Difference between revisions of "Data Reviewer's Guide in XML"

From PHUSE Wiki
Jump to: navigation, search
m (Project Overview)
m (Project Members)
Line 87: Line 87:
| Sergiy Sirichenko||Pinnacle 21||[mailto:ssirichenko@pinnacle21.net Sergiy(at) pinnacle21.net]
| Sergiy Sirichenko||Pinnacle 21||[mailto:ssirichenko@pinnacle21.net Sergiy(at) pinnacle21.net]
| Pranab Mitra||Merck||[mailto:pranab.mitra@merck.com pranab(at)merck.com]

Revision as of 06:12, 12 August 2019

Project Overview

This project will develop the Data Reviewer's Guide (i.e., cSDRG, nSDRG and ADRG) in an XML format for regulatory submissions. Furthermore, to identify and develop style sheets, elements and semantics capability. To also assess a more cohesive cross-documentation data exchange between the define.xml and data reviewer's guide as an XML format. Please note, the project intends to use the existing Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewers Guide (SDRG) as its basis.

NEW SUB TEAM SDSP-XML As conducted with the DRG-XML project (still ongoing), to develop a machine readable version of the Study Data Standardization Plan (SDSP) as XML. The deliverable for this project is to provide a prototype SDSP-XML package (i.e., sdsp.xml, sdsp.xsl, sdsp schema, and overview guide).

Project Deliverables

cSDRG Final Package Prototype (2018-07-27)
Disclaimer: This draft prototype package is not yet intended for public use and should not be referenced and/or otherwise used.

File:CSDRG XML Final Prototype Package 2018-08-10.zip

Package Summary:

  • csdrg concept map.pdf
    • Supporting concept map of the cSDRG provides a high-level perspective of the various optional/require responses, branching elements, and correlating rules in the construction of the document. Note: Recommend opening in Adobe Acrobat Viewer.
  • csdrg.xml
    • Prototype cSDRG in XML format, which is inclusive of content from the included PhUSE study-data-reviewers-guide-example-source.doc. Note: View in Internet Explorer.
  • csdrg-ns.html
    • Prototype cSDRG in HTML format.
  • define.xml
    • Example CDISC Define-XML v2.0 document to illustrate the linking mechanism in-between the csdrf.xml and define.xml. User Note: A corresponding link from define.xml to csdrg.xml does not exist.
  • define2-0-0.xsl
    • Stylesheet used to visually present the define.xml content.
  • Protocol_Design_SDRG_001A.jpg
    • Protocol design graphic extracted from the PhUSE study-data-reviewers-guide-example-source.doc to present within the csdrg.xml.
  • sdrg1-0-0.xsl
    • Stylesheet used to visually present the csdrg.xml content.
  • study-data-reviewers-guide-example-source.doc
    • Example cSDRG obtained from the PhUSE CSS cSDRG package v1.21.
  • Schema (folder)
    • This folder contains the schema and associated references within sub-folders sdrg-1.0, cdisc-odm-1.3.1, cdisc-odm-1.3.2, and cdisc-sdm-1.0.0.
  • sdrg-ns.html
    • Technical specifications of the csdrg.xml. Note: View in Internet Explorer.

Project Leadership Team

Name Role Organization E-mail
Mike Hamidi Project Leader CDISC mhamidi@cdisc.org

Project Members

Name Organization E-mail
Brad Moran Pinnacle 21 Bmoran (at) pinnacle21.net
Crystal Allard FDA Crystal (at) fda.hhs.gov
Gerry Campion Accenture Gerry(at) accenture.com
Jozef Aerts XML4Pharma info(at) xml4pharma.com
Max Kanevsky Pinnacle 21 Max(at) pinnacle21.net
Max Williams Eli Lilly Max(at) lilly.com
Pritesh Solanki Merck Pritesh(at) merck.com
Sergiy Sirichenko Pinnacle 21 Sergiy(at) pinnacle21.net
Pranab Mitra Merck pranab(at)merck.com

Project Updates

  • Team kick-off initiated on Jan. 12th, 2017
  • Evaluating existing cSDRG components for Proof-of-Concept
    • Refer to project timelines below regarding estimated timing
  • CSS 2017 Presentation Slide Deck
  • Team completed the final prototype package on July 27, 2018
  • Targeting a Q3/Q4 2018 public review period.

Objectives and Timelines

Please find the supporting project information and timelines.

Meeting Minutes

Please find all available meeting minutes below.