# Presentation: 280177

## Study Conduct SIG Breakout Report Out

***George Komatsoulis,**** ****Ph.D., NCI Center for Biomedical Informatics and Information Technology***
***Rachel Nosowsky, J.D., University of Michigan***

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

## Executive Summary

**George Komatsoulis led the session in reviewing the scope of project and activities within the Study Conduct SIG**
- caMatch (Prescreening), Cancer Central Clinical Patient Registry (C3PR), Cancer Central Clinical Database (C3D), Vendor Systems, caXchange, Patient Study Calendar, Financial/Billing, and Library of Standard Case Report Forms (CRFs)
- The presentation for the Study Conduct SIG Breakout is available at: _[https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/Face_to_Face/2007_May_F2F/SIG_Breakout_Study_Conduct.ppt](https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/Face_to_Face/2007_May_F2F/SIG_Breakout_Study_Conduct.ppt)__ _
**Among the projects and activities discussed, a high level of sensitivity was found concerning the sharing of Protected Health Information (PHI) with dependencies on sponsorship and intended data usage.**** **
**Session participants agreed that it will be important to collect information using CTMS tools and to produce derivative datasets that can be pushed out to a broader set of users.**
**Group discussion on the data sharing policies and issues applicable to these projects and activities are outlined in the following slides.**

## Study Conduct SIG Breakout Output

|   | Standardized Case Report Forms | Clinical Trials Databases (including C3D) | Participant Registry (C3PR) | Laboratory Interface (caXchange) | Financial/Billing | Study Calendar (PSC) | Subject Pre-screening | Vendor Systems |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| IP Value (Need for Protection) | - Study-specific CRF/Research use Questionnaire

- Some CRF subject to copyright
- Migration to open structure from proprietary standard?
- Copyright data access and attributes
- May have IP value (especially validated questions)
- Dependent on access -- negotiate on reasonable/non-discriminatory terms(LOW) | - Trial sponsors have IP - Economic/ Risk Value - Risk if released(HIGH) | - Accrual Information- Participants (?)(LOW) | - Patrick McConnell had questions about trial design revealed(LOW) | - Risks to revealing economic Exposing of rate basis --> risk(MED to HIGH) | - Trial structure- Strategies and design can be proprietary- Competitors want to pre-empt on-going trials in competitive drugs(LOW to HIGH) | - All you need is eligibility criteria- If they are using the application actively, publicly recruiting patients(LOW - mostly) | See Clinical Trials Applications |

## Study Conduct SIG Breakout Output

|   | Standardized Case Report Forms | Clinical Trials Databases (including C3D) | Participant Registry (C3PR) | Laboratory Interface (caXchange) | Financial/Billing | Study Calendar (PSC) | Subject Pre-screening | Vendor Systems |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Data Sensitivity (Regulatory Status) | (LOW) | - PHIHIPAA & Regulatory(HIGH) | - PHI/Names with info for participants(HIGH) | - PHI (MRN + Name, Trial ID)(HIGH) | (LOW) | - PHI (treatment etc. on patient calendar)(HIGH) | - All data is published in current version- Not necessary some be kept as cookies locally for example- Persistence tier, even at the behest of person adding(HIGH) | See Clinical Trials Applications |
| IRB Institutional Restrictions (Policy Consent Limitations) | - IRB restrictions on asking certain types of questions = may limit what can go in the library(LOW)
 | - Varies by institution and by trial- Jack London had questions | (Blank) | (Blank) | (LOW) | (Blank) | (Blank) | See Clinical Trials Applications |

## Study Conduct SIG Breakout Output

|   | Standardized Case Report Forms | Clinical Trials Databases (including C3D) | Participant Registry (C3PR) | Laboratory Interface (caXchange) | Financial/Billing | Study Calendar (PSC) | Subject Pre-screening | Vendor Systems |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sponsor Restrictions (Contract Terms & Conditions) | - History of some difficulty although largely resolved for NCI-sponsored trials- Good responses thus far from industry sponsors- CDASH broadly focused beyond oncology, leading to less oncology focus for industry forms(LOW) | - The NCI as sponsor, barriers to sharing = low- Other institutions/3rd party sponsors may have issues- Sponsor-by-sponsor basis(LOW to HIGH) | (Blank) | (Blank) | - Some sponsor concerns, work costs(MED to HIGH) | (Blank) | (Blank) | See Clinical Trials Applications |

## Issues

**There is a need for identifying other mechanisms for sharing data (in a de-identified data set, etc.) to allow data sharing to go forward.**
**How much PHI is needed to do something useful?**
**Can we define a linked data set that we can easily start to share out?**
**Data sharing sensitivity specifics depend on the system/ capabilities.**
**In order for caBIGTM to proceed, we must consider the basic architectural guidelines for data sharing.**
**There are questions around what type of information is being retained and where.**
**Should we identify the shareability of individual data elements in our standard data models (such as CTOM) to facilitate sharing of those portions of the data which can be shared?**