# Presentation: 873862

## Janus/CRIXClinical Data Repository (CDR)

**Janus/CRIX****Clinical Data Repository (CDR)**

**Project Overview for CRIX Executive Group**
- June 30, 2005

## Agenda

- Background (Review)
- Goals and Objectives
- The Vision
- What is the Janus/CRIX CDR?
- Pilot Project Overview
- Project Approach
- Project Activities and Deliverables (In-Scope/Out-of-Scope)
- High Level Timeline and Deliverables
- Project Organization, Roles and Responsibilities
- Working Groups Today

## Purpose and Expected Outcomes

**The purpose of this Janus Project Overview is to:**
- Provide project introduction and outline overall goals of this project
- Discuss project team member roles and responsibilities
- Review high-level project approach:  key tasks, deliverables and timing
- Start defining requirements
**The expected outcomes are:**
- Facilitate communication
- Common understanding of processes that will be followed to achieve project success
- Shared expectations regarding project’s goals and and commitment to achieving the overall goals of this project
- Initial list of use cases and requirements

## CRIX Objectives (Reminder)

- More efficient submission based on standards
- Reproducible, custom datasets for analysis
- Reusable tools for analysis and review
- Less data redundancy
- Less time on orientation to data by reviewers
- Less ambiguity in communications of information
- More auditable data
- Less manual, paper processing
- Use of common standards across the entire community (government, industry, academia)
- Interoperability with other caBIG data sets, tools, capabilities

**NO MORE PAPER!**

## CRIX Vision (Reminder)

- An infrastructure that will:
- allow secure transmission of clinical research information between sponsors, researchers, and regulatory authorities;
- facilitate the adoption of electronic data standards, standardized terminologies, e-transactions, and e-submissions;
- reduce the overall cost of existing information gathering and submissions development processes as well as review and analysis of information; and
- be accessible to all.

## CRIX Development Projects

- Firebird
- Global investigator registry for commonly used/referenced data
- SAFE
- Legally enforceable digital signatures compliant with Title 21 Regulations
- CRIX CDR (Clinical Data Repository)
- Sustainable, secure and standards-based repository for electronic IND submissions of data and documents
- Tools for reviews, reporting and analysis
- Electronic IND Submissions
- Sustainable, secure and standards-based infrastructure for electronic submissions of data and documents

## CRIX Development Plan

**CRIX Development Plan**

**Firebird/SAFE**

**CRIX CDR**

**Electronic**
** ****Submissions**

**technical****feasibility**

**operational****feasibility**

**...**

**...**

**Production****Infrastructure**

**Infrastructure ****Development**

**Firebird/SAFE**

**Firebird/SAFE**

**CRIX CDR**

**CRIX CDR**

**Electronic **
**Submissions**

## CRIX 2.0: Clinical Data Repository (CRIX CDR)

- Partnering with industry to:
- Implement a prototype a Clinical Data Repository that is standards-based and caBIGTM compliant
- Develop a data import facility that accepts data in standard formats
- Provide a data services layer that supports collaborative research for multi-site studies on a global basis
- Provide tools for review, analysis and reporting

## Janus/CRIX Scope*

- What’s in
- All clinical trial data
- Protocol
- Analysis plan
- Animal tox data

- What’s out
- Spontaneous reports
- Documents
- Reviews

****Pilot includes implementation of existing Janus data model defined under IBM CRADA with FDA only***

## Janus/CRIX Functional Building Blocks

- Data – “what happened”
- Findings
- Events
- Domains, attributes
- Interventions
- Protocol – “what was supposed to happen”
- Trial structure (arms, visits)
- Planned assessments
- Like actual findings, but no result
- Planned interventions
- Like actual interventions
- Analysis plans and results
- Analysis datasets (query rule)
- Analytic plans
- Analytic results

## Out of Scope for Janus/CRIX Pilot:Potential Extensions

- Implement the data services layer for the _entire_ Janus/CRIX model
- Implement a fully validated, complete Janus/CRIX Model that is compliant with CFR 21 Part 11
- Conduct performance analysis of Janus/CRIX repository to project expected production scale system requirements and identify any performance constraints
- Extend the Janus/CRIX data model so as to support data now gathered in the CDUS and CTMS applications managed by NCI’s Cancer Therapy Evaluation Program (CTEP) as well as for SAEs, AdAM, and 1571/1572 form information

## CRIX CDR - Data Access Vision

**Tools for Review, Analysis, Reporting**

**Ad Hoc**
**Query**
**Tool**

**Spread-**
**sheet**
**Tool**

**Master Index**

**Janus**
**Extensions**

**Base Janus Model**

**CRIX CDR**

**FDA**
**Review**

**SAS**

**WebSDM**

**ToxVision**

**I-Review**

**Study Specific Data Marts**

**...**

**Data Access Layer (CDISC/HL7)**

## CRIX CDR: Collaborative Research Environment Vision

**Clinical Center**

**Clinical Center**

**NCI**

**Grid/Web Services:**
**Security Services (CSM+)**
**Semantic Services (caDSR)**
**Vocabulary Services (EVS)**
**Data Services (caBIO)**
**etc.**

**Virtual**
**Database**

**Biopharma**

**CRO**

**Local**
**DBs**

**Local**
**DBs**

**Local**
**DBs**

**Local**
**DBs**

**Local**
**DBs**

## CRIX 3.0: Electronic Submissions

- Develop and deploy a *secure*, electronic infrastructure for facilitating submissions to the FDA including:
**Documents:** unstructured text or non-standard, special data sets submitted via:
- ICH Electronic Common Technical Document (eCTD)
- HL7 Regulated Product Submission (RPL) message - under development
**Data:** Standard, structured data submitted via:
- ODM and SDTM Define.XML
- HL7 v3 Electronic Data Collection Instrument (eDCI) message – under development
- Proposal for submission of standardized electronic study data from clinical studies evaluating human drugs and biologics would revise FDA regulations to require clinical study data to be provided in electronic format and require the use of standard data structure, terminology and code sets – Federal Register 69 FR 73119

## Putting it All Together

**Putting it All Together**

- Annual Reports
- Investigator Brochures
- etc.

**Government, Academic or Industry Site**

**Documents ****(Unstructured Text &**
**Non-Standard Data Sets)**

**Structured Data**
**(Standard Data Sets)**

**CRIX**
**Clinical Data**
**Repository**

**Secure**
**Transport**

**Message**
**Exchange**
**Services**
**(ebXML)**

**Secure**
**Transport**

**Secure**
**Transport**

- Structured Protocols
- Findings
- Events
- Interventions
- etc.

**ODM and**
**SDTM Define.XML or HL7 eDCI XML**

**Data**
**Load**
**API**

**eCTD or **
**HL7 RPL XML**

**Message**
**Exchange**
**Services**
**(ebXML)**

**Secure**
**Transport**

## Janus/CRIX Project Organization

- Program Lead
- (S. Dubman)

- Executive
- Steering Group
- (IOTF Informatics
- Subcommittee)

- BRIDG/CTOM
- (C. Andonyadis,
- Scenpro)

- ebXML,
- HL7 SDK
- (S. Liu, SAIC)

- CDUS/CTMS
- Extensions
- Analysis
- (CTIS)

- Janus
- Pilot
- (IBM)

- FDA Lead
- (R. Levin)

- Technical
- Support
- (Terpsys)

- Analytical
- Tools
- (SAS, Lincoln,
- Pharmquest,
- I-Review, etc.)

- Relevant caBIG
- Workspaces
- and SIGs
- (CTMS, DSIC,
- V/CDE, Arch)

- CRIX Exec
- Steering
- Group

## Janus/CRIX CDRPilot Project Overview

- Bill Tulskie, IBM

## Development Team Assignments (Leads and Staff/SMEs)

- Project Manager: Ginny Wagner
- Architect: Bill Tulskie
- Requirements Team
- Lead: Kathy Martin
- Staff/SME: Elise Blaese
- Data Load & Data Warehouse Team
- Lead: Doug Del Prete
- Staff/SMEs: Joyce Hernandez
- Data Access Team
- Lead: Joel Dubbels
- Staff/SMEs: Bridget Meyer
- CSM Team
- Lead: Gary Sullivan
- Staff/SMEs: Jeff Uehling

## Janus/CRIX CDR Vision

**Potential Extensions**:
- 1571/1572 form data, CDUS/CTMS, AdAM, SAEs, etc.

**Janus data extensions**

- Data Load API

**FDA Submissions Source**

- caBIO/BRIDG/HL7 RIM

- JDBC 2

**Analysis and Reporting Applications**

- Analytical and Reporting Applications (SAS, WebSDM, ToxViewer, I-Review, etc.)

- Query Application

- BIOGopher (Excel with caBIO Driver)

- caDSR

- EVS

- C
- S
- M

- ODM and SDTM
- Define.XML
- (HL7 eDCI)

- caGRID

- caBIG

- Janus/CRIX Clinical Data Repository

- Study Specific
- Data Marts

## Janus/CRIX CDR Vision

**Potential Extensions**:
- 1571/1572 form data, CDUS/CTMS, AdAM, SAEs, etc.

**Janus data extensions**

- Data Load API

**FDA Submissions Source**

- caBIO/BRIDG/HL7 RIM

- JDBC 2

**Analysis and Reporting Applications**

- Analytical and Reporting Applications (SAS, WebSDM, ToxViewer, I-Review, etc.)

- Query Application

- BIOGopher (Excel with caBIO Driver)

- caDSR

- EVS

- C
- S
- M

- ODM and SDTM
- Define.XML
- (HL7 eDCI)

- caGRID

- caBIG

- Janus/CRIX Clinical Data Repository

- Study Specific
- Data Marts

**Team 2**

**Team 3**

**Team 3**

**Team 4**

**Team 1**

## Project Plan Overview

## Janus/CRIX User Requirements

- Kathleen Martin/Elise Blaese

## JANUS/CRIX User Requirements

**Scope of Responsibilities – Phase Ia:**
- Understand how Janus data warehouse users will access NDA submissions data, based on roles. IBM will compose 10 use cases.
- Develop user requirements workshop/interview guides
- Conduct workshops/interviews with FDA and NCI/caBIG staff to confirm our current understanding of the intended usage.
- Develop use cases for accessing data in the Janus data warehouse.

## JANUS/CRIX User Requirements

- Project Plan – Phase 1a
- Develop Interview Guides (input from technical team members and NCI)
- Conduct requirements interviews/workshops and develop usage test cases. Plans to date include:
- CRIX Exec Committee - conducting 3 parallel workshops: Design, Business, and Functional Requirements (June 30, DC)
- FDA audience (July 14, Rockville)
- Internal NIH/NCI audience (July 6 and July 8)
- Cancer Centers (July 29, Chicago)
- Conduct post-interview debriefs and follow up
- Develop Requirements Analysis

## JANUS/CRIX User Requirements

**Deliverables:**
- Workshop/interview guides
- Workshop output/interview summaries
- User requirements analysis
- Use test cases

## JANUS/CRIX User Requirements

**Identify User Roles:**
- FDA Roles:
- Medical Officers
- Pharmacologist
- Biostatistician
- Data Administrator
- etc.
- NCI/Cancer Center Roles:
- Principle Investigator/Investigator
- Study Coordinator
- Data Manager
- Biostatistician
- etc.

## JANUS/CRIX User Requirements

**User Interviews / Workshops Overview**
- Project background
- Interview / Workshop subject areas:
- Roles within categories (researchers, clinicians, reviewers, and data management)
- Types of data accessed
- Raw and summary data
- Within studies/across studies,
- Queries, reports, etc.
- Volume of users
- Current tools used and features/functionality/purpose
- Data metrics for large, medium, and small studies (role-specific)

## Dependencies
Confirmation of roles and finalize interview guide
Availability of interviewees and workshop attendees
Identification of additional roles
Identifying/providing reference material or background information

- Confirmation of roles and finalize interview guide
- Availability of interviewees and workshop attendees
- Identification of additional roles
- Identifying/providing reference material or background information

**JANUS/CRIX User Requirements**

## Data Access

- Joel Dubbels
- Bridget Meyer

## Data Access Overview (development primarily Phase 1B timeframe)

**Scope definition**
- Develop Java program APIs enabling application access to Janus database (a subset of the overall model)
- APIs will be developed using NCI’s caCORE Toolkit V3
- Development to caBIG “silver level compatibility” guidelines

## Janus/CRIX CDR Vision

**Potential Extensions**:
- 1571/1572 form data, CDUS/CTMS, AdAM, SAEs, etc.

**Janus data extensions**

- Data Load API

**FDA Submissions Source**

**Analysis and Reporting Applications**

- Analytical and Reporting Applications (SAS, WebSDM, ToxViewer, I-Review, etc.)

- Query Application

- BIOGopher (Excel with caBIO Driver)

- C
- S
- M

- ODM and SDTM
- Define.XML
- (HL7 eDCI)

- caGRID

- caBIG

- Janus/CRIX Clinical Data Repository

- Study Specific
- Data Marts

- caDSR

- EVS

- Understand/map to existing NCI EVS and CDE services as appropriate

- Validate caCORE toolkit functionality / compatibility

- caBIO/BRIDG/HL7 RIM

- JDBC 2

## Data Access Overview (Phase 1B timeframe)

**Dependencies**
- Development of use case for each user role
- Definition of Janus/CRIX model subsets
- Definition of data access requirements over the data subsets
- Technical assistance from NCI for EVS and CDE work
- Need NCI contact person to help resolve functional issues encountered
- Need NCI assistance with running semantic connector to establish appropriate correlation to existing caCORE EVS and CDE

## Data Access Overview (Phase 1B timeframe)

**Key milestones**
- Successful db access using one object built via IBM UML modeling tool and caCORE Toolkit
- Fully defined logical model (UML) over the agreed-to subset of the Janus/CRIX model
- Successful processing of UML model through caCORE semantic connector
- Successful code generation from UML model via caCORE toolkit build process
- Successful data access via caCORE interface

## Doug Del Prete

**Janus/CRIX****Data Load and Warehouse**

## JANUS/CRIX Data Load and Warehouse

**Scope:**
- Given specific study data and set of domains
- Load the data from the identified study/domains into the JANUS/CRIX data warehouse,
- Encrypt and support the identified data access under the defined CSM user access controls

## Janus/CRIX CDR Vision

**Potential Extensions**:
- 1571/1572 form data, CDUS/CTMS, AdAM, SAEs, etc.

**FDA Submissions Source**

**Analysis and Reporting Applications**

- Analytical and Reporting Applications (SAS, WebSDM, ToxViewer, I-Review, etc.)

- Query Application

- BIOGopher (Excel with caBIO Driver)

- C
- S
- M

- ODM and SDTM
- Define.XML
- (HL7 eDCI)

- caGRID

- caBIG

- Study Specific
- Data Marts

- caBIO/BRIDG/HL7 RIM

- JDBC 2

- caDSR

- EVS

- Source data
- Study/Domains
- Data transport format
-      (XML preferred)
- define.xml to populate Codelists

## JANUS/CRIX Data Load and Warehouse

**Plan:**
- Phase 1A:
- Build a prototype system including JANUS data model and sample data (with encryption)
- Phase 1A/B: Deliver System to NCI
- Get identified study/domain data from NCI
- Develop and deliver Janus/SDTM V1.0 or V1.1 education
- Assist NCI to map their clinical trial data to SDTM (based on the final outcome from Phase 1A)

## JANUS/CRIX Data Load and Warehouse

**Plan (continued):**
- Phase 1B** **
- Develop final Janus-SDTM data element mapping
- Load initial data set
- Verify all data loaded correctly (joint with NCI)
- Encrypt selected portions of the data warehouse
- NCI to test with JANUS data warehouse and related access tools
- Implement user access control

## JANUS/CRIX Data Load and Warehouse

**Plan (continued):**
- Phase 1C
- Adjust the Janus Data Warehouse based on NCI feedback
- Load final data set and encrypt
- Exercise test plans to verify correct data load
- Conduct basic load testing (as possible)
- Develop recommendations for production system
- Other data formats and sources
- System configuration and sizing
- Final Report

## JANUS/CRIX Data Load and Warehouse

**Dependencies**
- Study/domain data
- Consultation from NCI on the data mappings and data encryption
- NCI to evaluate pilot implementation and provide feedback for Phase 1C

## CSM Overview

- Garry Sullivan

## Janus/CRIX CDR Vision

**Potential Extensions**:
- 1571/1572 form data, CDUS/CTMS, AdAM, SAEs, etc.

**FDA Submissions Source**

**Analysis and Reporting Applications**

- Analytical and Reporting Applications (SAS, WebSDM, ToxViewer, I-Review, etc.)

- Query Application

- BIOGopher (Excel with caBIO Driver)

- ODM and SDTM
- Define.XML
- (HL7 eDCI)

- caGRID

- caBIG

- Study Specific
- Data Marts

- caBIO/BRIDG/HL7 RIM

- JDBC 2

- caDSR

- EVS

- C
- S
- M

## Common Security Module Overview (Phase 1B timeframe)

**Scope**
- Application Authentication will be done through AuthenticationManager.  (Choices RDBMS or LDAP)
- Authorization checks will be provided through the AuthorizationManager run-time methods.

## Common Security Module Overview

**Customer dependencies**
- Definition of roles and data access requirements over the subset Janus/CRIX model for each user type
- Subset Janus/CRIX model populated with test data
- Development of a logical use case scenario for each user type
- Implementation of use case scenarios

## Common Security Module Overview

**Key milestones:**
- Install and configure CSM
- Application sign-in and authentication
- Successful data access for each user role per assigned authority
- Reject unauthorized data access

## For use by NCI and IBM team, FDA, and other interested parties . . . 

- Being used for initial project tracking, exchange of reference materials and discussion, meeting info, project calendar, etc.
***All artifacts will migrate to caBIG CVS repository as they are completed**

## Secure login based on IBM registered ID*

*** All artifacts will migrate to the caBIG CVS repository as they are completed**

## Recap

- Discuss issues/concerns
- Document meeting action items
- Answer questions

- Questions ??