Out-of-the-box %definexml
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1 Out-of-the-box %definexml Just a Simple SAS Macro PhUSE / October 2016 / Katja Glaß
2 Agenda Introduction Getting Started %DefineXML Collaborate Summary Page 2 DefineXML Katja Glaß 11. October 2016
3 Introduction Define-XML transmits metadata for SDTM, SEND and ADaM datasets; datasets, variables, controlled terms, and other specified metadata... CDISC Define-XML definition Page 3 DefineXML Katja Glaß 11. October 2016
4 Introduction Define.xml Web View Page 4 DefineXML Katja Glaß 11. October 2016
5 Introduction Define.xml Text View Page 5 DefineXML Katja Glaß 11. October 2016
6 Getting Started Requirement: create a submission ready define.xml file How: various tools various possible processes Final Goal: complete transparency, automation, regular updates Solution: Do it yourself! Create a SAS macro! Page 6 DefineXML Katja Glaß 11. October 2016
7 Getting Started Internet Search Define-XML-2-0_ ReleasePackage ARM-for-Define-XML Define Papers Creating Define.xml v2 Using SAS for FDA Submissions Page 7 DefineXML Katja Glaß 11. October 2016
8 Getting started Inputs SDTM additional manual input SDTM data SDTM metadata define.xml ecrf / acrf additional mapping specifications Codelists & Thesauri RAVE loader information Page 8 DefineXML Katja Glaß 11. October 2016
9 Getting started Inputs ADAM ADAM data ADAM metadata define.xml additional manual input SAP, Protocol, TLF spec. additional mapping specifications Codelists & Thesauri Page 9 DefineXML Katja Glaß 11. October 2016
10 Getting started Inputs ADAM ADAM data ADAM metadata define.xml additional manual input SAP, Protocol, TLF spec. additional mapping specifications Codelists & Thesauri Page 10 DefineXML Katja Glaß 11. October 2016
11 Getting started Simplified process define.xml information define.xml Step 1 Step 2 Page 11 DefineXML Katja Glaß 11. October 2016
12 Getting Started Macro Development Update prototyp Prototyp Discuss with Experts (ADAM, SDTM, CDISC) Develop process(es) Page 12 DefineXML Katja Glaß 11. October 2016
13 Getting Started Short Term Process define.xml information define.xml %DefineXML Page 13 DefineXML Katja Glaß 11. October 2016
14 Getting started Long Term Process %CreateDefine define.xml information define.xml %CheckStructure %CheckContent %UpdateDefine %DefineXML %ManualUpdate %ReportChanges %ReportCheck Changes Page 14 DefineXML Katja Glaß 11. October 2016
15 %DefineXML Scope: Translation of information into XML format according CDISC specifications As interface SAS datasets are used Similar as Pinnacle21 tool, but using SAS and adding functionality define.xml information define.xml %DefineXML Page 15 DefineXML Katja Glaß 11. October 2016
16 %DefineXML Interface through datasets (similar as Pinnacle21): General Datasets Variables Value Level (including WhereClause) Codes & Terms Methods Comments Documents Page 16 DefineXML Katja Glaß 11. October 2016
17 %DefineXML Available through PhUSE Script Repository v Macros v Example v Documentation phuse-scripts / lang / SAS / datahandle / definexml Page 17 DefineXML Katja Glaß 11. October 2016
18 %DefineXML definexml_v1.sas Page 18 DefineXML Katja Glaß 11. October 2016
19 %DefineXML definexml_v1_attributes_for.sas Page 19 DefineXML Katja Glaß 11. October 2016
20 %DefineXML example_adam.sas Page 20 DefineXML Katja Glaß 11. October 2016
21 %DefineXML example_adam.xlsx Page 21 DefineXML Katja Glaß 11. October 2016
22 %DefineXML example_adam.xml define2-0-0.xsl Page 22 DefineXML Katja Glaß 11. October 2016
23 %DefineXML DefineXML - Macro Notes.docx Page 23 DefineXML Katja Glaß 11. October 2016
24 %DefineXML Macro is Open Source (MIT-License) Validation: Validate Define.XML result! Just use it! Page 24 DefineXML Katja Glaß 11. October 2016
25 Collaboration Room for improvements: Define Programming: Interface as Pinnacle21 Excel structure (%definexml_v2) Analysis Results Level metadata support Examples SDTM Examples ADAM / Update example Define-related Programming %ReadDefineXML %CreateInitialDefineData (proc contents, ) Page 25 DefineXML Katja Glaß 11. October 2016
26 Collaboration Room for improvements: Documentation: Programming Specification Guidance or How-to Document FAQ Page 26 DefineXML Katja Glaß 11. October 2016
27 Summary No more manual define.xml updates! Define.xml creation with correct structure can easily be done by the macro! Ready for use! Full Transparency! Easy to change! Out of the box! Page 27 DefineXML Katja Glaß 11. October 2016
28 Questions? Page 28 DefineXML Katja Glaß 11. October 2016
29 Thank you! PhUSE / 11. October 2016 / Katja Glaß
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