# Presentation: 683120

## CTMS Workspace Call

***caBIGTM Clinical Trials Management System Workspace Monthly Meeting***
***February 26******th******, 2008***

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## Program Updates

**Next CTMS Face-to-Face Meeting: **April 29-30, 2008
- University of New Mexico, Albuquerque
- Registration Link:
- https://cabig.nci.nih.gov/eventmanager/CTMS_f2f_4-29-2008
**Official Release: caBIG****TM Clinical Trials Suite ****1.0**

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## cancer Biomedical Informatics GridTM (caBIGTM) Deployment Overview

**cancer Biomedical Informatics GridTM (caBIGTM) Deployment Overview**

**Mark Adams, Ph.D.**
- Chief Scientific Officer (caBIGTM)
- Booz Allen Hamilton

## Setting the Stage: Key Concepts

- To connect with caBIGTM, we need tools (e.g., software applications) that are caBIGTM-compatible – meaning they can interoperate with other caBIGTM tools to achieve the benefits described above.
- We become caBIGTM-compatible when we either _**adopt**_ a tool from caBIGTM or when we _**adapt**_ our own tool to be interoperable (and therefore compatible) with other caBIGTM tools.
- In addition to adopting or adapting tools, we will also connect to the caBIGTM infrastructure backbone – called caGrid (or “The Grid”). This is called “establishing a Grid node” (or, “getting on the Grid”).
- Once connected to others through the Grid, we are able to access caBIGTM-compatible tools and data sets at other organizations, and can offer ours to others as appropriate.

## Two Pathways – Adopt or Adapt 

**Adopting** a tool involves installing software applications already created by caBIGTM, integrating them into our workflow, and connecting to caGrid.
**Adapting** a tool involves modifying our existing software applications to be caBIGTM-compatible,  and then connecting to caGrid.

- Interface from Our Tool to the Grid

## Determining the Best Path

**Determining the Best Path**

- _Adopting_ may be best _if_...
**caBIGTM tools fulfill our needs in the domains of clinical trials, molecular research, imaging, and/or biospecimen banking **
**End users are open to learning new tools and integrating them in their workflow **
**Our technical teams are not available or able to build or reengineer software, but we can leverage internal resources to support a software installation effort**

- _Adapting_ may be best _if_...
**Our existing technology infrastructure and tools meet the needs of the users, and are already integrated into workflows**
**Our technical team has software development expertise and experience with the NCI’s vocabulary and data model tools/repositories****  **

***We might choose a hybrid approach:**** ****adopting**** one or more caBIGTM applications *_***and***_* ****adapting**** some or all of the existing applications.*

## How Do I Adopt Tools? 

**We can adopt as many or as few tools from the bundle as we want, based on our existing tools and our identified needs. **
**To choose to adopt, we need to engage decision makers and end users to establish how tools might benefit research efforts, how tools might integrate with existing workflows and processes, and how tools can be leveraged across our institution.   **
**Accessing and installing caBIGTM tools will require technical teams that can install and integrate the tool into our infrastructure.  Most caBIGTM tools require open source supporting software. Some tools will have hosted options, if we don’t want to install them here.  **
**Critical factors influencing our adoption decision include:  tool functionality, usability, and implementation logistics (such as data migration from existing legacy systems).  Our self-assessment and capability report will help support these decisions. **

## How Do I Adapt A Tool? Steps to Compatibility

**How Do I Adapt A Tool? ****Steps to Compatibility**

**caBIGTM-compatibility begins with an **Information (or Data) Model**, which represents the interfaces and relationships of a system. **
**The information model is then annotated with **Controlled Vocabularies** to establish shared meaning across model components (called “semantic integration”). **
**This annotated information model is then converted into **Common Data Elements (CDE’s)** that provide the structure (or format) for the data.  **
**The information model is also used to generate the **Application Programming Interface (API)**: the mechanism by which data are exchanged. **

- These four elements are called **compatibility criteria**.  If each is created correctly, we have a caBIGTM-compatible tool.

## Adapting is a Complex Process With Investment Implications

- Investments are required to adapt a tool to be caBIGTM-compatible – the cost depends on the complexity of our tool, and the degree to which a data model already has been defined.
**Staffing – **Achieving caBIGTM compatibility requires technical and domain teams.  The technical team may include a mix of application developers, data modelers and curators, and database administrators.  The domain team represents the scientific research realm that the tool supports.
**Tools – **The National Cancer Institute (NCI) provides a set of tools to support the compatibility development process, as well as a controlled vocabulary repository, and a metadata repository. Previous experience with these tools will facilitate the adaptation process – a training curriculum is available to new users.
- We do not have to reengineer an entire tool to become caBIGTM-compatible – there are many alternative approaches.

## Alternative Approaches toAdapting a Tool

| Option | Operating Scenario | Recommended Solution |
| --- | --- | --- |
| 1 | We have a paper-based system or a homegrown tool that would not be painful to abandon. | ADOPTION OPTION:  Adopt caBIGTM tool, and migrate existing electronic data to new tool.  |
| 2 | We have an existing basic tool that we want to keep.  Examples: Tool built in Access or mySQL database.   | Become caBIGTM-compatible by installing a caBIGTM tool that serves a similar function, and then map our tool to it. We connect from our tool to the Grid through the caBIGTM tool.   |
| 3 | We have existing tools - more complex than a simple database, with separate modules for reporting and storage (e.g., standard reports are a small extract from a larger system).  | Make the existing tool caBIGTM-compatible for standard reports only.  Data generated in required reports would be caBIGTM compatible; the remaining data need not be.  |
| 4 | We have an existing complex informatics tool (like Option 3), but our reporting needs vary greatly, and we would like to have the entire system caBIGTM-compatible for maximum flexibility.  | Make the full tool compatible, by creating an interface that maps the existing tool’s data structures to caBIGTM standards.  This is the highest investment solution, but may provide the greatest payoff. |

## Getting Started with Adapting a Tool 

**Adapting a tool to be caBIGTM-compatible requires collaboration by both research domain and technical development representatives – this team will set goals and approach.  The **_**[caBIGTM Compatibility Guidelines](https://cabig.nci.nih.gov/guidelines_documentation)**__** describe the compatibility criteria in more depth. **_

## Summary: How It All Fits Together

**Summary: ****How It All Fits Together**

## Determining the Forward Path

**Determining the Forward Path**

**Next Steps:**** **
- Determine target research domains across the institutions for connecting with caBIGTM - driven in part by the kinds of data you are willing and able to share with others who are connecting.  This data sharing should occur across your institution, as well as with others.
- Identify the team that can drive adopt-adapt decisions in those domains across the Center, with the goal of driving meaningful research collaboration across the institution and with others.
- Establish goals and a path to implementation.

**Determining the specific path to connect with caBIGTM will require collaboration and involvement by domain decision-makers, end users, technical experts, and policy team members.   **

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## cancer Biomedical Informatics GridTM (caBIGTM) Deployment Update

**cancer Biomedical Informatics GridTM (caBIGTM) Deployment Update**

**Susan Varghese**
- caBIGTM Deployment Advisory Center Lead
- Booz Allen Hamilton

## Getting Connected with caBIGTM

**Who all are *****Getting Connected*****?**
- 43 (+3) of 63 NCI Designated Cancer Centers
- 10 of 16 NCI Community Cancer Centers
**What do you have to do to *****Get Connected*****?**
- Assess where you are (Self-Assessment)
- Determine where you want to be (Center caBIGTM Goals)
- Develop a plan to get there (Implementation Plan)
- Implement caBIGTM infrastructure and tools

## The Road Map  

|  | Where is your Center now? | Where does your Center want to be? | How will your Center get there? | When will your Center get there? |
| --- | --- | --- | --- | --- |
| Process* | Complete Self-Assessment | Define Center caBIGTM Goals | Develop Implementation Plan | Implement caBIGTM Infrastructure and Tools |
| Target Date** | November 2007 | Mid-February 2008 | Mid-April 2008  | Post- April 2008 |

- *   Self-Assessment to Implementation takes approximately six months
- **  Timeline applies to those NCI-designated Cancer Centers that submitted their Self-
-      Assessment by November 30, 2007

## Self-Assessment Questionnaire

## Center Status:  Self-Assessment  

**Center Status:  Self-Assessment  **

## Center caBIGTM Goals Document

- Executive Summary of Center caBIGTM Goals
*Getting Connected with caBIGTM* Mission Statement
- Benefits of caBIGTM Implementation
- Relevant caBIGTM Implementation Opportunities
- caBIGTM Implementation Goals
- Managing Capabilities and Potential Challenges for caBIGTM Implementation

## Center Status:  caBIGTM Goals 

## Next Steps  

|  | Where is your Center now? | Where does your Center want to be? | How will your Center get there? | When will your Center get there? |
| --- | --- | --- | --- | --- |
| Process* | Complete Self-Assessment | Define Center caBIGTM Goals | Develop Implementation Plan | Implement caBIGTM Infrastructure and Tools |
| Target Date** | November 2007 | Mid-February 2008 | Mid-April 2008  | Post- April 2008 |

- *   Self-Assessment to Implementation takes approximately six months
- **  Timeline applies to those NCI-designated Cancer Centers that submitted their Self-
-      Assessment by November 30, 2007

**We are here**

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## Case Study Introduction

- Purpose
- “Case Studies” are based on aggregate results of the self-assessments submitted to date.
- Includes one adopt case, one adapt case and one hybrid case.
- As a group, we will discuss the case and identify key areas to consider.
- Anyone who has experience with a similar case should share their lessons learned – positive or otherwise.
*But first, some general Q&A about caGrid and adapting which may serve as useful background...*

## Requirements

**What is required in order to set up a caGrid node and share clinical data?**
- The easiest way to share data on the caGrid is through one of the Grid-enabled applications in the caBIGTM Clinical Trials Suite. You will need to install a local caGrid node at your local institution, and then make use of specific caGrid-enabled applications. By loading local data into the local application, the data can then be made available on the Grid.
- Installing a caGrid node creates local infrastructure required to allow specific Grid Services to be placed at your site
- For clinical data, a tool like CTODS (Clinical Trials Object Data System) can be used to aggregate and host specific data for communication on the grid
- The standard caGrid security infrastructure can be used to regulate access to users and groups who are allowed to view the specific data sets
- Note that it is possible to install all the caGrid infrastructure for purely *local* data sharing with sensitive data such as identified patient information, but that is more complex and requires more effort than a standard caGrid installation
- The applications vary with respect to the level of difficulty for installing and testing.

## Adapting Specific Systems

**	****How can existing locally-developed and/or commercial systems (such as Oncore or Epic) be used in conjunction with caBIGTM?**
- The answer will be highly dependent on your institution’s specific tooling, capabilities, interests, and business/vendor relationships
- For a center that has clinical data to share, a relatively straightforward approach can be to develop extract, transform and load (ETL) scripts from an existing clinical data store, map that data to the caBIG-standard data elements, and place the data in a caBIG-compatible data repository such as CTODS.
- Similarly, a tool such as caXchange could be used to take industry-standard data streams in the form of messages (or even ASCII files) and transform the information into caBIG compatible data which can then be placed in a caBIG compatible data repository such as CTODS to provide access
- Many other possibilities exist, such as developing caBIG compatible application programming interfaces (APIs) on top of existing systems, but this requires specific capabilities or experience in the institution or its subcontractors.

## Adaptation Requirements

**	****Does adaptation require using caCore to convert a system into one that is caBIG compatible (by registering concepts and entities with the caDSR, etc.)?**
- Adaptation can take many different forms, depending on the skills, requirements and needs of the participating institution.
- In general, adaptation just means that the existing systems are provided a means to place designated data where it can be shared using caBIG standards and infrastructure
- This can include using caCORE and other caBIG tools to directly provide caBIG compatible interfaces on existing tools. The tools exist, and have been tested and used throughout the program by a variety of different institutions, but they can require effort and specific experience which may not exist at all centers.
- A possible solution is to work with service providers that have experience with the tools, and can help get your institution up to speed with the systems quickly.

## General Costs/Time for Adapting

**	****What are the costs and general timeline for adapting pre-existing in-house software?**
- This will vary significantly based on your own institutions existing infrastructure.  By comparing the specific requirements for the caGrid components to what your own institution already supports as a standard part of running its business, you can get an estimation of the specific costs.
- The deployment support center can also help locate and identify any additional information you would need to develop these estimates, and put you in contact with those who can supply specific needed information
- We are working on a set of “design patterns” that should serve to provide some general guidance in helping each institution come up with implementation plans that reflect the unique nature of their respective sites.
- There are a range of existing processes and models within the program that you can leverage to provide a framework for your own local efforts.

## Costs for Managing a Grid Node

**	****What is the cost of maintaining a caGrid node?  What type of FTE and % effort is required?   **
- This will vary by institution and by the applications supported at the site.
- Once system is installed and running, effort and cost should be minimal except for upgrades and basic maintenance of the configuration and core tools:
- caGrid Version
- Browser
- Database
- Jboss App Server
- JSDK
- Apache Ant
- Apache Axis

- Hibernate
- Common Security Module
- caCORE SDK
- caCORE
- Globus Tookit
- Tomcat
- HTTP Server

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## Case Study One:Adopting caAERS

**Scenario****:**
- No single standard tool at the institution for tracking adverse events
- Some limited tools which are not caBIGTM compatible (mostly spreadsheets, paper forms and local Access databases)
- Having caBIGTM compatible systems is a moderate to high priority for the institution
- Minimal internal programming resources
- Desire to track and report adverse events more consistently and easily across the institution

## Case Study One – Adopting: Discussion Questions

**Considerations are similar to implementation of any new software:**
- Staffing
- Project management
- Key users
- Hardware
- Dependencies
- Budget
- Training
- Existing Infrastructure – firewalls
- Data conversion
- Data sharing
- Security

## Case Study Two:Adapting a Participant Registry

**Scenario****:**
- There is a single standard tool at the institution for registering and tracking participants across studies
- The tool is well-understood by local I.T. development/support staff
- The tool is well-liked by users and has rich functionality and a large store of existing historical data
- Having caBIGTM compatible systems is a moderate to high priority for the institution
- Available internal programming resources with appropriate skills
- Desire interact with caBIGTM compatible systems at local site (such as Study Calendar) or other institutions (such as a coordinating center)

## Case Study Two – Adapting: Discussion Questions

**Considerations are similar to adopting, but:**
- Generally more complicated than adopting, though may have specific benefits for your institution
- Local technical expertise or available contractors
- software development
- supporting/enhancing installed applications
- NCI’s vocabulary and data model tools/repositories
- Probably no need for data import/conversion
- May need data export for sharing (e.g., to CTODS)

## Hybrid Approach: Discussion

- A reasonable approach if there is a longer-term plan to adopt a particular tool or while vendor is working on compatibility, but there is a shorter term desire to interoperate with other caBIGTM sites or components
- Has elements of both adapt and adopt approaches that need to be considered
- caXchange should be considered for exchange of messages
- CTODS could be used for exporting specific data from existing system to share
- Benefits
- Risks

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## Agenda

**Welcome & Agenda Review**
**Program Updates**
**caBIG Deployment Overview**
**Deployment Update**
**Case Studies Activity - Introduction **
**Case Studies Activity**
**Community Involvement**
**Closing Remarks & Next Month’s CTMS Workspace Meeting**

## Thank you!