ACRIN Presentation
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ACRIN Presentation
• A service of the National Cancer Institute (NCI) created to:
– Increase enrollments to NCI funded trials by providing investigators with access to trials outside their Group or Network membership.
• North America, Canada, International trials / sites
– Reduce the administrative burden on the
Cooperative Groups, CTEP-funded Phase 2
Contractors and other NCI funded contractors for collection of regulatory data, and other administrative, and data management work.
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ACRIN Presentation
• Background
– Product of Armitage Committee recommendations
– The original Cancer Trials Support Unit contract was awarded in 1999
– Managed by NCI Cancer Therapy & Evaluation
Program (CTEP)
• Current (2 nd ) contract began September 1, 2006
– Significant changes in scope of work
– Influenced by CTWG recommendations
– Contracting Team
• Westat, Rockville, MD (prime)
• Coalition of Cancer Cooperative Groups ,
Philadelphia, PA (subcontractor)
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ACRIN Presentation
NCCTG
North Central
Cancer Treatment
Group
NCIC-CTG
National Cancer
Institute of Canada
Clinical Trials Group
NSABP
National Surgical
Adjuvant Breast and Bowel Project
SWOG
Southwest
Oncology Group
ECOG
Eastern Cooperative
Oncology Group
GOG
Gynecologic
Oncology Group
CALGB
Cancer and Leukemia
Group B
RTOG
Radiation Therapy
Oncology Group
ACOSOG
American College of Surgeons
Oncology Group
COG
Children’s Oncology
Group
IBCSG
International Breast Cancer
Study Group
21 Sept. 2011 ACRIN Presentation
Other NCI Funded
Research…
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• Basic Non-menu
– Regulatory Support Services
– Financial Services
– OPEN
– CDMS Support Center
– IT Development
• Basic Menu
– Customer Service
– Audit and Data Quality
– Protocol Implementation Services
– Promotion and Educational Services
– CTSU Web Site
• Comprehensive Support Services
– Clinical Data Management Services
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ACRIN Presentation
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ACRIN Presentation
• Initial services that ACRIN will utilize:
– Institution and Person Roster Support
• CTEP-IAM and IR registrations
• Single Sign-on integration
– Regulatory Data Collection and Support
– Rave Integration Support
– Help Desk Support
– Promotion, Education and Training
– Information Dissemination (e.g. Web Sites,
Newsletters)
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ACRIN Presentation
• Public and password protected areas of CTSU web site
• Contains all documents required to conduct a protocol within the CTSU
• Includes information to monitor rosters and regulatory submissions
• Information provided for general public, health care professionals, and CTSU members
• Contains links to other CTSU applications
• Used for emergency and urgent communications to all clinical trials participants
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ACRIN Presentation
CTEP-IAM
Fact Sheet
CTEP-IAM Link
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ACRIN Presentation
• A CTEP IAM Account is required to access CTSU resources.
– Member Web Site (https://members.ctsu.org)
– OPEN
– Rave
• Provides consistent identification of personnel across all participating organizations.
• Annual registration required via CTEP-IAM
• Password update every 60 days per NIH Policy
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ACRIN Presentation
• Register online: https://www.ctsu.org
• Click on the links entitled:
– “Register with the CTSU”
– “CTEP-IAM registration system”
– “Request New Account”
• Complete the appropriate registration
– Physician (IR) or Associate (CTEP-IAM)
– IAM is recommended for physicians but not required
• Await e-mail to confirm user name and password
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ACRIN Presentation
• From the Regulatory Tab
– View all institution rosters associated with the user
– View person information including contact and registration and roster status
– View the ACRIN institution and person rosters
– View investigator’s CTEP status
– Assign site roles on the CTSU roster
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ACRIN Presentation
Institution and Person roster associated with user
Person summary
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ACRIN Presentation
Can view persons by roster
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On the CTSU roster persons with the
Site DA and AD roles can assign additional roles
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ACRIN Presentation
• The CTSU Regulatory Office is located at the Coalition of
Cancer Cooperative Groups office in Philadelphia, PA. All regulatory documents are sent to this office.
• The CTSU Regulatory Office collects regulatory information for
ALL treatment and prevention (Phase I, II, & III) trials for CTEP sponsored Cooperative Group Trials.
• Group and Network Operations’ offices can view ALL regulatory information for each of their sites.
• Establish and communicate policies and procedures related to regulatory issues.
• Provide Help Desk services.
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ACRIN Presentation
• Regulatory Data is maintained in the Regulatory Support
System (RSS)
– Oracle-based system
– Interacts with CTEP and Cooperative Group through
Real-time Data Transfer System (RDTS) or web services
– Integrates with enrollment system (OPEN), financial system, and data management systems (Rave)
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ACRIN Presentation
• Cover Sheet (i.e. CTSU Transmittal Sheet)
• One of the following (or combination):
– IRB approval (i.e. CTSU IRB Certification Form)
– IRB approval letter or
– Protection of Human Subjects Assurance
Identification/IRB Certification/ Declaration of Exemption form)
• IRB-approved consent forms
– Only when required by the lead Group
• Protocol-specific regulatory documents
– As stated in each protocol (e.g., protocol-specific 1572)
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ACRIN Presentation
Checking Protocol Specific Requirements

ACRIN Presentation
• Allow 3 business days for regulatory documents to be processed in RSS before checking status on CTSU web site
• Sites should contact CTSU Regulatory Help Desk if a patient enrollment is imminent
• The status can be checked on the Member’s web site
( http://members.ctsu.org/ ) under the Regulatory tab.
• The user can look up RSS Site Registration Status or RSS
Site IRB Expiration Status
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ACRIN Presentation
• All initial approvals
• All continuing reviews
• All amendments, as indicated by the Lead
Group or Network
• Principal Investigator Changes
• Protocol-Specific Requirements as outlined by the protocol
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ACRIN Presentation
Enter Site Code
User can filter for status
Registration status
& missing requirements are listed
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Link will provide detailed protocol requirements list
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ACRIN Presentation
Requirements list, site status per requirement
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Approval expiration notice and expired approvals
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ACRIN Presentation
• Wide variety of educational materials and resources
– CTSU Operations Information
• Newsletters
• Policies and guidance documents
• Process documents
– Protocol-Specific Materials
• Protocol specific schemas, protocol cards, Physician Fact
Sheets
– Audit Resources
• Audit presentations
• Protocol-specific audit worksheets
– Researcher Resources
• Links to CTEP and other resources
– Educational Presentations and Webcasts
• CTSU educational materials
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ACRIN Presentation
Process
Flow sheets
Protocol-specific materials
Audit worksheets
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ACRIN Presentation
• Track progress of concepts and protocols through the development process
• Write CTSU logistical appendix to be used with each protocol on the menu
• Coordinate implementation within the CTSU
• Prepare documents for posting on the CTSU web site
• Review all amendments for impact on CTSU support services
• Develop CTSU Bi-Monthly Broadcasts
• Work with each Group’s protocol development organization and with the NCI/CTEP Protocol
Information Office
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ACRIN Presentation
• View protocols by multiple categories
– By Site
– Lead Organization
– Cancer Type
– Study Type
– Phase II
– Limited Access or Special Programs
• View protocol reports, CTSU Newsletters, and Bimonthly Broadcasts
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My
Favorites
ACRIN Presentation
Access to Broadcast,
Newsletters, protocol updates and reports.
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ACRIN Presentation
• Use single system for patient enrollments to all Cooperative
Group Trials.
• Utilizes existing CTSU protocol and regulatory data for validation and credentialing.
• Users maintain a single password - standard CTEP-IAM.
• Available 24/7 from the OPEN web site.
• View all OPEN enrollments across all Groups.
• Seamless integration with existing Group registration and randomization systems.
• Training materials available under the OPEN tab
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ACRIN Presentation
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ACRIN Presentation
• Provides Comprehensive Data Management Service
– For select studies (e.x. TailorX)
– Case Report Form development
– Database development
– Data management services
– Support electronic data transfer
– CDUS reporting
• Integral in coordination of Rave CDMS Support
Center (CSC)
– Working group coordination and trainings
– Development support
• Coordinates CTSU implementation of Rave
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ACRIN Presentation
• Provides site users continuous access to a variety of clinical data related information.
– Patient Accrual data
– Received Forms (CRFs)
– Delinquent CRFs (pending release)
– Outstanding Data Clarification Forms (DCFs)
– Remote Data Capture (RDC) Discrepancies
• Limited to studies where CTSU acts as the data management center.
• Accrual information available for all CTSU menu studies
• Access to RDC links
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ACRIN Presentation
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ACRIN Presentation
• Enterprise Oracle database supporting Regulatory Support
System, Real-time Data Transfer System, Financial
Management System, Clinical Data Transfer System, and
CTSU Web site
– Available on secure Web servers
– Used by staff at Westat, Philadelphia, and at
Cooperative Group offices around the country
– Live link to NCI-CTEP enterprise database
• Oracle Clinical and Medidata Rave for data management
– Including OC Remote Data Capture (RDC) system
• Applications development using Oracle Designer
• Support for clinical data systems and web technology
• Failover and capabilities for contingency operations
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ACRIN Presentation
• Negotiate contracts and budgets with Cooperative Groups and clinical sites for support of protocol development, fiscal agent activities, and site operations
• Provide reimbursements for activities against negotiated budgets and for travel expenses
• Reimburse sites for enrollment of patients to treatment trials
• Provide payments for complexity trials
• Prepare financial reports to NCI
• Work with Group administrative personnel, subcontractors, and NCI Contracts Management Branch
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ACRIN Presentation
• Help Desk Support
– Provide services from 9:00 am to 5:30 pm ET.
– Develop answers and response scripts to frequently asked questions (FAQs)
– Work with CTSU operational teams to be prepared and informed of new initiatives and communications needs
• Registrars
– Serve as registration point for all non-lead group enrollments to CTSU menu trials not processed in OPEN.
– Receive all patient enrollment paperwork from sites and register patients via Group-specific registration systems.
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ACRIN Presentation
• CTSU Help Desk: 1-888-823-5923
• CTSU Regulatory Help Desk: 1-866-651-CTSU
• E-mail: CTSUcontact@westat.com
• Business hours:
– Monday - Friday,
– 9am – 5:30pm ET
• Phones are answered directly
• When phone lines are busy and on weekends and holidays, voice mailbox is available
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