German CDISC User Group - define.xml Workstream Reference List
Reference List - define.xml
Table of contents
1 Scope 2
2 CDISC Resources 3
2.1 CDISC Standards and Implementation Samples 3
2.2 CDISC Public Discussion Forums 3
3 Regulatory References (FDA) 4
4 Papers on define.xml Generation Processes 5
4.1 General 5
4.2 Process Papers and Discussion 5
5 Tools 8
5.1 Generation Tools 8
5.2 Validation Tools 8
5.2.1 Schema Validation 8
6 Presentations 9
7 Modification History 10
1 Scope
This document contains a collection of publications, papers and presentations referencing define.xml and the process of preparing deliverables for e-submissions.
This reference list is not exhaustive. The team member of the German CDISC User Group define.xml Workstream will make additions to this reference list, as applicable.
No assessments or recommendations are made.
2 CDISC Resources
2.1 CDISC Standards and Implementation Samples
· Case Report Tabulation Data Definition Specification (define.xml), V1.0
http://www.cdisc.org/models/def/v1.0/index.html
Contents:
Specification document, implementation sample incl. stylesheet, standard schemas.
· Draft Metadata Submission Guidelines, Appendix to the SDTM IG 3.1.1
http://www.cdisc.org/models/sdtm/v1.1/index.html
Contents:
Guidance document, implementation sample incl. enhanced stylesheet.
· CDISC SDTM/ADaM Pilot Project – Project Report
http://rs6.net/tn.jsp?t=4m4juicab.0.0.btzkurbab.0&ts=S0313&p=http%3A%2F%2Fwww.cdisc.org%2Fpublications%2FSDTMADaMPilotProjectReport.pdf
Note:
The submission package itself as well as a set of tools are available for CDISC Members in the members-only area of the CDISC website.
2.2 CDISC Public Discussion Forums
· CDISC Public Discussion Forum – Case Report Tabulation (CRT-DDS or define.xml)
http://www.cdisc.org/bbs/forums/forum-view.asp?fid=111
· CDISC Public Discussion Forum – SDTM/ADaM Pilot Project Report & Submission PKG
http://www.cdisc.org/bbs/forums/forum-view.asp?fid=123
· CDISC Public Discussion Forum - SDTM: Frequently Received Answers to Questions
http://www.cdisc.org/bbs/forums/forum-view.asp?fid=119
Note:
This forum is hosted by CDISC with content provided by the PhRMA Study Data Tabulation Model Best Review Practices Group. DISCLAIMER: Information posted on this website is volunteered by those submitting data via the SDTM standard to the FDA. The information provided on this site is for informational purposes only. It does not represent FDA policy or CDISC endorsement. Each sponsor is encouraged to have appropriate communications with the FDA.
3 Regulatory References (FDA)
· Electronic Common Technical Document (eCTD)
http://www.fda.gov/cder/regulatory/ersr/ectd.htm
Contents:
eCTD Guidance, related specifications, links to recent presentations by the FDA.
o Study Data Specifications, V1.4
http://www.fda.gov/cder/regulatory/ersr/Studydata.pdf
· CDISC Data Standards Resources
http://www.fda.gov/oc/datacouncil/cdisc.html
· SDTM Validation Specification, v1.0, November 2007 (draft)
http://www.fda.gov/oc/datacouncil/janus_sdtm_validation_specification_v1.pdf
4 Papers on define.xml Generation Processes
4.1 General
· Various CDISC related SAS papers from SAS Global Forum, SUGI, PharmaSUG, NESUG, SESUG, PhUSE, WUSS, MWSUG, PNWSUG and SCSUG
http://www.lexjansen.com/cdisc/
=> TODO: reference papers referring to define.xml
4.2 Process Papers and Discussion
N.B. f the Ref. No is shaded green, the paper has been discussed in the Define.xml work stream of the German CDISC User Group
Ref. No / Title and Link / Discussions /1 / Supporting CDISC Standards in Base SAS® Using the SAS® Clinical Standards Toolkit
Peter Villiers / − Describes the SAS Clinical Standards Toolkit which can be used for define.xml generation
− Revisit this paper when the SAS Clinical Standards Toolkit is available (probably May 2009) and workstream members had the chance to test it
2 / A SAS® Programmer’s Guide to Generating Define.xml
Michael Molter / − Background information on define.xml and XML in general, good introduction for define.xml beginners
− Solution to create define.xml in SAS via ODS Markup
− Workstream members currently not overly familiar with SAS ODS Markup
3 / Using SAS® Clinical Data Integration Server to Implement and Manage CDISC Standards
Michael Kilhullen / − Presentation of SAS Clinical Data Integration Server
− Metadata management
− Interface to SAS Clinical Standards Toolkit enables generation of define.xml
− More insight is needed for a real evaluation
− The workstream members from Baxter may share their experience with the SAS Clinical Data Integration Server in autumn
4 / Using the SAS® XML Mapper and ODS to create a PDF representation of the define.xml
Lex Jansen
Octagon Research Solutions / − Good background information on define.xml
− Solution to convert define.xml to define.pdf in order to have a printable version if the FDA ask for it
− The link to the respective presentation will be provided in the presentations section of this document
− SAS XML Mapper has not yet been used by the workstream members
− Members may share their experience with using this application later this year
5 / Cost-Effective Solution to Automating the Creation of CDISC define.xml: Using SAS Data _Null_ with Relational Data Model via SAS/AF Application
Annie Guo
ICON Clinical Research / − SAS AF application for input and management of metadata
− Automatic creation of define.xml via SAS DATA _NULL_ PUT statements
− Relational data model
− Process is described as “reverse-engineering” making use of the SDTM metadata already inherent in the SAS datasets and adding the additional information needed via “data entry” in SAS/AF application windows
− Process can be adapted for “forward engineering”, i.e. creation of SAS programs that create the study database in SAS
6 / A SAS based solution for define.xml
Monika Kawohl
Accovion / − Specifications files including all metadata required for define.xml (Format: Excel)
− Merge and comparison of SAS inherent metadata (SAS dictionary tables) with additional metadata from specification files
− Automatic creation of define.xml via SAS DATA _NULL_ PUT statements
− Final manual QC step to verify correct CRF Page links
− The powerpoint presentation will provided at the presentations section of German CDISC User Group – workstream define.xml/e-submissions portal
7 / From CRF Data to DEFINE.XML: Going “End to End” with Metadata
Frank C DiIorio
CodeCrafters, Inc.;
Jeffrey M Abolafia
Rho, Inc. / − Describes a well designed process.
− Includes many informative flow charts which help to understand the process more clearly.
− Gives a good technical overview supported with SAS scripts
− Part 1 of a series of 3 papers
(see # 9 and 10 below)
8 / CDISC Implementation Step by Step: A Real World Example
Sy J Truong
Meta-Xceed, Inc.;
Patricia Gerend
Genentech, Inc. / − A lot of general information which in the beginning of the paper runs a little bit off the topic.
− Definedoc used for generating define.xml.
− MS Excel Spreadsheets can be exported and re-imported with Definedoc.
9 / The Design and Use of Metadata: Part Fine Art, Part Black Art
Frank C DiIorio
CodeCrafters, Inc.;
Jeffrey M Abolafia
Rho, Inc. / − Proceedings of the Thirty-first Annual SAS® Users Group International Conference, 2006.
− Part 2 of a series of 3 papers
(see # 7 and 10)
10 / Managing The Change And Growth Of A Metadata-Based System
Frank C DiIorio
CodeCrafters, Inc.;
Jeffrey M Abolafia
Rho, Inc. / − Paper RS09
−
− Part 3 of a series of 3 papers
(see # 7 and 9)
5 Tools
5.1 Generation Tools
· SDTM-ETLTM (XML4Pharma)
http://www.xml4pharma.com/SDTM-ETL/index.html
· DefinedocTM (MetaXceed)
http://www.meta-x.com/definedoc/index.html
· OriginTM Submission Modeller (Formedix Ltd.)
http://www.formedix.com/
· S-CubedR – CRT (datafarm)
http://www.datafarminc.com/Products-DefinePDF.aspx
· Define.xml generator/entimICE® (entimo®)
http://www.entimo.com/solution/entimICE_Define_xml.html
· SAS Clinical Standards Toolkit
http://support.sas.com/rnd/base/xmlengine/proccdisc/index.html
5.2 Validation Tools
· define.xml checkerTM (XML4Pharma)
http://www.xml4pharma.com/CDISC_Define_Checker/index.html
· WebSDMTM (Phase Forward)
http://www.phaseforward.com/products/clinical/ads/default.aspx
5.2.1 Schema Validation
· Exchanger XML Editor (Cladonia)
http://www.exchangerxml.com/
· oXygen XML Editor
http://www.oxygenxml.com/
· DecisionSoft XML Schema Validator
http://tools.decisionsoft.com/schemaValidate/
6 Presentations
· Define.XML: Implementation experiences and user expectations
http://www.cdisc.org/publications/euinterchange2008/day1/session7/MonikaKawholS7Tk1.pdf
· “The Wonderful World of Define.xml … Practical Uses Today”, Mark Wheeldon, DC User Group Washington
http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/North%20America/Washington%20DC/Presentations/Define.xml_Presentation_9Dec08_Revised.pdf
· Using the SAS® XML Mapper and ODS to create a PDF representation of the define.xml
Lex Jansen, Octagon Research Solutions
http://www.lexjansen.com/papers/PhUSE2008-CD04_ppt.pdf
· A SAS based solution for define.xml
Monika Kawohl, Accovion
http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/Define.xml/Presentations/PhUSE_SDE_define.ppt
· The SAS® Clinical Standards Toolkit: An Initial Review
Chris Decker, Tim Thompson, d-Wise
http://www.d-wise.com/company/news/97-d-wise-to-present-webinar-on-the-sas-clinical-toolkit
(You will need to create an account and log on to access the information)
=> TODO: reference more presentations on define.xml
7 Modification History
Date / Summary of relevant changes / Modified by /02-Mar-2009 / Initial set-up of reference list / Monika Kawohl
06-Mar-2009 / Structural changes as agreed at the workstream TC on 03-Mar-2009 / Monika Kawohl
25-Mar-2009 / New schema validation tool (5.2.1) and new presentation (6) added / Monika Kawohl
21-Apr-2009 / Discussion of define.xml generation process papers (4.2) added / Pia Ebhart, Monika Kawohl
28-Apr-2009 / New process paper (4.2 #7,8) added
New presentation links (6) added / Pia Ebhart, Monika Kawohl
21-Sep-2009 / Updated Sections:
5.1 Generation Tools
6 Presentations / Monika Kawohl
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