# Presentation: 408854

## caAERS: Functional Deep Dive 

***CTMS Face-to-Face***
***May 31, 2007***
***Presented by:***
***Edmond Mulaire, Ph.D.***
***Ram Chilukuri***
***SemanticBits, LLC, MS***

## Outline for Today’s Presentation

**Overview (15 min)**
- The caAERS Project (5)
- The caAERS Application (10 min)
**Demonstration (40 min)**
- Creating an Expedited SAE Report
- Creating Routine AE Reports
- Creating Rules and Setting up a Report Calendar
- Setting up a Study
**Technical Design (10 min)**
**Questions (10 min)**

## THE CAAERS PROJECT

**A 5-Minute Overview**

## The caAERS Team

**The caAERS Team**

**Lead Architects **
- Ram Chilukuri1
- Vinay Kumar1

**Developers:  **
- Krikor Krumlian3
- Visu Patlolla1
- Biju Joseph1
- Richard Jenkins3

**Analyst**
- Sean Whitaker2

**Domain Experts**
- Warren Kibbe, Ph.D.2
- Renee Webb, RN2
- David Patton2
- Brenda Martone, MD2
- Cal Collins3

**Lead Developer: **
- Rhett Sutphin2

**Adopters**
- Mayo Clinic: Sharon Elcombe, Sonja Hamilton, Larry Esser
- Wake Forest: Bob Morrell, Kim Livengood, Steven Cheng

**Project Manager**
- Edmond Mulaire1

**Technical**

**Functional**

- 1. SemanticBits    2. Northwestern University    3. Akaza Research

- = Development Team

- = Contributors

## Project Timeline

- 10.5 Months – Start to End
- Kicked off project in December
- Production quality version to be released in September
- Followed by 1.5 month Transition period

## Project Approach

- Iterative and Incremental

## Project Methodology

**BDUF – Big Design Up Front**

**BBD – Big Bang Delivery**

## THE CAAERS APPLICATION

**10 Minute High-Level Overview of Use Cases and Features**

## caAERS in a Nutshell

**Adverse Event Reporting System**
**Supporting Cancer Clinical Trials**
**Web-Based UI**
**Database-Driven**
**BRIDG Compliant**
**caBIG Silver Level Compatible**

## caAERS – Key Functionality

## Modules and Use Cases

## Vocabularies and Code Sets

*Italics = may not be in scope for this release*

## Import and Export of Data

**Three Interfaces Supported**
- Manual Entry (i.e., keying in data)
- Public APIs -- for Programmatic Access
- Flat File (XML)

**Similarly, sites will be able to import data from CTEP (PATS) or other systems.**

## Usability and Accessibility

- Intuitive look-and-feel
- Wizard-driven workflows
- Summary information provided where needed
- Online help
- Google-like, auto-completer search functionality
- Few pop-ups
- Use of AJAX technology to minimize page refreshes
- 508 Compliance

## Security

**Role-based**
- Study Coordinator
- Participant Coordinator
**.**
**.**
**.**
- System Administrator
- SuperUser
**Leverage caBIG Security Modules/Infrastructure**
- CSM (Common Security Module) for local security
- Grid services
**Other Security Features**
- SSL – To encrypt data transmitted over Internet/Intranet
- Passwords – Encrypted, Reset Feature for Forgotten Passwords
- Comprehensive Audit and History

## System Requirements

**Server-Side**

**Client-Side**

## Supported Configurations

- Stand Alone

- Integrated with Local Applications

- Local caAERS Systems will be able to exchange data

## Integration with CTMS Suite

**Lab Viewer**

- Identifies labs, loads them into the CDMS and AE system

- Clinical data is captured

**Integration with CTMS Suite**

- Eligibility is verified and patient is registered to a study

**Cancer Central Clinical**
**Participant Registry (C3PR v2)**

- Tracks the patient throughout the study

**Patient Study Calendar            **
**(PSC)**

**Clinical Trial Data**
**Management Systems (C3D)**

**Cancer Adverse Event**
**Reporting System (caAERS)**

- Identifies AEs and any associated schedule changes

## In Scope / Out of Scope

**In Scope / Out of Scope**

**In Scope**

**Out of Scope**

## Features Not Implemented Yet

**Rules Engine**
- Hooking rules engine into AE Data Capture Flow
- Institutional Level Triggers and Notifications
- Improvements to Rules Authoring UI
**Data Capture Screens**
- Radiation Intervention
- Surgery Intervention
- Devices
**Implementation of DCP Data Capture Flow**
**Solicited AE’s UI**
**Advanced Search Functionality**
- Search for AE’s by MedDRA code
- Search for AE’s by CTC code
- Search for AE’s by Study

**Submitting Reports**
- UI for submitting reports
- Capture PI signoff
- caAERS to AdEERS electronic submission and handoff
- Coded Reports.
- Saving as PDF
- Printing
- Submittal history UI
**Exporting AE Data**
**Roles**
- Defining list of  roles
- Setting up security policies for the set of out-of the box roles for caAERS
**Audit**
**Online Help and Onscreen Instructions**

## LIVE DEMO

## Task Menu

## Demo 1 – Creating an Expedited AE Report

- An Event happens.
- CRA determines it’s an SAE and requires expedited reporting
- CRA enters Expedited Report in caAERS. Saves as pending.
- CRA receives notifications sent by caAERS/Rules Engine
- A few days later, CRA opens pending report, completes and submits.

## Protocol – Used in Demo

**Official Title**: Infusional Chemotherapy in Previously Untreated Patients With Intermediate Or Aggressive Non-Hodgkin's Lymphoma: A Study of Dose-Intense Therapy With Cytokines. Part I: G-CSF 3/02 Dose Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
**Short Title**:  Combination Chemotherapy NHL
**Study ID Numbers**:  CDR0000078293; NCI-93-C-0133; CRB-9307; NCI-MB-303; NCI-T93-0023N, NCT00018980, NCT00001337
**Description**: This phase II trial is studying giving rituximab and filgrastim together with combination chemotherapy to see how well it works in treating patients with non-Hodgkin's lymphoma.
**DEMO  ASSUMPTIONS:**
- Study already setup in caAERS.
- Subjects Assigned.
**EVENT:**
- Primary AE: Bone Ache, grade 4, unexpected – attributed to filgrastim
- Neutrophil, expected, grade 3 – attributed to R-CHOP regimen / chemotheraphy
- Swelling  -  grade 2, attributable to Disease
- Pain in neck – grade 2, attributable to disease
- Fever, grade 2:  attributed to other contributing causes: flu

## Creating an expedited report

**Creating an expedited report**

**4a.   **AE is saved to DB

**Switch to Demo**

## Submitting expedited report to AdEERS

- Initiates Report in caAERS

**CTEP**

- Rules Engine Confirms that this is an SAE. **Clock is started**.

- Email sent to CTEP to notify and synch clock

- Notifications sent per rules

- Completes
- Report

- Submits Report

**AdEERS**

- CRA

- Rules Engine

- Reads Notifications

**[Switch to demo]**

## caAERS to AdEERS Communication

**caAERS to AdEERS Communication**

- 1. Submit report

- 2. If report valid, send ticket number.
-     If not valid, send list of errors.

** **
**Enterprise **
**Service **
**Bus**

## DEMO

**Demo Scenario 2**
- Series of AE’s observed
- CRA determines they are routine and don’t require expedited reporting
- At some point, e.g., end of month, CRA enters routine AE reports into caAERS

**Demo Scenario 3**
- Create a study-level rule

**Demo Scenario 4**
- Creating a study by keying in data

**Demo Scenario 5**
- Creating Study by importing study abstract data

## Technical Overview

## Modules in caAERS

- caAERS

- Grid Services

**Modules in caAERS**

## Layered Architecture

## Rules Module

## Rule

## Scheduler

- Rules Engine

- Notifications

## Rules Implementation

**JBoss Drools**
- Open source
- JSR 94 Compliant
**Rules Repository**
- Jackrabbit with PostgreSQL/Oracle
- Open source Java Content Repository (JCR) implementation

## Notification

## Time Scale_x0003_

- Event

- Day

- Notification

- When ?

- Hour

- Minute

- Second

## Define content of the notification

- Notification

- What ?

- Subject Line

- Body Content

- Attachment

- Format

- Content Definition

## List of recipients

- Notification

- To Whom ?

## Application of Template

- Report and
- Notification
- Schedule

- Notification

- Notification

- Notification

- 1

- 2

- 3

- 4

- Time Line

- Scheduler

- SAE Report

- Rules Engine

- Report Calendar
- Template

- 5

## Wrap Up

## Key Remaining Features

**Rules Engine**
- Hooking rules engine into AE Data Capture Flow
- Institutional Level Triggers and Notifications
- Improvements to Rules Authoring UI
**Data Capture Screens**
- Radiation Intervention
- Surgery Intervention
- Devices
**Implementation of DCP Data Capture Flow**
**Solicited AE’s UI**
**Advanced Search Functionality**
- Search for AE’s by MedDRA code
- Search for AE’s by CTC code
- Search for AE’s by Study

**Submitting Reports**
- UI for submitting reports
- Capture PI signoff
- caAERS to AdEERS electronic submission and handoff
- Coded Reports.
- Saving as PDF
- Printing
- Submittal history UI
**Exporting AE Data**
**Roles**
- Defining list of  roles
- Setting up security policies for the set of out-of the box roles for caAERS
**Audit**
**Online Help and Onscreen Instructions**

## caAERS Project Documentation

**Document Repository – GForge:**
- _[http://](http://gforge.nci.nih.gov/projects/caaersappdev/)__[gforge.nci.nih.gov/projects/caaersappdev](http://gforge.nci.nih.gov/projects/caaersappdev/)__[/](http://gforge.nci.nih.gov/projects/caaersappdev/)_

## Questions

## Contingency Slides