Data Reviewer's Guide in XML

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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.


Project Deliverables

  • cSDRG Proof-of-Concept Package - Q1/Q2 2018
    • Package Release Notes
    • cSDRG XML schema
    • cSDRG XML prototype*
    • cSDRG stylesheet
    • cSDRG concept map


*Supporting graphics; an existing PhUSE SDRG package example will be used

Project Leadership Team

Name Role Organization E-mail
Mike Hamidi Project Leader PRA Health Sciences hamidimike (at) prahs.com



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
Zuzana Rehm GSK Zuzana(at) gsk.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 targeting a Q1 2018 public review period.



Objectives and Timelines

Please find the supporting project information and timelines.




Meeting Minutes

Please find all available meeting minutes below.