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
CommitteeConsists of 12 members from industry/FDA
including:liaison to WG
Industry/FDA PMProject Reviewers
Data QualityFDA Co-Leads
Industry Co-LeadSteering Committee Liaison
Optimizing Data StandardsFDA Co-Leads
Industry Co-LeadSteering Committee Liaison
Standard ScriptsFDA Co-Leads
Industry Co-LeadSteering Committee Liaison
Non-Clinical RoadmapFDA Co-Leads
Industry Co-LeadSteering Committee Liaison
Emerging TechnologiesFDA Co-Leads
Industry Co-LeadSteering 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 SDRGSDRG 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 findingsAppendix I: Inclusion/Exclusion Criteria:• Full description of inclusion/exclusion criteria if criteria
cannot be documented in TI due to SAS v5 limitationsAppendix 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: 1st 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 REQUIREDto 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!
Analysis Data Reviewer’s Guide (ADRG)
Purpose:
• Provide FDA Reviewers with additional context and single point of orientation for ADaMdatasets 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