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)
Prafulla Girase Define-XML v2.0 Completion Guidelines Co-Lead Biogen prafulla.girase (at)
Dmitry Kolosov Define-XML v2.0 Style Sheet Co-Lead PAREXEL International dmitry.kolosov (at)
Lex Jansen CDISC Define-XML Team Liaison (Define-XML v2.0 Style Sheet) SAS Institute Lex.Jansen(at)

Project Members

Define-XML 2.0 Implementation, "Completion Guidelines" document

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

Define-XML 2.0 Style Sheet Recommendations

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

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