Transcript CTSU Basics

ACRIN Presentation
Cancer Trials Support Unit
Basics
September 21, 2011
Martha Hering, RN, CCRP
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What is the CTSU?
• 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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Background
• 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 (2nd) 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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CTSU Currently Supports
NCCTG
NCIC-CTG
NSABP
North Central
Cancer Treatment
Group
National Cancer
Institute of Canada
Clinical Trials Group
National Surgical
Adjuvant Breast
and Bowel Project
SWOG
ECOG
GOG
Southwest
Oncology Group
Eastern Cooperative
Oncology Group
Gynecologic
Oncology Group
CALGB
RTOG
Cancer and Leukemia
Group B
Radiation Therapy
Oncology Group
COG
IBCSG
Children’s Oncology
Group
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International Breast Cancer
Study Group
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ACOSOG
American College
of Surgeons
Oncology Group
Other NCI Funded
Research…
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CTSU Services
• Basic Non-menu
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Regulatory Support Services
Financial Services
OPEN
CDMS Support Center
IT Development
• Basic Menu
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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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CTSU Services for ACRIN
• Initial services that ACRIN will utilize:
– Institution and Person Roster Support
• CTEP-IAM and IR registrations
• Single Sign-on integration
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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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CTSU Web Site
• 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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Registration Tab – CTSU Public Site
CTEP-IAM
Fact Sheet
CTEP-IAM Link
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CTEP Account Registration
• 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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Steps to CTEP IAM Registration
• 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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Viewing Roster Data
• 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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Site & Person Roster Data
Institution and Person
roster associated with
user
Person
summary
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Site Roles Tab
Can view
persons by
roster
On the CTSU roster
persons with the
Site DA and AD
roles can assign
additional roles
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CTSU Regulatory Support Service
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Regulatory Support Services
• 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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Regulatory Support Services
• 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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Regulatory Submission Requirements
• 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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CTSU IRB
Certification
Form
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Checking Protocol Specific Requirements
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Timeframe for Regulatory
Document Submission
• 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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Submission Guidelines
• 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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Viewing Site Registration Data
Enter Site Code
User can filter
for status
Registration status
& missing
requirements are
listed
Link will provide detailed
protocol requirements list
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Viewing Site Protocol Requirements
Requirements list,
site status per
requirement
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Viewing Status Notifications
Approval
expiration notice
and expired
approvals
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CTSU Education and Resources
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Education and Resources
• 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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Education and Resources Page
Process
Flow sheets
Protocol-specific
materials
Audit
worksheets
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Protocols
OPEN
Clinical Data
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Protocol Services
• 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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Protocol Tab
• 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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Protocol Tab
My
Favorites
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Access to Broadcast,
Newsletters, protocol
updates and reports.
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Benefits of OPEN
• 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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OPEN Tab
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Clinical Data Management Services
• 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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Clinical Data Tab
• 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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Clinical Data Tab
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Support Services
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CTSU IT Services
• 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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Financial Services
• 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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CTSU Customer Service
• 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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Contact Information
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Contact the CTSU
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CTSU Help Desk: 1-888-823-5923
CTSU Regulatory Help Desk: 1-866-651-CTSU
E-mail: [email protected]
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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Questions?
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