ACRIN Presentation Cancer Trials Support Unit Basics September 21, 2011 Martha Hering, RN, CCRP 21...

ACRIN Presentation

Cancer Trials Support Unit Basics

September 21, 2011Martha 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

ECOGEastern Cooperative

Oncology Group

SWOGSouthwest

Oncology Group

NCCTGNorth Central

Cancer Treatment Group

NCIC-CTGNational Cancer

Institute of CanadaClinical Trials Group

ACOSOGAmerican College

of Surgeons Oncology Group

CALGBCancer and Leukemia

Group B

NSABPNational Surgical Adjuvant Breast

and Bowel Project

RTOGRadiation Therapy

Oncology Group

GOGGynecologic

Oncology Group

IBCSGInternational Breast Cancer

Study Group

Other NCI Funded Research…


COG Children’s Oncology

Group

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CTSU Services• 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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CTSU Services for ACRIN

• 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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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 Link

CTEP-IAM Fact Sheet

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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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• 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

Steps to CTEP IAM Registration


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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 DataInstitution and Person roster associated with

user

Person summary


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Site Roles TabCan view

persons by roster

On the CTSU roster persons with the Site DA and AD roles can assign additional roles

Martha Hering

delete

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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.21 Sept. 2011 ACRIN Presentation

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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


User can filter for status

Registration status & missing requirements are

listed

Link will provide detailed protocol requirements list

Enter Site Code

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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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• 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

Education and Resources

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Education and Resources Page

Process Flow sheets

Audit worksheets

Protocol-specific materials

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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 Bi-monthly Broadcasts

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Protocol TabMy

Favorites

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

• 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?Questions?

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ACRIN Presentation Cancer Trials Support Unit Basics September 21, 2011 Martha Hering, RN, CCRP 21...

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