Define-XML V2.0 Completion Guidelines & Style Sheet Recommendations

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Project Overview

This project will be a group/round-table discussion on the need for a new project around documenting best practices in moving company implementation to Define-XML v2.0, or updating the existing style sheet. Starting with one CDISC Define-XML liaison, this group will discuss the needs and hone scope for more active discussions following the CSS 2016.

Define-XML 2.0 Implementation, "Completion Guidelines" document


Define-XML 2.0 Style Sheet Recommendations

  • The following 2 phases of the project have been defined:
    • Phase 1
      • Development of a Define-XML v2 stylesheet for regulatory submissions, by reviewing and updating the existing CDISC stylesheet.
    • Phase 2
      • Demonstrate other uses of a stylesheet, without bothering too much about current technical restrictions.
      • We can look at javascript libraries and frameworks to make the display more interactive.


Project Deliverables

Project Leadership Team

Name Role Organization E-mail
Marcelina Hungria CDISC Define-XML Team Liaison (Define-XML v2.0 Completion Guidelines) DIcore Group mhungria(at) DIcoreGroup.com
Prafulla Girase Define-XML v2.0 Completion Guidelines Co-Lead Biogen prafulla.girase (at) biogen.com
Dmitry Kolosov Define-XML v2.0 Style Sheet Co-Lead PAREXEL International dmitry.kolosov (at) parexel.com
Lex Jansen CDISC Define-XML Team Liaison (Define-XML v2.0 Style Sheet) SAS Institute Lex.Jansen(at) sas.com

Project Members

Define-XML 2.0 Implementation, "Completion Guidelines" document

Name Organization E-mail
David Brega PharmaStat dbrega (at) pharmastat.com
Deb Goodfellow Chiltern deborah.goodfellow(at)chiltern.com
Dmitry Kolosov PAREXEL dmitry.m.kolosov (at) gmail.com
Eric Crockett Chiltern eric.crockett(at)chiltern.com
Eric Du Gilead eric.du(at)gilead.com
Hongli Wang BMS hongli.wang2 (at) bms.com
Huanyu Chen (Jade) FDA huanyu.chen (at) fda.hhs.gov
Marcelina Hungria DIcore Group mhungria (at) dicoregroup.com
Peng Yang Clindata Insight pyang (at) clindatainsight.com
Steve Wong Cytel steve.wong (at) cytel.com
Kate Dwyer FDA kate.dwyer (at) fda.hhs.gov
Lili Garrard FDA lili.garrard (at) fda.hhs.gov
Lillian Qiu FDA aijun.qiu (at) fda.hhs.gov
Wei Dong Cytokinetics wwdong (at) yahoo.com
Yi-Ting Lin Gilead yi-ting.lin (at) gilead.com
Kiran Bonda Inventiv Health kiran.bonda (at) inventivhealth.com
Veerle Coenen Janssen vcoenen (at) its.jnj.com
John Brega PharmaStat jbrega (at) pharmastat.com
Sergiy Sirichenko Pinnacle21 ssirichenko (at) pinnacle21.net
Ishan Shah PRA Health Sciences shahishan (at) prahs.com
Sandra Vanpeltnguyen Pfizer sandra.vanpeltnguyen (at) pfizer.com
Hanming Tu Accenture hanming.h.tu (at) accenture.com
Hui Song PRA Health Sciences songhui (at) gmail.com
Jack Shostak DCRI jack.shostak (at) duke.edu
Jack Zhang FDA jack.zhang(at)fda.hhs.gov
Jamal Horne IBM jhorne(at)us.ibm.com
Jeff Florian FDA jeffry.florian(at)fda.hhs.gov
Jennifer Feldmann Instem jennifer.feldman (at) instem.com
Karen Curran CSG-Inc kcurran(at)csg-inc.com
Kajal Tahiliani Industry kajal.tahiliani (at) gmail.com
Lex Jansen SAS Institute lex.jansen (at) sas.com
Linda Collins Pharmastat lcollins (at) pharmastat.com
Majdoub Haloul Merck majdoub.haloul (at) merck.com
Patel Unnat Pfizer unnat.patel (at) pfizer.com
Patrick Stump GSK patrick.j.stump(at)gsk.com
Prafulla Girase Biogen prafulla.girase (at) biogen.com
Sally Cassells Industry sally.cassells (at) gmail.com
Sam Hume CDISC sam.hume (at) cdisc.com
Satheesh Avvaru PPDIsatheesh.avvaru (at) ppdi.com
Sherry Chou PAREXEL sherry.chou (at) parexel.com
Siwei Cheng PPDI siwei.cheng(at)pedi.com
Terek Peterson Chiltern terek.peterson(at)chiltern.com
Tina Nagrani Industry tnagrani1974 (at) gmail.com
Vicky Poulsen Novonordisk vicp (at) novonordisk.com
Vishnu Kollisetti PPDI vishnu.kollisetti(at)ppdi.com
Wendy Dobson PhUSE wendy (at) phuse.eu
Wei Dong Gene dong.wei(at)gene.com
Yan Lei JNJ YLei5 (at) its.jnj.com
Zhihai Zhang Gene zhihai.zhang(at)gilled.com

Define-XML 2.0 Style Sheet Recommendations

Name Organization E-mail
Dmitry Kolosov (Co-Lead) PAREXEL International dmitry.m.kolosov (at) gmail.com
Lex Jansen (CDISC Define-XML Team Liaison) SAS Institute lex.jansen (at) sas.com
Marcelina Hungria DIcore Group mhungria (at) dicoregroup.com
Herve Guimard Sanofi herve.guimard (at) sanofi.com
Rob Wartenhorst GSK rob.x.wartenhorst (at) gsk.com
Nicola Tambascia PRA Health Sciences Nicola.Tambascia (at) phuse.eu
Kiran Padhiar Lilly padhiar_kirankumar (at) lilly.com
Zuzana Rehm GSK zuzana.x.rehm (at) gsk.com
Sam Hume CDISC shume (at) cdisc.org
Jack Shostak DCRI jack.shostak (at) duke.edu
Patel Unnat Pfizer unnat.patel (at) pfizer.com
David Brega Pharmastat dbrega (at) pharmastat.com
Hongli Wang BMS hongli.wang2 (at) bms.com
Hui Song PRA Health Sciences songhui (at) gmail.com
Kiran Bonda inVentiv Health kiran.bonda (at) inventivhealth.com
Yi-Ting Lin Gilead yi-ting.lin (at) gilead.com
Majdoub Haloui Merck majdoub.haloul (at) merck.com
Wendy Dobson PhUSE wendy (at) phuse.eu

Project Updates

This is a new project and updates will be made once the project team and lead are identified.

Objectives and Timelines

Objective Timeline
xxxxx xxxxx


Project Content and Activities

  • At the PhUSE CSS sessions on 13 March and 14 March 2016 the following was discussed:

CSS 2016 Working Group Sessions Minutes


Meeting Minutes

Define-XML 2.0 Implementation, "Completion Guidelines" document

Define-XML 2.0 Style Sheet Recommendations