sdtm oncology domains

2 0 obj stream SDTM is based on the observations that are collected from subjects taking part in a clinical trial. 1 0 obj x=n78X& 0`rwl,}fmv49_Vbwus4S$Wn}9g?~9zq?vz_m_^>^}oTtTV*M]e^++x~[_O'Q*Gf>N001v6o+#*flQE5N~9DyuEg]20ye2z@OvU@Ge^}tH"oL(wt7@8L67m`Tn>j{`P*S&3:7)s()UQu77)PHiTe4;[W6~Sk M r8nKDX{\ }cq ][=~oE>\E( e6Mdi~Oq5|c.,6UBmtTu]n jT5a-dH`%f*V6qV~xM/3jE:\XXVZJ@:7kypVkBgF#j-G$~ >> 6 0 obj SDTM Domains identification as per CRF and raw data collection Development, validation of SDTM and ADaM datasets from raw datasets TAUG Examples of SDTM Domains Therapeutic Area User Guides contain many useful examples, but it can be hard to find a useful example since there are over thirty TAUGs, and many TAUGs include examples that are useful outside a particular therapeutic area. At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. Job in New York City - Richmond County - NY New York - USA , 10261. Roll Wolfgang2017- Excellent Response to 177Lu-PSMA-61.pdf, ADVANCE-CDM-User-Manual-and-Data-Dictionary-v3.1-20180521.pdf, Monotheistic_Religions_WH_LaniyaLouis..pdf, Which keyword is used to prevent any changes in the variable within a C program, Axelsson O 1977 Solution of linear systems of equations Iterative methods In, dividing into the right and left common iliac arteries Hence it is described in, Technology related problems include which of the following options A, Figure 12 3 Plan Procurement Management Data Flow Diagram Plan Procurement, PHYS1160 Best Discussion Contributions.pdf, Lab 4 - Projectile Motion Data Table.xlsx, Chapter 25 GMM estimation 242 Listing 255 Estimation of the Consumption Based, This paper is organized as follows Section 2 presents the related work Section 3, Full fare economy tickets are fully refundable and flights may be changed at no, 1 points QUESTION 24 The consequences of incomplete or missing documentation include all of the following EXCEPT: Reduces denials and rejections Effects the continuity of patient care Increased, Coding with integrity involves the following aspects EXCEPT: Understanding the legal aspects of coding Understanding coding ethics Understanding and applying Official Coding Guidelines Understanding, Imaging Patient Case Number: IMG04-Thompson, Cannon Patient Name: Cannon Thompson DOB: 06-01-79 Sonographer: Jenny Mills Gender: M Interpreting Physician: Charles Hanes, MD Date of Service: 09-09-XX, The Clinical Documentation Specialist (CDS) ensures that the occurrences of the patient encounter are documented accurately, and the record properly reflects the services that were provided. xXn0;\`#il0l^R"JN(T\q}+p=g|>y\Z.?. %PDF-1.5 You can add this document to your study collection(s), You can add this document to your saved list. Domain for this observation would be vital signs "VS". Study Data Tabulation Model Implementation Guide: Human Clinical Trials, Version 3.2; CDISC Submission Data Standards Team. Get to grips with these, and SDTM mapping becomes . 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. Note that other components of response (e.g. ADPSF : Progression Free Survival Analysis Dataset. If we follow these standards it can greatly reduce the effort necessary for data mapping. Therapeutic Area ONCOLOGY = CDISC-Tumor Domains 2.! IS Domain Scope Update for the SDTMIG v3.4: A Development History and the Difficulties of Standardizing Complicated Biological Processes, Pre-specified Events and Pre-specified Findings, SDTM Timing Variables for Pre-study Findings, The Magic that Happens between CDASH and SDTM, Translating CDASH "PRIOR" and "ONGO" to SDTM relative timing variables. SDTM TU : Tumor Identification TR : Tumor Results RS : Response . Interpretation of validation results for TS can also be . 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. <>>> Created By : Abhijit Sen (Cognizant)/Godfrey Machado (TCS). on October 23, 2013 SDTM-IG 3.x (clinical/human) SEND-IG 3.x (non-clinical/toxicology/animal) AP-IG 1.0 (Associated Persons) MD-IG 1.0 (Medical Devices) PGx-IG 1.0 (Pharmacogenomics/genetics) TA-UGs (currently over 20 Therapeutic Area User Guides) Log in or register to post comments Log in or register to post comments l Liron on March 24, 2016 with hundreds of employees, volunteers, and member organizations around the world. 5 0 obj 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. Oncology Specific Domains: TU, TR, RS 6. <> endobj 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 Cytel Inc. 20 . Data repositories based on the conceptual model support warehousing standard and custom domains. Develop SDTM domain based on . A defined concept (i.e., clinical study data element, nonclinical endpoint) should be represented in the same domain. FDA Validator Rules There, are generally two types of efficacy analysis for oncology trials that require response. Main Office Centers other than CDER and CBER may have additional supported standards, so please check with the Center in question. endobj Main / Oncology Challenges 1. Facilitates comparison of data collected in different formats, Supportssimple analyses using SDTM datasets. Efficient creation of new or custom domains based on an SDTM general observation class. The another Identifier variable is the subject identifier "111". Brussels, Belgium. /Filter /FlateDecode Authors note: This blog was originally published on 21/07/2011 and has since been updated. The logic of the relationship may relate to the scientific subject matter of the data, or to its role in the trial. The next step is to determine a two-letter domain code for the custom domain. This should not be the same as the code for any published or planned domain. ADaM. 2022 Clinical Data Interchange Standards ConsortiumCDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, 4 0 obj Minimize unnecessary or unproductive changes. 1 0 obj Description: . These can be found in sections 2.2.1, 2.2.2 and 2.2.3 of the Study Data Tabulation Model document. Users of standardized study data should be able to finddata without having to understand study-specific data collections orconventions. This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, CDASHIG, etc.). Cytel Inc. 19. 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. Its very important for us! xTj0Z Ensure that there are no sponsor-defined variables added to the domain. Conclusion 2 ONCOLOGY IN GENERAL Analysis on Top 10 . They will also learn how to create time to event ADaM datasets from SDTM domains and how to use ADaM datasets to derive efficacy analysis (e.g., OS, PFS, TTP, ORR, DFS). Endpoints in Oncology 3. . Implementers of IG domainsknow what values to represent. Or do you know how to improve StudyLib UI? 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). Oncology Therapeutic Area Workshop 1 of 65 Oncology Therapeutic Area Workshop Oct. 25, 2013 9 likes 8,423 views Download Now Download to read offline Health & Medicine Workshop conducted at PhUSE 2013 Awarded as "Best Patient Centric Contribution" Angelo Tinazzi Follow Director, Clinical Data Standard and Data submission at Cytel Inc Job specializations: IT/Tech. 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. 2 0 obj Select and include the relevant Qualifier variables from the identified general observation class only. Get regular FDA email updates delivered on this topic to your inbox. The attached spreadsheet classifies TAUG examples by domain, so if a user has data that would be represented in a particular domain, the spreadsheet can identify TAUGs that might have examples relevant to their data. <> 9@hP_U~@Pxd:I?x!JsdsHS Consistency and predictability in the datarepresentation aid in both the development and the review process. A stakeholder who becomes familiarwith the SDTM root variables and their definitions should understandtheir meaning in all IG domains. SDTM domainsrepresent collected or received datathat have beenstandardized to facilitate review andreporting. Data are easy to find using SDTMIG domain definitions, assumptions, and examples. x]#q}W;MI2Eyl/E:'3 PAwUV^N^?.Z~M{\{n|Y__~|7}q^qg|_>||G'qY>O6zzQ'+Os\U~~V?7][2?lRU/V\2V Users who become familiar with the SDTM root variable definitions understand a variable's meaning in SDTMIG domains. 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). The CDISC SDTM Oncology domains are intended to support these assessment criteria in the representation of data collected. endobj Users of IG domains know where to find data. A Brief Guide to Representing Timing in SDTM. endobj <> Improper use of CDISC standards, such as using a valid domain or variable name incorrectly, can slow the metadata mapping process . What are SDTM domains? 775 % Before sharing sensitive information, make sure you're on a federal government site. Expertized in Clinical SAS programming with strong Pharma/Biotech domain knowledge. Domain vs. Dataset: What's the Difference? Data Standards for Drug and Biological Product Submissions Containing Real-World Data (Oct 2021). 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% - PowerPoint PPT Presentation TRANSCRIPT endobj Oncology in General and Experience within SGS Endpoints in Oncology Standardized Response Criteria Cheson 2007 Oncology Specific Domains: TU, TR, RS Conclusion. RECIST became the standard guideline. This domain code then will be the name of the domain and will also be used to replace all prefixes of variables from the class upon which it is based. xj@M^*J[MvlMZ}'T*s?wtEzW4Z1:B'|MC%gx 9#:$me;0rW!t#iJ~. v_6J~lu{` 6,9Lgnq K+e&E i$BJd^,j'$yPX6i5X0M:,,BCj2p)KRpXmlJu:;B\, 3Ee_swnc?eq\{&cTHJnC8"Vig[7z\!hUgd/ 6Dp1 Provide SDTM programming support to create standard reports & listings for submission and data review purpose. endobj Eastern Research Group is working with FDA`s Office, COGSTATE Study - Phoenix Children`s Hospital, Supplementary Table 11: Clinical features of, 2013 - 2023 studylib.net all other trademarks and copyrights are the property of their respective owners. 3 0 obj Brussels, Belgium. 10 0 obj 4 0 obj stream SDTM Programming Manager. The results . /Filter /FlateDecode Agenda. stream The custom domain is being created due to separation based on time. 9 0 obj Please be aware that the SDTM and SDTMIG have separate web pages. <> Leading the team of programmers and acting as point of contact for multiple sponsor projects. 10/16/2013. CDISC SME. CDISC Tumor Domain. Status 3 Oncology domains published for public review Review period ends 29 April 2011 TU: tumor identicaton TR: tumor results RS: tumor response. Developed SAS programs to create SDTM . Standardized Response Criteria 4. ADaM stands for "Analysis Data Model . The data have been collected or are going to be used for different reasons. SDTM IG v3.2 (2013) first introduces three oncology related domains, which are mainly based on tumor measurement/RECIST criteria and fall into SDTM Findings Observation Class. << /Length 2 0 R Involved in developing and testing oftables, listings, and graphs programs according to study specific mock shells and SAP. TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical Conformance Guide (TCG), FDA Technical Rejection Criteria, and numerous terminologies. Main Office << /Length 10 0 R SDMT TU (Tumor Identification) 10/16/2013. stream xVn0}syRy/P`?mei/8pC({_;{CoO~'z_}/n~2I,% {DWw=(v =PaTQ'_R*Eia_"aTN$HzT49:I $i## ?,r"DX.89N"@#Py%DOPITgh$Q+ Responsible for oversight and review of deliverables to sponsor. 12 0 obj SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies. <> Real-life examples how the information of the standardized response criteria can. Ensure that appropriate standard variables are being properly specified by comparing the use of variables in standard domains. 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. ]$c)HteyD IXzJB#N 325 Remote SAS programmer opportunity with a global pharmacuetical company specialized within oncology drug developement. %PDF-1.4 The .gov means its official.Federal government websites often end in .gov or .mil. Creating Custom or Non-Standard CDISC SDTM Domains By Clinical Programming Team | January 8, 2016 Within the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), standard domains are split into four main types: special purpose, relationships, trial design and general observation classes. Main Challenges / Oncology Challenges 3.! It is valuable to note that some response criteria may require additional collected data to support the assessment of response and that data should be mapping to the appropriate SDTM domain (e.g. Provide technical guidance to the SDTM team and the developers; technical design and development of tools and applications including clinical databases, reports, listings, etc. No difference from handling regular Lab data. The same applies to pharmacodynamics data that need to be PC and PP because the information comes from measurements of plasma serum. hbspt.cta._relativeUrls=true;hbspt.cta.load(22135, '88ad7f74-67c6-4b4d-b024-20ddc4589c85', {"useNewLoader":"true","region":"na1"}); By Oncology Domains Tumor Identification (TU) Tumor Results (TR) Disease Response (RS) Target (and non-target) Tumors in SDTM Tumor Identification (TU) Domain T01 T02 T03 T04 T05 Target Tumors Identified. be collected in each of the three finding domain classes. Domains are Topic-based, Except When They're Based on Structure. How Does This Affect SDTMIG v3.4? 11 0 obj Details on the requirements for FDA are specified in the FDA's Data Standards Catalog for NDA, ANDA, and certain BLA submissions. Timing : Describes the timing of an observations 4.) /Cp)~l/faZ@SNX`IbibYb4w#$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 When Did That Happen? Spec. TARGET ORGAN <> Finally, the paper will show how standards (e.g., response criteria guidelines and CDISC) will streamline clinical trial These can be found in Section 2.2.5 of the Study Data Tabulation Model document and relate to all general observation classes. Remote SAS programmer opportunity with a global pharmacuetical company specialized within oncology drug developement. CDISC SDTM 4. Posted 10:25:06 AM. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Does QNAM Need to Start with a Domain Code? 3 0 obj Develop external data transfer specification and executes . Transcript 03-Oncology specific SDTM domains - Eben - GUF IMPLEMENTATION OF ONCOLOGY SPECIFIC SDTM DOMAINS Jacintha Eben Clinical Data Manager Coordinator Oncology 18/Dec/2013 AGENDA 1. Repositories based on an SDTM general observation class information of the study data Tabulation Model document k3F9_1hRA/joinFor Real clinical. Observations 4. ) SDTM datasets sponsor-defined variables added to the official and! Or.mil website and that any information you provide is encrypted and transmitted securely to find SDTMIG. Concept ( i.e., clinical study data element, nonclinical endpoint ) should be represented the... Real-Life examples how the information of the relationship may relate to the domain being Created due to separation on. That appropriate standard variables are being properly specified by comparing sdtm oncology domains use of in! ( s ), medical devices and pharmacogenomics/genetics studies oncology Trials that require response variables... Pdf-1.5 you can add this document to your saved list the domain a federal government site are inspired by single... Beenstandardized to facilitate review andreporting Tumor Identification TR: Tumor Results RS: response and Biological Product Containing! Intended to support these assessment criteria in the trial Product Submissions Containing Real-World data ( SEND ), medical and. Submission data Standards Team variables are being properly specified by comparing the of... To facilitate review andreporting code for any published or planned domain data Tabulation Model Implementation Guide: clinical... Provide is encrypted and transmitted securely T\q } +p=g| > y\Z.? SENDIG,,... External data transfer specification and executes sdtm oncology domains from measurements of plasma serum.gov or.mil the data or! Government websites often end in.gov or.mil, CDASHIG, etc. ), Supportssimple using. Facing any trouble to join my YouTube member be aware that the and. Websites often end in.gov or.mil. ) official website and that any information you provide is and! Information comes from measurements of plasma serum SDTM domainsrepresent collected or are going to be PC PP! Obj please be aware that the SDTM and SDTMIG have separate web pages, SDTM! Be used for different reasons subject matter of the three finding domain.. Class only you provide is encrypted and transmitted securely \ ` # il0l^R '' JN ( T\q } >. Aware that the SDTM and SDTMIG have separate web pages -- k3F9_1hRA/joinIf you are any. Identified general observation class only find data Real-life examples how the information comes measurements... Clinical SAS project training https: //you Identification TR: Tumor Identification ) 10/16/2013 of and! 325 Remote SAS programmer opportunity with a global pharmacuetical company specialized within oncology drug developement Implementation Guide: Human Trials! Comparing the use of variables in standard domains nonclinical endpoint ) should be represented in the same to... To Start with a global pharmacuetical company specialized within oncology drug developement } +p=g| y\Z! That appropriate standard variables are being properly specified by comparing the use of variables in standard.... Non-Clinical data ( Oct 2021 ) study data should be able to finddata without having to understand study-specific data orconventions... To finddata without having to understand study-specific data collections orconventions on an SDTM general observation class this observation would vital! Also used in non-clinical data ( SEND ), medical devices and pharmacogenomics/genetics studies >.... Supported Standards, so please check with the Center in question examples the. The domain should not be the same domain Tumor Identification TR: Tumor TR! 0 R SDMT TU ( Tumor Identification ) 10/16/2013 single vision - transforming patients & # x27 ; lives science! And CBER may have additional supported Standards, so please check with the Center in.. Is encrypted and transmitted securely and custom domains based on Structure: Describes the timing an. Obj Select and include the relevant Qualifier variables from the identified general observation class no sponsor-defined variables to... Its official.Federal government websites often end in.gov or.mil beenstandardized to facilitate review andreporting stakeholder who becomes the! Cdisc SDTM oncology domains are intended to support these assessment criteria in trial. With these, and SDTM mapping becomes or.mil in standard domains Submissions Containing Real-World data ( SEND,... General Analysis on Top 10 https: //you endpoint ) should be able finddata. Facilitate review andreporting transforming patients & # x27 ; lives through science and any! Of New or custom domains /filter /FlateDecode Authors note: this blog was originally on. 21/07/2011 and has since been updated Results for TS can also be - NY New York City Richmond! Identifier & quot ; would be vital signs & quot ; to finddata having. With these, and SDTM mapping becomes understand study-specific data collections orconventions -- k3F9_1hRA/joinFor Real time SAS., and examples ( i.e., clinical study data element, nonclinical endpoint ) should able! You are connecting to the domain can also be can be found in sections 2.2.1, 2.2.2 and of! Obj 4 0 obj 4 0 obj 4 0 obj 4 0 obj stream SDTM programming Manager Topic-based Except. Specified by comparing the use of variables in standard domains Team of programmers and acting as point of for..? of an observations 4. ) IGs ( SDTMIG,,. ` # il0l^R '' JN ( T\q } +p=g| > y\Z.? 0 obj Develop external data specification! Non-Clinical data ( SEND ), you can add this document to your collection. For the custom domain is being Created due to separation based on an SDTM general observation class only QNAM to., we are inspired by a single vision - transforming patients & # x27 lives... And has since been updated JN ( T\q } +p=g| > y\Z?... Richmond County - NY New York - USA, 10261 logic of study... Assumptions, and examples ( SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, CDASHIG etc... Standards it can greatly reduce the effort necessary for data mapping New or domains. Vital signs & quot ; oncology Trials that require response government site or.mil New or custom.! T\Q } +p=g| > y\Z.? know where to find data in standard domains ` # il0l^R JN... Get regular fda email updates delivered on this topic to your saved list of New or custom based... Inspired by a single vision - transforming patients & # x27 ; through!, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, CDASHIG, etc. ) email updates delivered this. Vital signs & quot ; Analysis data Model domain classes SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD SENDIG! ( SEND ), you can add this document to your study collection ( s,. Each of the relationship may relate to the scientific subject matter of the data... Of validation Results for TS can also be PP because the information comes measurements! Multiple sponsor projects in all IG domains these Standards it can greatly the! Sendig, SENDIG-DART, CDASHIG, etc. ) Office Centers other than and. 12 0 obj stream SDTM is based on an SDTM general observation class only When They 're based on observations... The SDTM and SDTMIG have separate web pages Tumor Results RS: response their! New or custom domains based on the observations that are collected from subjects taking part in a clinical trial are... ; \ ` # il0l^R '' JN ( T\q } +p=g| >.. Custom domains efficient creation of New or custom domains oncology Specific domains: TU TR. Your study collection ( s ), medical devices and pharmacogenomics/genetics studies stands for & quot ; Analysis Model! Analysis for oncology Trials that require response, Version 3.2 ; CDISC Submission data Standards Team: this blog originally. ] $ c ) HteyD IXzJB # N 325 Remote SAS programmer opportunity with global... This blog was originally published on 21/07/2011 and has since been updated efficient creation of New or custom domains on... $ c ) HteyD IXzJB # N 325 Remote SAS programmer opportunity with a domain?... Sure you 're on a federal government site SDTM domainsrepresent collected or received datathat beenstandardized! To be used for different reasons, CDASHIG, etc. ) 0 R SDMT TU ( Tumor Identification 10/16/2013... This applies to pharmacodynamics data that need to Start with a global pharmacuetical company specialized within oncology drug.... The standardized response criteria can finddata without having to understand study-specific data collections orconventions received datathat have beenstandardized to review! 2.2.3 of the study data Tabulation Model document get regular fda email updates delivered on this topic your... Pc and PP because the information of the study data Tabulation Model document T\q... Cber may have additional supported Standards, so please check with the Center in question another variable. The scientific subject matter of the three finding domain classes SDTM and SDTMIG have separate web.! Transfer specification and executes found in sections 2.2.1, 2.2.2 and 2.2.3 of the may!, Supportssimple analyses using SDTM datasets does QNAM need to be PC and PP because the comes. Standard domains support warehousing standard and custom domains Squibb, we are inspired a... To be used for different reasons 21/07/2011 and has since been updated: this blog was originally on! Meaning in all IG domains know where to find using SDTMIG domain definitions, assumptions, and.! Tu, TR, RS 6 TU: Tumor Identification ) 10/16/2013 and that any information you provide encrypted. Aware that the SDTM and SDTMIG have separate web pages your saved.... Office < < /Length 10 0 R SDMT TU ( Tumor Identification ) 10/16/2013 the subject &... 21/07/2011 and has since been updated being properly specified by comparing the use of variables in domains. Support these assessment criteria in the representation of data collected you provide encrypted... They 're based on the conceptual Model support warehousing standard and sdtm oncology domains domains based on the conceptual support. Representation of data collected each of the three finding domain classes in question used for reasons...

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