# Presentation: 496670

## Reporting and SharingSpecial Interest Group

***Christo Andonyadis, D.Sc***
***Associate Director, Clinical Trials Application Engineering***
***NCI Center for Biomedical Informatics and Information Technology***
***andonyac@mail.nih.gov***

***caBIGTM Clinical Trials Management Systems Workspace Face-to-Face Meeting***
***May 30 – 31, 2007***
***Portland, Oregon***

## Agenda

**Overview of Reporting/Sharing SIG Activities**
**Scope, Validation and Feedback**
**Adverse Event Reporting and Collection (caAERS)**
**Routine Data Exchange (RDX)**
**Clinical Trials Database (CTDB)**
**Clinical Trials Object Model (CTOM)**
**Janus (FDA Repository)**
**Requirements Gathering for Data Sharing (after the break)**

## What is the Clinical Trials Management Systems Workspace Trying to Achieve?

**Facilitate the **_**planning**_** and instantiation of clinical trials, (and their **_**monitoring**_** of trials once they are instantiated)**
**Facilitate the **_**conduct **_**of clinical trials**
**Facilitate the **_**reporting and sharing**_** of clinical trial data to existing/new destinations, **
**Achieve **_**interoperability**_
- Increase the ability of systems to *access *and* use* the data and functionality of other systems
- Facilitate the integration of new sources and destinations of data

## Special Interest Groups and Projects

**Interoperability**** **
**System Interoperability and Harmonization**
**Structured Protocol Representation (BRIDG)**
**Clinical Trials Interoperability Project**

**Planning/**
**Monitoring**** **
**Investigator and Site Credential Repository**
**Study Initiation Tool**
**Protocol Lifecycle Tracking **
**FIREBIRD**
**DCP/DESK**

**Conduct**
**Standardized Case Report Forms**
**Cancer Central Clinical Database (C3D)**
**Participant Registry **
**Laboratory Interface**
**Financial/Billing**
**Study Calendar**
**Subject Prescreening**
**Vendor Systems**

**Reporting/**
**Sharing**** **
**Clinical Trials Database**
**Routine Data Exchange**
**Clinical Trials Object Model (CTOM)**
**Janus (FDA Repository)**
**Adverse Event Reporting and Collection**
**Clinical Data System (CDS/CDUS)**

## Clinical Trials Database (CTDB)

| URL: | https://cabig.nci.nih.gov/workspaces/CTMS/CTWG_Implementation/clinicaltrialsdatabasesig |
| --- | --- |
| Status: | Clinical Trials Working Group (CTWG) Informatics Initiative |
| Summary: | The initiative will establish a comprehensive community accessible database that will contain information on all NCI-supported clinical trials with the ultimate goal of enhancing cancer trial management and planning through improved coordination and cooperation across the many institutions involved in cancer trials. An electronic database containing complete, up-to-date information (e.g., status, protocol, accrual, adverse events, toxicity, efficacy) of all cancer clinical trials will be of benefit to all members of the clinical trials community, including patients. The consolidated availability and routine review of data reported from all NCI-funded clinical trials is essential to the timely recognition and appropriate dissemination of emerging insights on the safety and efficacy of new treatments. |

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Routine Data Exchange (RDX)

| URL: | https://cabig.nci.nih.gov/workspaces/CTMS/routine-data-exchange-sig/ |
| --- | --- |
| Status: | Pilot SIG |
| Summary: | Define the requirements for a regulatory reporting interface module that will facilitate the submission of clinical trial reports (e.g., Summary 3 and Summary 4) electronically to NCI’s CDS (Clinical Data Update System) and the NCI’s Clinical Trial Monitoring Service (CTMS). This application will capture relevant data from multiple systems and in multiple formats and translate them into the required formats. The process will be automated to improve workflow and minimize manual operations. Additionally, this module will allow retention of data that is lost under current reporting mechanisms to facilitate internal analysis of ongoing studies.
 |

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Clinical Trials Object Model (CTOM)

| URL: | http://gforge.nci.nih.gov/projects/ctom/ |
| --- | --- |
| Status: | Under development |
| Summary: | CTOM is a UML reference implementation of the BRIDG model, i.e., a UML model of the clinical trials domain. The classes identified in CTOM are intended to be instantiations of the abstract BRIDG classes. 

CTOM will enable data from any Clinical Trials Data Management System (CDMS) or data source to be available to the cancer research community through Java APIs, and thus will be a means to enable the broad sharing of clinical trials data from multiple sources in such a way that data from different sources are compatible.

The initial test load of CTOM was taken from the CTMS (Theradex) system. |

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Janus (FDA Repository)

| URL: | http://crix.nci.nih.gov/projects/janus/ |
| --- | --- |
| Status: | Under development |
| Summary: | Janus is a standards-based clinical data repository that utilizes an open source data model originally created by the Food and Drug Administration in partnership with IBM.

The Janus repository provides a data collection and analysis warehouse for clinical trial data submitted for protocols (what was supposed to happen) as well as clinical outcomes data (what did happen - events, interventions, etc.).

All of this information is submitted in Investigational New Drug (IND) applications to the FDA. Depending on the particular trial, the holder of the IND may be NCI, a pharmaceutical or biotechnology company, an NCI Cooperative Group or an academic institution funded by NCI. |

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Adverse Event Reporting and Collection (caAERS)

| URL: | https://cabig.nci.nih.gov/tools/caAERS |
| --- | --- |
| Status: | Release 2 currently under development |
| Summary: | A comprehensive set of open source tools centered around the collection, processing and reporting of information related to adverse events that occur during the course of a cancer clinical trial.  Specific functionalities include:
 Capture of AEs and Notification Alerts
 Interface to Local Clinical Trial Databases
 Mapping to Vocabularies and Coding Systems
 Report Generation and Submission to External Agencies |

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Clinical Data System (CDS/CDUS)

| URL: | https://cdsweb.nci.nih.gov/cdsweb |
| --- | --- |
| Status: | Web in production
Protocol Abstract & Analysis/Reporting piloted |
| Summary: | CDS Web is fully in production allowing web submitters to enter their CDS data for submission to CTEP

The Protocol Abstraction module has been piloted to allow users to enter non-CTEP protocols for CDS (Complete or Abbreviated) reporting

The Analysis/Reporting module has been piloted to allow users to run reports on CDS data |

## Clinical Data Flow - TODAY

- SDTM
- Domain Model

- CTMS
- CTEP/Theradex
- Submission Standard

- CDS Web

**Today**

- JReview

- SDTM Viewer (IBM)

**Clinical Data Flow - TODAY**

## Tomorrow

- SDTM
- Domain Model

- CTMS
- CTEP/Theradex
- Submission Standard

- CDS Web

**Tomorrow**

- JReview

- SDTM Viewer (IBM)

- CTOM
- Object Model APIs

- CTOM Viewer

**Clinical Data Flow - TOMORROW**

## Future

- SDTM
- Domain Model

- CTMS
- CTEP/Theradex
- Submission Standard

- CDS Web

**Future**

- JReview

- SDTM Viewer (IBM)

- CTOM
- Object Model APIs

- CTOM Viewer

- CDS
- Object Model APIs

**Clinical Data Flow - FUTURE**

## Requirements Gathering for Clinical Trial Data Sharing

**Data Sharing in the Reporting/Sharing SIG**
**Data Sharing Opportunities and Potential Obstacles, other DSIC Considerations**
**Adverse Event Reporting and Collection (caAERS)**
**Clinical Data System (CDS/CDUS)**
**Routine Data Exchange (RDX)**
**Clinical Trials Database (CTDB)**
**Clinical Trials Object Model (CTOM)**
**Janus (FDA Repository)**

## Adverse Event Reporting and Collection (caAERS)

| Data stored: | Adverse event specific data for a defined subject on a defined study. Based on information provided, the system captures the severity of the adverse event and provides some workflow for identifying and capturing decisions necessary for further reporting. |
| --- | --- |
| Shared / usefully shareable data: | Adverse event data. |
| Access Controls: | caAERS utilizes the NCI Common Security Model (CSM) for security.  caAERS must be able to authenticate both local users and external users.  Since the domain objects are common to all tiers, the approach taken in caAERS is to express authorization policy strictly in terms of the domain objects and the actions that can be performed on them. 
 |

**Adverse Event Reporting and Collection (caAERS)**

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Clinical Data System (CDS/CDUS)

| Data stored: | Adverse event specific data for a defined subject on a defined study. Based on information provided, the system captures the severity of the adverse event and provides some workflow for identifying and capturing decisions necessary for further reporting. |
| --- | --- |
| Shared / usefully shareable data: | Protocol administrative data
Patient administrative, demographic and outcome data |
| Access Controls: | caAERS utilizes the NCI Common Security Model (CSM) for security.  caAERS must be able to authenticate both local users and external users.  Since the domain objects are common to all tiers, the approach taken in caAERS is to express authorization policy strictly in terms of the domain objects and the actions that can be performed on them. 
 |

## Routine Data Exchange (RDX)

| Data stored: | RDX is not an application, just an activity to codify NCI reporting requirements.  Data are defined by NCI and will probably surface as part of the Clinical Trials Database (CTDB). |
| --- | --- |
| Shared / usefully shareable data: | Again, see CTDB. |
| Access Controls: | Again, see CTDB. |

**Routine Data Exchange (RDX)**

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Clinical Trials Database (CTDB)

| Data stored: | All clinical trials data, both aggregate and raw, required by any kinds of site-NCI reporting, including NCI sponsor reporting, Cancer Center Summary 4, etc. |
| --- | --- |
| Shared / usefully shareable data: | All of the above. |
| Access Controls: | To be defined by this SIG. |

**Clinical Trials Database (CTDB)**

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Clinical Trials Object Model (CTOM)

| Data stored: | All clinical trials data (note that CTOM may be instantiated as a database or merely a set or APIs). |
| --- | --- |
| Shared / usefully shareable data: | All clinical trials data, usually data from other systems represented by CTOM. |
| Access Controls: | CTOM access controls should be flexible; requirements will be determined by the source and destination systems. |

**Clinical Trials Object Model (CTOM)**

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Janus (FDA Repository)

| Data stored: | All clinical trials data submitted to FDA for regulatory approval. |
| --- | --- |
| Shared / usefully shareable data: | All of the above; note, however, that much of the data will be proprietary. |
| Access Controls: | CSM will be used.  Assume only FDA will have access to all data; other groups only to data that they themselves submitted. |

**Janus (FDA Repository)**

**Notes:**
Currently, Version 1.1 is available for adoption.  Early adopters include: 
University of California – Irvine
Georgetown University - Lombardi Comprehensive Cancer Center

## Privacy/Intellectual Capital Terms & Conditions Decision Tree – DSIC WS

## Requirements Gathering for Clinical Trial Data Sharing

|  | Adverse Event Reporting and Collection (caAERS) | Clinical Data System (CDS) | Routine Data Exchange (RDX) | Clinical Trials Database (CTDB) | Clinical Trials Object Model (CTOM) | Janus (FDA Repository) |
| --- | --- | --- | --- | --- | --- | --- |
| IP Value (need for protection) |  |  |  |  |  |  |
| Data Sensitivity (Regulatory Status) |  |  |  |  |  |  |
| IRB or Intellectual Restrictions (Policy or Consent Limitations)  |  |  |  |  |  |  |
| Sponsor Restrictions (Contract Terms & Conditions |  |  |  |  |  |  |

## Next Steps

**Summary of discussion points**
**Review of Action Items**

## Thank you!