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

FDA

Pharma

CRO

CDISC

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

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

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