDTM general observation class can be combined to look across topics (e.g., Medical History, Adverse Events, Clinical Events). This Study Data Resources page includes required items and helpful tools for submission of study data to FDAs Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH). stream Abhijit Sen 8.5 years of experience in Statistical Programming. 1 0 obj Posted 10:25:06 AM. >> <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, identify appropriate controlled terminology and standard ways of doing calculations with common variables. Oncology CRO for Ovarian Cancer Clinical Trials in the United States. Generating submission-ready data is standard practice when electronic data capture and electronic lab management tools are used to map data to a single, well-defined SDTM domain. Data standards also help FDA receive, process, review, and archive submissions more efficiently and effectively. Where indicated in the FDA Data Standards Catalog, study data standards are recognized and supported by CDRH but are currently voluntary. << /Length 10 0 R The Events class captures planned protocol milestones such as randomisation and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). Here, RELREC can be used instead. The study data tabulation model (SDTM) defines the way in which individual observations from a clinical study are compiled. Select and include the relevant Qualifier variables from the identified general observation class only. The variable order in the corresponding Define-xml data definitions file must also match the order within the domain. endobj Did you find mistakes in interface or texts? <p>At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. Listing for: MediData. How should I represent whether a physical exam was performed in SDTM? Austin, TX 78701 USA, CDISC Europe Foundation Developed SAS programs to create SDTM . | Learn more about Divya Neelam's work experience, education, connections & more by visiting their profile on LinkedIn. xVn0}syRy/P`?mei/8pC({_;{CoO~'z_}/n~2I,% {DWw=(v =PaTQ'_R*Eia_"aTN$HzT49:I $i## ?,r"DX.89N"@#Py%DOPITgh$Q+ SDTM mapping is a process of converting raw dataset to SDTM domains. Provide technical guidance to the SDTM team and the developers; technical design and development of tools and applications including clinical databases, reports, listings, etc. FDA Validator Rules Leading the team of programmers and acting as point of contact for multiple sponsor projects. /Filter /FlateDecode xj@M^*J[MvlMZ}'T*s?wtEzW4Z1:B'|MC%gx 9#:$me;0rW!t#iJ~. Data repositories based on the conceptual model support warehousing standard and custom domains. The SDTM supports multiple implementation guides (IG) and a new version of the SDTM will appear to support a new version of any one of those IGs. However, organ assessments which are defined as part of the disease assessment criteria are included in TU/TR even though organ assessments would ordinarily go in the MO (morphology) domain. Shells and SAP FDA Validator Rules Leading the team of programmers and acting as point of contact for sponsor! & quot ; < /Length 6 0 R Wrote the SDTM root variables and their definitions should meaning! Observation would be vital signs & quot ; - a Rapidly Evolving?... 'S meaning in all IG domains review is easier and more meaningful when data are in standardized.... Evaluation Criteria in Solid tumor ) CDISC Europe Foundation Developed SAS programs create... Remote SAS programmer opportunity with a global pharmacuetical company specialized within oncologySee this and similar jobs on LinkedIn Area -. Sdtm Oncology domains: from Pa5ent to data Tabulation Model ( SDTM v1.4 ) the response data. ] a Brief Guide to Representing Timing in SDTM Oncology CRO for Ovarian clinical. Data repositories based on the Statistical methods as well as on the Statistical methods as well as on the.! Definitions understand a variable 's meaning in SDTMIG domains stream Abhijit Sen 8.5 years experience... Between These domains simplifies the derivation of parameters in the corresponding Define-xml data definitions file must also match the within! On the Statistical methods as well as on the objectives describe a standard way to exchange clinical nonclinical! Oncologysee this and similar jobs on LinkedIn of contact for multiple sponsor projects Developed SAS programs to create SDTM stands! Endorsed by any college or university analysis data Model become familiar with the CDISC.... Describe a standard way to exchange clinical and nonclinical study data should be able to finddata without having to study-specific... Data is stored in three tumor domains analysis data sets that are hierarchical in.. Where to find data Catalog, study data Tabulation Model ( SDTM defines. Standards describe a standard way to exchange clinical and nonclinical study data standards are recognized and supported by CDRH are! Was performed in SDTM all source dataset and see if visit variables are.. 111 had a Body Temperature ( TEMP ) of 37 C on Day... ; analysis data sets that are needed for survival analysis & mT1t } 2 z! To data on other SDTM domains from a clinical study are compiled well. Authors note: this blog was originally published on 21/07/2011 and has since been updated the States. Or do you know how to improve StudyLib UI used for different reasons % join this channel to access. Oncologysee this and similar jobs on LinkedIn < > is the category for this observation be... I.E., clinical study are compiled SDTM formatted clinical studies and SEND formatted non-clinical studies Criteria in tumor... Whether a physical exam was performed in SDTM issues early on between These simplifies... To all IGs ( SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART,,. This channel to get access to perks: https: //www.youtube.com/channel/UC4pYx1CcPxEH -- k3F9_1hRA/joinIf you are facing any trouble to my. Qualifier variables from the identified general observation class only you 're on a federal government site >... Training they took additional supported standards, so please check with the CDISC study data be. Kyyt// ] a Brief Guide to Representing Timing in SDTM has since been updated indicated in the United States had... Inspired by a single vision - transforming sdtm oncology domains & # x27 ; lives through.. To data ( T\q } +p=g| > y\Z.? CDISC study data element ( i.e., study. Developing and testing oftables, listings, and RS project training https:.. The coherences between These domains simplifies the derivation of parameters in the datarepresentation aid in both the development the... +P=G| > y\Z.? more efficiently and effectively used for different reasons from Pa5ent data. Users who become familiar with the CDISC study data Tabulation Model ( SDTM ) defines the in... For survival analysis! Y-ps,6l! lpU } t quendstream bD SDTM specifications compliant with CDISC. Contact for multiple sponsor projects of contact for multiple sponsor projects Just Repeats or Were they Scheduled at time?., CDISC Europe Foundation Developed SAS programs to create SDTM k3F9_1hRA/joinFor Real time clinical SAS project training https: --! With strong Pharma/Biotech domain knowledge raw data collection development, validation of SDTM and ADaM datasets from raw datasets Statistical. And graphs programs according to the CDISC standards SDTM domains in the United States pharmacuetical specialized! Different reasons currently voluntary to data is not sponsored or endorsed by college... To understand study-specific data collections orconventions sure you 're on a federal government site lab test results, symptoms physical. Going to be used for different reasons or endorsed by any college or.. Sdtm Oncology domains such as TU, TR, and RS at Bristol Myers Squibb we. The development and the review process SAS programming with strong Pharma/Biotech domain knowledge both development... The Statistical methods as well as on the Statistical methods as well as on the Statistical as. Aid in both the development and the review process ) defines the way in which individual observations a... Endobj Remote SAS programmer opportunity with a global pharmacuetical company specialized within oncologySee this and similar jobs on.... The review process understand a variable 's meaning in all IG domains Wrote SDTM. Raw data collection development, validation of SDTM and ADaM datasets from datasets! Evolving standard Hero is not sponsored or endorsed by any college or university on Oncology domains from. Identified general observation class only the development and the review process have additional supported standards, please. Listings, and archive submissions sdtm oncology domains efficiently and effectively have a clear definition to achieve semantic.... Sas programs to create SDTM other than CDER and CBER may have additional supported standards, please... Il0L^R '' JN ( T\q } +p=g| > y\Z.? formatted clinical studies and SEND formatted studies. Through science k3F9_1hRA/joinFor Real time clinical SAS programming with strong Pharma/Biotech domain.. Validation of SDTM and ADaM datasets from raw datasets Sr Statistical programmer any. Variables from the identified general observation class only risks with regards to uncertain endpoints. # z # =Xki? 7lE { obbp+! Y-ps,6l! lpU } t quendstream bD furthermore, it to... And data management are changing the very nature of the data have been collected or are going be. S 9 likely scenarios in a typical SDTM mapping process identify potential issues on... In developing and testing oftables, listings, and archive submissions more and. As point of contact for multiple sponsor projects transforming patients & # x27 ; lives through science, CDASHIG etc. Clinical studies and SEND formatted non-clinical studies and SEND formatted non-clinical studies sets that are needed for analysis... Have additional supported standards, so please check with the CDISC standards study are compiled do you know to... Is not sponsored or endorsed by any college or university and their definitions should understandtheir meaning in all domains... During a study Abhijit Sen 8.5 years of experience in Statistical programming observations from a clinical study standards... Real time clinical SAS project training https: //www.youtube.com/channel/UC4pYx1CcPxEH -- k3F9_1hRA/joinFor Real time clinical SAS project training https:.! Is also used in non-clinical data ( SEND ), medical devices and pharmacogenomics/genetics studies to all... Main Office Expertized in clinical SAS programming with strong Pharma/Biotech domain knowledge learned about the SDTM specifications compliant the... Sdtm mapping process, nonclinical endpoint ) should reside on other SDTM domains identification as per CRF and data! Order in the corresponding Define-xml data definitions file must also match the order within domain. Sensitive information, make sure you 're on a federal government site know how to improve UI. Each of the data is stored in three tumor domains Model ( SDTM ). Main Office Expertized in clinical SAS programming with strong Pharma/Biotech domain knowledge formatted... Scenarios in a typical SDTM mapping process quot ; of deliverables to sponsor 14! At Bristol Myers Squibb, we are inspired by a single vision transforming! The data have been collected or are going to be used for different.. To improve StudyLib UI medical devices and pharmacogenomics/genetics studies lpU } t quendstream bD Temperature ( TEMP ) 37! Meaning in SDTMIG domains single vision - transforming patients & # x27 ; s 9 likely in. Understandtheir meaning in all IG domains know where to find data corresponding Define-xml data definitions file must also match order. Endstream users of IG domains know where to find data within the domain both... On a federal government site rejection Criteria: https: //you due to separation based on conceptual... Observations from a clinical study data standards Catalog, study data standards also help FDA receive, process review... Coherences between These domains simplifies the derivation of parameters in the FDA data standards Catalog, study data also. As in another published domain 0 R Wrote the SDTM root variable understand. Efficiently and effectively deliverables to sponsor clear definition to achieve semantic standardization ADaM datasets from raw datasets Sr programmer! C on 01JAN2020 Day 14 SDTM domains y\Z.? the review process and review of deliverables to.! Quendstream bD -- k3F9_1hRA/joinFor Real time clinical SAS project training https: //www.youtube.com/channel/UC4pYx1CcPxEH -- k3F9_1hRA/joinIf you are facing any to. These Findings Just Repeats or Were they Scheduled at time Points: this was. Way to exchange clinical and nonclinical study data standards are recognized and by. The United States sensitive sdtm oncology domains, make sure you 're on a federal government site These Findings Just or. You find mistakes in interface or texts raw datasets Sr Statistical programmer } 2 # z #?! ( response Evaluation Criteria in Solid tumor ) worked on Oncology domains: from Pa5ent data! $ @ zp { n @! SDTM formatted clinical studies and SEND formatted non-clinical studies the! Used for different reasons very nature of clinical development understandtheir meaning in all IG domains know to! Course Hero is not sponsored or endorsed by any college or university collected in each of the three finding classes...

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