ECOG ITrack Initiative Integrated Trial Development Process

eastern cooperative oncology group

ECOG ITrack Initiative

Integrated Trial Development Process

March 23, 2010Donna Marinucci


OEWG Vision

Based on OEWG’s Ultimate Vision:

Coordinated, collaborative, interactive processes for timely development, review, revision and approval of all NCI-supported clinical trials.

-- OEWG Clinical Trials Advisory Committee Report (11-4-09)


Considerations for Process Improvement

Trial development steps performed in parallel

Project management/protocol tracking tools

Establish comprehensive, reliable system for reporting timeline performance for each step in trial activation

Assessment of staffing needs, job responsibilities, or reassignment

Collect timeline performance data


ECOG Challenges

Multiple components from concept to protocol activation

Increased complexity of protocol development

No (real-time) central communication tool to share information among a wide variety of stakeholders

How to utilize current systems and track individual components; but w/o having to enter data in multiple locations

No document management system

Cost and rapidity of implementation


Integrated Protocol Tracking System

Reinforces Importance of Parallel Tracks

Systematically Developed Timelines

Highlights Impact of Delays

Variance Reporting ; Actual vs Projected

timelines

ITrack Project Requirements Planning


In Addition to Tracking Timelines

Provides Centralized Document Storage

Version Control

Archiving

Discussion Thread

Reporting

Audit Trail

ITrack Document Management


ITrack System Specifications

Project Tracking System

Microsoft Project

Uses Windows SharePoint Services

20 users license $2850.00

Document Management System

Knowledge Tree

20 users license $1957.65

MySQL for the database, Apache for the web server

Custom Coding/Integration - 240 development hours


Access by authorized ECOG staffAbility to limit a user’s access only to content

that the user has been authorized to view.Document storage, change tracking, audit trail

and audit reportingTrack and assign user tasks and alert users of

tasksSend email notification of changes, issues and

or alertsDiscussion area for questions comments

concerning the project , task or issues

System and Process


Protocol Development Laboratory Correlatives Industry Support Legal & Contracting Forms Development

Regulatory Issues

Major Project Areas


ITrack Project Server Home Page


Each approved concept is entered on the project plan with standardized timeframes and resources.


Worksheet to Statistician Forms Team All Internal Reviews NCI Reviews through NCI’s CDE Approval of CRF Packet Input from Industry, If Needed

Case Report Forms


♦ Industry Checklists♦ Kick-off Meeting with Industry ♦ Industry Budget Review/Approval♦ Negotiation of Industry Agreement♦ Additional Agreements, If Required

Industry/Contracts


Agreements with Industry Budgets for Industry Concepts Correspondence Forms Industry Checklists Protocols Timelines

ITrack Documentation


Regulatory

Documentation Received by Regulatory Officer

IND Application Submitted to FDA FDA Reviews through Approval of IND Application Letter of Cross-Reference from

Industry, As Needed

Regulatory


Ability to Run Queries

Actual vs Projected Dates

Analyze Trends

Barriers to Activation

Systematic Identification of at Risk

Protocols

ITrack Reporting


Organized by Protocol Accessibility Within ECOG Documents Version Controlled Permanent Record of Documentation Reporting Capabilities Resource for Future Studies

ITrack Documentation


Upon user log-in, the Home Page (dashboard) displays any/all of the following:♦ Items that require attention

♦ Alert/notification emails for these items are sent to designated external email addresses

♦ Checked-out Documents♦ Go To Document ID♦ Recently Added/Changed Documents


Each concept /protocol has a folder for storage and communication of all relevant information. Only authorized users can view information in the protocol folder.


Concept/protocol folders contain the above folder structure for supporting documentation. Only authorized users can view information in the protocol subfolders.


Information pertaining to

document details and all changes are captured and

displayed


Discussion threads surrounding the protocol can be created and replies posted. Discussion threads can be closed when the discussion has come to a conclusion.


An audit trail is available at the folder and document levels via the transaction history


Questions and Discussions

Questions, Comments, Suggestions

Next Steps

ECOG ITrack Initiative Integrated Trial Development Process

Documents

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