# Presentation: 714146

## Steve Wilson, CAPT, USPHS
Deputy Director, Division of Biometrics II/CDER/FDA

SESSION 366 DM - DOCUMENT MANAGEMENT, CDM, IT 
Electronic Submission Data Standards – Part 1 of 2: Agency Update 
SESSION CHAIRPERSON Wayne R. Kubick, MBA 
Vice President, Lincoln Technologies, Inc. 
40th Annual DIA Meeting
1: 30 PM - 3: 00 PM Room 146A, Wednesday, June 16, 2003 
Washington, DC, USA

*Deputy Director, Division of Biometrics II/CDER/FDA*
- SESSION 366 DM - DOCUMENT MANAGEMENT, CDM, IT
*Electronic Submission Data Standards – Part 1 of 2: Agency Update *
- SESSION CHAIRPERSON Wayne R. Kubick, MBA
*Vice President, Lincoln Technologies, Inc.*
**40th Annual DIA Meeting**
**1: 30 PM - 3: 00 PM Room 146A, Wednesday, June 16, 2003 **
**Washington, DC, USA**

- Standard Data & eReview Tools

## Disclaimer

- Views expressed in this presentation are those of the speaker and not, necessarily, of the Food and Drug Administration

## Acknowledgements

- Randy Levin
- Wayne Kubick
- Rebecca Kush
- Ed Nevius
- Al Presseller
- Chan Russell
- Norman Stockbridge

## Outline

- Review, 21 CFR 11 & Electronic Submission
- CDISC & Study Data Tabulation Datasets (SDTDs)
- eReview Tools
- Patient Profiles
- WebSDM
- Looking Ahead

## Review – “Show me the DATA”

- Assess quality / completeness of data
- Verify results reported in the NDA
- Examine individual patient experience during clinical trial
- Ask and answer new review-related questions
- Communicate with the company

## Regulation: 21 CFR 11 

- Regulation that gave the FDA the ability to receive and archive e-submissions
- Needed to be ready to review before accepting submissions
- Electronic Document Room (EDR)
- Guidance describing submission (on the Docket)
- Desktop hardware/software
- Training
- Policies (e.g., MAPPs – SOPs)

## Electronic Submission of Data (Today)

- Study
- observation

- Processing System

- Patient profiles

- Data listings

- Tabulations

- Analysis

- Investigator

- Company

- FDA
- EDR

- Database

- Submission

## Electronic Document Room

## Datasets

## ?

## Download to Desktop Tools

- ?

## Standard Data + eReview ToolsHigher Quality + Efficiency

- Establish Good Review Practice (GRPs) standards
- Train reviewers
- Faster review
- Smarter review
- Review/decide consistently
- Use more of what we know (JANUS)
- Communicate with sponsors and each other
- ....
- ....

## Study Data Tabulation Datasets (SDTDs)

- Contain data collected/observed during the study and organized by clinical domain
- These datasets are described by CDISC as the SDT Model (SDTM) Version 3.1 standard
- The SDTM V3.1 model + Implementation Guide (developed by the CDISC/SDS Team) are now available from CDISC
- With SDTD and eReview Tools -- data listings and patient profiles can be generated by reviewers
- Recognition: Highly normalized (Long and skinny)
- NEED for STANDARD eREVIEW TOOLS even greater, more crucial!

- Adapted from Dave Christiansen, 2004

## eReview Tools

- Patient Profile Viewer
- WebSDM

## Patient Profile Viewer (PPV)

## Developing the PPV

- Design (Ana Szarfman & Crossgraphs)
- Cooperative Research and Development Agreement (CRADA) with PPD Informatics
- Pilot Project (Federal Register) with nine sponsors (SDS Version 2 and Version 3 data transformations/submissions)
- Success! Tool + Standard Data = Patient Profiles

## eReview Tool: PPV

## Web Submission Data Manager (WebSDM)

- Another CRADA partner:
- Functionality (Chan Russell):
- Enhance speed and quality of review of clinical trials data
- Validate data sets for conformance with the CDISC SDS/SDTM standards
- Transform SDS data into more usable views (by visit, by patient, by test)
- Browse, query and report on submission data
- Exchange subject list queries and report definitions
- Respond rapidly to queries

## Login

## Web Submission Data Manager

## Search Applications

- Select

## Select Application

## Select Study

## Domains Tab: Submitted Data

## Display Observations

## Set User Preferences

## Redisplay Data

## Data on an Individual Subject

## Details

## Review Definitions/Source

## Create Report

## Select Domain and Timing Variable

## Select Topic, Qualifier, Demographic Variables & Report “Type”

## Review Selections

## Graph From a Report

## Make Slections/Display Graph

## Copy From WebSDM

## Paste Into Review

## Select Patient of Interest

## Select View

## Integrated with PPV!

## Display and Choose Saved Reports

## Examine Selected Report

## Continuous Progress: Recent Upgrades to WebSDM

- Support for 3.1
- Support for define.xml (metadata for customer-added domains)
- Combination of the old "Browse" screen and the top-level screen (user request)
- Improved query and reporting
- Full Help system (per-page context help, table of contents to get to overview material)

## Standard Data + eReview ToolsHigher Quality + Efficiency

- Establish Good Review Practice (GRPs) standards
- Train reviewers
- Faster review
- Smarter review
- Review/decide consistently
- Use more of what we know (JANUS)
- Communicate with sponsors and each other
- ....
- ....

## Shameless Plug: Continuing the Conversation

**SESSION 420 ST - STATISTICS **
**Thursday,** June 17, 8: 30 AM - 10: 00 AM Room 140B
**Developing Best Practices and Regulatory Guidance for Statistical Analysis Plans and Databases **
**SESSION CHAIRPERSONS:** Mary Nilsson, (Lilly Research Laboratories) and Steve Wilson (FDA)
- This session will provide an overview of the challenges involved in developing best practices for the design, development, and documentation of statistical analysis plans, analyses as conducted, and databases. The speakers will describe and discuss current approaches employed by pharmaceutical companies and CROs to plan and document analyses, and issues associated with statistical review and the development of guidance.
- Mary Nilsson, Lilly Research Laboratories
- Russell Helms, Rho, Inc.
- Steve Wilson, FDA

## CDISC*-it!

- *SDS Version 3.1, of course

## THANK YOU

- _[wilsons@cder.fda.gov](mailto:wilsons@cder.fda.gov)_
- 301-827-5583
- For the next chapter....
- See You in Washington in 2005!