Informatics Core

Informatics Core

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ADCS Steering Committee Meeting - Spring 2015

On Github gajimenezmaggiora / informatics-201504

Informatics Core

Gustavo Jimenez-Maggiora, MBA

Washington, DC

April 19th, 2015


New Data Portals

Portal Status FYN Launched!!! ADNID Launched!!! CCF-RAS Launched!!! LEARN May, 2015 TCAD Extension May, 2015 EX In progress... CSF 1 In progress...

Amazon Web Services (AWS)

  • We have migrated the majority of our Data Portals to AWS
  • Remaining Data Portals:
    • A4
    • TCAD

Application Improvements

  • Based on user feedback, we have made improvements to the following apps:
    • Images
    • IP Tracking
    • MedDRA
    • Queries



  • Multiple modalities
  • Study-specific, multi-user collaborative workflows
  • Traceability and transparency
  • Tagging capabilities allow users to flexibly organize and search for images
  • Manage processed or derived images
    • Link derived images to source images to establish provenance across modalities
    • Visualize and navigate using inheritance trees
    • Multi-file upload, linking and tagging
  • Improved reporting and tracking of workflow inventory and performance metrics

Images - Menu

Images - Seach

Images - Batch Upload, Linking and Tagging

Images - Amyloid Pet Workflow

Images - Hierarchy

Images - Metrics

Release Schedule

  • Launched on FYN
  • Plan to upgrade in the next 6 months:
    • A4 / LEARN
    • INI
    • TCAD

IP Tracking


  • Cleaner, more intuitive interface
    • Configurable data per menu
    • Smart action links
    • Additional details…
  • Advanced filters
  • Color statuses
  • New “Cart” interface
  • Automated drug ordering/resupply
  • Additional new features based on user feedback
    • Download CSV
    • Status report (interactive chart report)

IPT - Menu

IPT - Cart

IPT - Status Report

Release Schedule

  • Launched on FYN
  • TCAD - May, 2015
  • INI - ?



  • Support for MedDRA updates
  • Text-based search and filtering
  • Improved batch actions (coding and confirmation)

MedDRA - Menu

MedDRA - Batch Coding

Release Schedule

  • Launched on all active ADCS data portals!!!



  • Usability and Layout
    • All query related-information is visible
    • Modal vs drawer
  • More filters
    • Created-by
    • Touched-by
    • Query Age
    • Tags
  • Saved searches
  • Tagging
  • Starring - follow a query

Queries - Menu

Queries - Search

Release Schedule

  • Launched on FYN and CCF-RAS
  • Plan to upgrade in the next 6 months:
    • A4 / LEARN
    • INI
    • TCAD

How do we ensure that these changes are validated?

Validation 1.0

When any change (even a small change) is made to the software, the validation status of the software needs to be re-established.

General Principles of Software validation; Final Guidance for Industry and FDA Staff

Initial Validation

  • Completed in December 2012
  • Focused on Core Modules and Functionality:
    • Electronic Data Capture (EDC)
    • Queries
    • Audit Trail
    • Data Export
    • Document Repository
    • Authentication and Authorization
    • Meta-data Management

Initial Validation

  • Initial timeline: 3 months
  • Actual time to completion: 9 months
  • Traditional approach
    • Manual test execution
    • Paper-based
  • Required 50k+ person hours

Initial Validation

  • Observations:
    • Traditional approach is resource intensive and difficult to replicate
    • Our user community demands constant innovation
    • Our business requirements are evolving and study-specific
    • By design, we have a key dependency on web browsers, which are rapidly changing

"Timeline of web browsers" by I, ADeveria. Licensed under CC BY-SA 3.0 via Wikimedia Commons

Rapid Change in Browsers

Browser Share on Data Portals (Q1 2015)

Browser Usage on Data Portals (6 months to 3/31/2015)

Initial Validation

  • Conclusions:
    • Develop a new approach that effectively combines processes, standards and technology to maintain a continuous, documented, reproducible, and structured quality review of our clinical trials data management system
    • Furthermore, this new approach should allow us to rapidly validate new functionality and browser versions

Automated Validation

Software Development Life Cycle

  • Request
  • Approval
  • Design
  • Specification
  • Requirements
  • Development
  • Testing
  • UAT
  • Release
  • Configuration
  • Deployment

Software Development Life Cycle

  • Request
  • Approval
  • Design
  • Specification
  • Requirements
  • Development
  • Testing
  • UAT
  • Release
  • Configuration
  • Deployment


  • Git (Version Control)
  • Github (Cloud-based Version Control Service)
  • Jenkins (Task Queue)
  • Amazon Web Services (Platform as a Service)
  • Robot (Automated Functional Testing)
  • Foreman + Puppet (Provisioning and Configuration Management)
  • Spacewalk (Package Management)


  • Manage and test all software and system deliverables on a ongoing basis
    • Reproducibility
    • Flexibility
    • Scalability
    • Visibility
    • Metrics
  • Testing becomes central to the overall development process


  • We completed development of the automated validation framework in July 2014
  • We completed the first round of automated validation activities in December 2014
  • We achieved full coverage of all Data Portal apps in March 2015


  • The following tests are running nightly:
    • 1k+ Functional Tests
    • 8k+ Unit Tests
  • The functional tests are running in Chrome and Firefox
  • We plan to continue to expand our test coverage

Request Management

Testing Command Center

Unit Testing Reports

Functional Testing Reports

Robot in Action



  • Improvements to the Help app
  • Working on with LONI to add ADCS data to GAAIN
  • Preparing for A5 and future studies
  • Developing new approaches to integration of external data and data sharing
  • Working with Safety Stats on RBM
  • Working with Stats on Reporting
  • Working with Biomarker on LIMS

Thank You