Study Data Reviewer’s Guide

Study Data Reviewer’s Guide
FDA/PhUSE Project Summary

Agenda
• FDA/PhUSE Collaboration Overview
• Study Data Reviewer’s Guide (SDRG) Project
Summary

FDA/PhUSE Collaboration
FDA
Proclamation
We the Masses
Yearning for
Answers

Paradigm Shift
CRO
FDA
CDISC
Pharma
Vendor

Conferences/Meetings 2.0
• A different kind of event
• Collaborative working meeting
• Initially defined working groups focused on general
topics with projects
• Work does not stop when people go home – continue
the collaboration
• Work products, timelines, next steps

Working Group Structure
Working Group
Steering
Committee
Consists of 12
members from
industry/FDA
including:
liaison to WG
Industry/FDA PM
Project Reviewers
Data Quality
FDA Co-Leads
Industry Co-Lead
Steering Committee Liaison
Optimizing Data Standards
FDA Co-Leads
Industry Co-Lead
Steering Committee Liaison
Standard Scripts
FDA Co-Leads
Industry Co-Lead
Steering Committee Liaison
Non-Clinical Roadmap
FDA Co-Leads
Industry Co-Lead
Steering Committee Liaison
Emerging Technologies
FDA Co-Leads
Industry Co-Lead
Steering Committee Liaison
Project s
Project s
Project s
Project s
Project s

Study Data Reviewer’s
Guide (SDRG)
Purpose:
• Provide FDA Reviewers with additional context
and single point of orientation for SDTM datasets
submitted as part of eCTD Module 5
Project:
• Standards implementation identified by 2012
FDA/PhUSE WG4
• Work Package includes SDRG Template, SDRG
Completion Guidelines, SDRG Examples

SDRG Work Package (WP)
SDRG Template:
• Structured template designed to facilitate the
consistent development of a SDRG
SDRG Completion Guidelines:
• Set of instructions and partial examples designed
to aid sponsors developing a SDRG from the
template
SDRG Examples:
• Complete SDRG examples developed by SDRG
Team members using “real-world” SDTM data

SDRG Content
Introduction:
• SDRG overview and standards inventory
Protocol Description:
• Brief orientation to the study and additional
context about the Trial Design Datasets
Subject Data Descriptions:
• Additional context for subject-level datasets that
are not adequately documented by define.xml

SDRG Content (Cont.)
Data Conformance Summary:
• Inputs used to evaluate SDTM conformance and
summary of conformance findings
Appendix I: Inclusion/Exclusion Criteria:
• Full description of inclusion/exclusion criteria if criteria
cannot be documented in TI due to SAS v5 limitations
Appendix II: Conformance Issues Details
• Detailed record-level description of conformance
issues
• Sponsors are strongly discouraged from including this
section

SDRG Project Milestones
18-Mar-12: SDRG Kickoff at FDA/PhUSE CSS
01-Jun-Aug-12: Identification of SDRG content
21-Oct-12: SDRG Core Team F2F
15-Nov-12: 1 st draft of template and completion
guidelines posted to PhUSE Wiki
18-Dec-12: Prequalification completed
25-Feb-13: Final WP released for WG4 review
18-Mar-13: v1 provided to FDA CSC

SDRG Project Challenges
“Building the plane while flying”
• Narrowing broad working group focus to discrete projects
• Technical challenges with online collaboration tools
• Core Team day jobs
• Identifying and herding additional volunteers
“Purposeful Duplication”
• Balancing duplication in the SDRG with other project
documentation and single-point of orientation requirement
• Significant discussions occurred between FDA and industry
regarding duplication with the protocol, clinical study
report, define.xml, etc.

Next Steps
Next Steps:
• CSC to pilot SDRG with sponsors
• Sponsors are welcomed, but NOT REQUIRED
to use the SDRG Work Package to develop
SDRGs for their SDTM submissions
• Analysis Data Reviewer’s Guide kicked off at
2013 FDA/PhUSE CSS
– Additional volunteers are needed - join the team
today!

Purpose:
Analysis Data Reviewer’s
Guide (ADRG)
• Provide FDA Reviewers with additional context
and single point of orientation for ADaM
datasets submitted as part of eCTD Module 5
Project:
• Analysis Data Reviewer’s Guide (ADRG) project
launched at 2013 FDA/PhUSE CSS

ADRG Preview
Purpose:
• Provide FDA Reviewers with additional,
human-readable documentation of analysis
methods, datasets, and results that cannot be
fully explained by ADaM metadata
Project Leadership:
• Susan Kenny (Amgen), Gail Stoner (J&J), Mina
Holen (FDA)

ADRG Project Tasks
• Define ADRG Scope
• Develop draft ADRG template and completion
guidelines
• Vet draft documents
• Finalize draft ADRG template, completion
guidelines and ADRG examples
• Release ADRG Work Package for public comment
• Finalize ADRG Work Package and release for use

Acknowledgements
SDRG Core Team:
• Steve Wilson, FDA
• Helena Sviglin, FDA
• Douglas Warfield, FDA
• John Brega, Pharmastat
• Joanna Koft, Biogen-Idec
• Gail Stoner, Johnson & Johnson
• Scott Bahlavooni, Genentech
• David Brega, Pharmastat