Appendix_D_-_Introduction_to_NIMS.ppt

Introduction to NIMS A Computational Science Center (CSC) Course Offering

Agenda 1.) Introduction 2.) What you can do with NIMS 3.) Online training module 4.) Training & support 5.) Next steps

1.) Introduction 2.) What you can do with NIMS 3.) Online training module 4.) Training & support 5.) Next steps

Introduction Please write questions on index cards; you will have the opportunity to ask questions at the end.

Please complete the electronic evaluation you will receive after the class – we need your feedback!

Introduction > NIMS Training Curriculum

This diagram shows the major components of the NIMS training and introduction at FDA that helps reviewers learn to use the tool effectively.

This is the introduction course, which includes a reference card and question and answer session at the end. After completing this course, reviewers have access to the NIMS tool, which has the online module, a user guide, quick reference guide, use cases, and FAQ housed within the tool for your convenience. User Support is also available as soon as the reviewer has access to the tool and is ready to begin using NIMS.

Introduction > Learning Objectives By the end of this class each participant will

1. Understand how NIMS fits into CDER regulatory review strategy

2. Understand how NIMS will save you time and provide dynamic visualization and analytic capabilities for review

3. Understand how to access and navigate through the online training module and other training materials when you need them

4. Understand what kinds of user support are available for NIMS and how to access them

These learning objectives state what you should expect to get out of this introduction course.

CDER vision Put the relevant information at the fingertips of the reviewers for analysis & decision making.

CSC-OND Collaboration on NIMS

PDUFA Implementation

Summary Methods Interpretation Data tabulations

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Data tabulations SEND xpt Summary Methods Interpretation

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1.) Introduction 2.) What you can do with NIMS 3.) Online training module 4.) Training & support 5.) Next steps

NIMS can save you time and help you do an effective review by providing you data in a standard but dynamic way.

… Here’s how:

Instructor will provide a live demonstration of the NIMS tool to the class at this time.

Study Activities view

The Study Activities View provides a high-level view of the key activities and events on the timeline of the study in Gantt format.

Study Activities view

This shows Study Activities View drilled down to individual subject level.

Trial summary in reviewer template

The data from the Trial Summary section and other domains are exported into pre-defined FDA specified Reviewer Template.

z-transform box-plots for laboratory results

Z-transform view allows users to review all clinical pathology findings in a single view.

Histopathology findings with incidences drilled down to subjects

The Consolidated Incidence View for histopathology findings displays incidence counts for observations across treatment groups, tissues and study days. It allows users to drill down to individual subjects that contributed to the incidence count.

Export histopathology data to reviewer template

The incidence data from histopathology findings can be exported to standard reviewer template format.

Group summary

The means that standard deviation and percent difference when compared to the reference group across treatment groups and days are displayed in the Group Summary view for each parameter.

Individual Subject Profile

Individual Subject profile consolidates all the findings for the selected subject across data domains in a single view.

Charting capabilities

ToxVision allows users to view study data in various graphical representations from the Group Summary and Individual Results tabs.

Data export capabilities

ToxVision allows users to export study data into various formats like Excel, CSV, Word, XPT,XML and Prism from the Menu option on all views.

Combining groups for analysis

ToxVision allows users to select two or more groups or sets from Trial Sets domain and combine them into a single virtual group for analysis.

Combining groups for analysis: Results

Setting reference / baseline groups

Users can set the baseline for any available group to perform intergroup comparison.

Exclude /include subjects from analysis: Results

The group summary (Means and Standard Deviation) can be recalculated by excluding an outlier for a subject within a treatment group.

1.) Introduction 2.) What you can do with NIMS 3.) Online training module 4.) Training & support 5.) Next steps

Online training module The Online Training Module teaches you how to perform review tasks in NIMS.

It can demonstrate lessons for you You move through at your own pace

The online training module covers:

[Continued]

Online training module > Sample Lessons

Live Demo

Lesson: Study Activities View

The instructor will provide a live demonstration of navigating through two tasks in the NIMS tool.

1.) Introduction 2.) What you can do with NIMS 3.) Online training module 4.) Training & support 5.) Next steps

Training & Support CSC NIMS Training Website:

http://inside.fda.gov:9003/ProgramsInitiatives/Drugs/ComputationalScienceCenter/ucm330339.htm

This diagram shows the training materials and support available to reviewers both within the NIMS training curriculum and as extra help as needed.

Training & Support within the tool

NIMS User Support

This chart shows the NIMS support services (email addresses or websites with extra resources) that are available to reviewers at any time.

1.) Introduction 2.) What you can do with NIMS 3.) Online training module 4.) Training & support 5.) Next steps

Next steps > Access to NIMS

You will receive an email with login information and the NIMS shortcut after the training.

Next steps > Your Feedback The CSC is dedicated to making NIMS as valuable to you as possible. We need your feedback to reach that objective.

Contact the CSC with any ideas or suggestions you have: CDERCSC@fda.hhs.gov We will be reaching out to users for a focused evaluation in the future.

Next steps > Course Evaluation You will receive a link to an electronic evaluation of this course within the next two weeks.

We appreciate you completing the evaluation to help us make improvements.

The electronic evaluation should only take a few minutes to complete. Your feedback is valuable to the CSC.

The CSC Training Development Team would like to thank everyone who helped us shape this course

Questions & Answers