2. ACRIN Presentation Cancer Trials Support Unit Basics September 21, 2011 Martha Hering, RN, CCRP 21 Sept. 20111ACRIN Presentation

3. 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. 21 Sept. 2011ACRIN Presentation2

4. 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) 21 Sept. 2011ACRIN Presentation3

5. CTSU Currently Supports ECOG Eastern Cooperative Oncology Group SWOG Southwest Oncology Group NCCTG North Central Cancer Treatment Group NCIC-CTG National Cancer Institute of Canada Clinical Trials Group ACOSOG American College of Surgeons Oncology Group CALGB Cancer and Leukemia Group B NSABP National Surgical Adjuvant Breast and Bowel Project RTOG Radiation Therapy Oncology Group GOG Gynecologic Oncology Group IBCSG International Breast Cancer Study Group Other NCI Funded Research… 21 Sept. 2011ACRIN Presentation4 COG Children’s Oncology Group

6. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation5

7. 6 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) 21 Sept. 2011ACRIN Presentation6

8. 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 21 Sept. 2011ACRIN Presentation7

9. 21 Sept. 2011ACRIN Presentation8 Registration Tab – CTSU Public Site CTEP-IAM Link CTEP-IAM Fact Sheet

10. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation9

11. 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 21 Sept. 2011ACRIN Presentation10

12. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation11

13. ACRIN Presentation Site & Person Roster Data Institution and Person roster associated with user Person summary 21 Sept. 2011ACRIN Presentation12

14. ACRIN Presentation 21 Sept. 2011ACRIN Presentation13 Site Roles Tab Can view persons by roster On the CTSU roster persons with the Site DA and AD roles can assign additional roles

15. ACRIN Presentation 14 CTSU Regulatory Support Service 21 Sept. 2011ACRIN Presentation

16. 15 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. 2011ACRIN Presentation

17. 16 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) 21 Sept. 2011ACRIN Presentation

18. 17 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) 21 Sept. 2011ACRIN Presentation

19. 18 CTSU IRB Certification Form 21 Sept. 2011ACRIN Presentation

20. Checking Protocol Specific Requirements

21. ACRIN Presentation 20 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.http://members.ctsu.org/ The user can look up RSS Site Registration Status or RSS Site IRB Expiration Status 21 Sept. 2011ACRIN Presentation

22. 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 21 Sept. 2011ACRIN Presentation21

23. ACRIN Presentation Viewing Site Registration Data 21 Sept. 2011ACRIN Presentation22 User can filter for status Registration status & missing requirements are listed Link will provide detailed protocol requirements list Enter Site Code

24. ACRIN Presentation 21 Sept. 2011ACRIN Presentation23 Viewing Site Protocol Requirements Requirements list, site status per requirement

25. ACRIN Presentation Viewing Status Notifications 21 Sept. 2011ACRIN Presentation24 Approval expiration notice and expired approvals

26. ACRIN Presentation CTSU Education and Resources 21 Sept. 201125ACRIN Presentation

27. 21 Sept. 2011ACRIN Presentation26 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

28. ACRIN Presentation 21 Sept. 2011ACRIN Presentation27 Education and Resources Page Process Flow sheets Audit worksheets Protocol-specific materials

29. ACRIN Presentation Protocols OPEN Clinical Data 21 Sept. 201128ACRIN Presentation

30. 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 21 Sept. 2011ACRIN Presentation29

31. ACRIN Presentation 21 Sept. 2011ACRIN Presentation30 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

32. ACRIN Presentation 21 Sept. 2011ACRIN Presentation31 Protocol Tab My Favorites Access to Broadcast, Newsletters, protocol updates and reports.

33. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation32

34. ACRIN Presentation 21 Sept. 2011ACRIN Presentation33 OPEN Tab

35. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation34

36. ACRIN Presentation 21 Sept. 2011ACRIN Presentation35 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

37. ACRIN Presentation 21 Sept. 2011ACRIN Presentation36 Clinical Data Tab

38. ACRIN Presentation Support Services 21 Sept. 2011ACRIN Presentation37

39. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation38

40. ACRIN Presentation 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 21 Sept. 2011ACRIN Presentation39

41. ACRIN Presentation 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. 21 Sept. 2011ACRIN Presentation40

42. ACRIN Presentation Contact Information 21 Sept. 201141ACRIN Presentation

43. 42 Contact the CTSU CTSU Help Desk: 1-888-823-5923 CTSU Regulatory Help Desk: 1-866-651-CTSU E-mail: CTSUcontact@westat.comCTSUcontact@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 21 Sept. 2011ACRIN Presentation

44. 21 Sept. 201143 Questions? ACRIN Presentation