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Profiles of a Clinical Trials Office

Learning Objectives. Identify necessary elements, staffing resources and activities for a robust clinical trials infrastructureLearn how to:define your institutions clinical trials infrastructure needsestablish a comprehensive clinical trials oversight programidentify potential areas of problems, standardize communications and resolve clinical trials issuesevaluate your institutional compliance with all aspects of 45 CFR 46.

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Profiles of a Clinical Trials Office

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    1. Profiles of a Clinical Trials Office Presentation time 10:30- Noon. 10:30-11:30 Presentation ~15 minutes each center 11:45-Noon open for questionsPresentation time 10:30- Noon. 10:30-11:30 Presentation ~15 minutes each center 11:45-Noon open for questions

    2. Learning Objectives Identify necessary elements, staffing resources and activities for a robust clinical trials infrastructure Learn how to: define your institutions clinical trials infrastructure needs establish a comprehensive clinical trials oversight program identify potential areas of problems, standardize communications and resolve clinical trials issues evaluate your institutional compliance with all aspects of 45 CFR 46

    3. Overview Explain why centers are supporting/organizing centralized offices Provide description of (3) different clinical organizations participating in clinical research Structure of the organizations clinical research infrastructure Lessons we’ve learned through development and implementation of the infrastructure Communication techniques utilized Current projects and next steps for the organizations How do you define your own institution’s needs

    4. Why have a centralized Clinical Trials office? Research Participant Involvement Research Coordinator Certification Journal of Negative Results Increased federal oversight Lawsuits International arena Increased regulatory oversight of clinical research:

    5. Memorial Sloan-Kettering Cancer Center New York, N.Y.

    6. Overview of the Cancer Center Main Campus Outpatient Pavilion @ 53rd St Breast Center @ 64th Street Sidney Kimmel Center @ 68th Regional Network Sites in Long Island, Westchester and New Jersey Main hospital, Urgent Care, In-Patient and Out-Patient Services, Zuckerman Research Building Adult out-patient services (primarily solid tumor), Pre-admission testing, Diagnostic Imaging Surgical and Medical Oncology, Diagnostic Imaging Surgical and Medical Oncology, Diagnostic Imaging for Urologic Ca Adult out-patient services in medical oncology, surgical oncology and radiation oncology, Diagnostic Imaging

    7. Clinical Research Environment State-of-the-art Outpatient Facilities (OPF) NYC based OPF’s are located within 1–15 blocks of the main campus Regional Network OPF’s are located between 20-55 miles from the main campus Operates as a ‘Paperless’ Environment: Clinical Care Standards Clinical Research Database (CRDB) Electronic Medical Record (EMR) Order Entry/Management System Digitized Radiology (PACS) Intranet-based IRB Protocol Web Application Protocol Information Management System (PIMS) MSK Intranet-based Clinical Research Portal

    10. Organizational Structure

    11. OCR Personnel by Division

    12. New Initiatives Expansion of educational programs and information access Creation of Clinical Research Web Portal New program geared towards Junior Faculty Enhanced and expanded educational opportunities for research staff Re-design of all research related web-sites Enhance Research Billing Processes Expand user functionality of system (ARC) Standardize budget process for internal and externally sponsored trials Close financial loop with Research Administration

    15. Sutter Institute for Medical Research Sacramento, CA Overview of Center Located in Downtown Sacramento, CA Investigator Staff-Private MDs, Foundation Groups, Private Groups Research Portfolio History of Clinical Trials Office Founded in 1959 at Sutter Memorial Hospital with research resulting in the Cutter-Smeloff heart valve, SIMR now serves the Sacramento-Sierra Region. Mission Statement:: To integrate research into clinical care

    16. Organizational Structure

    17. Sutter Health

    18. Geographic Scope

    19. SIMR Centralization Amidst Decentralization Decentralization: Sutter Health encourages affiliates to keep their own special identities. Multiple administrative approvals required. Multiple physician office structures to navigate. Multiple individual policies embedded in the Health System’s overall policies. Research Centralization: Designated Chief Administrator, Medical Director and Administrative Director to represent research. Centralized research tasks and responsibilities. Physician Champions (point persons throughout region)

    20. SIMR Centralized Office Structure Administrative Budget/Contract Process Clinical Trials Finances Management Billing Compliance Sponsor Relations Investigator Recruitment Quality Assurance (Study Monitoring and Auditing) Clinical Trials Study Management Patient Recruitment Centralized Patient Database Call Center Database Development (Research Specific) EPIC Electronic Medical Record Velos e-Research Database

    21. SIMR Research Areas and Study Activity Sutter Institute for Medical Research: General Medicine Trials -45 Investigator Initiated Trials – 10 Sutter Heart Institute: Cardiovascular Trials – 12 Sutter Neuroscience Institute: Inpatient Stroke Trials - 4

    22. SIMR Future Growth SIMR Growth Increase Principal Investigators Standardize Contracts Tract Manager Master Contracts Continued Development of Technology Increase Quality Assurance and Control Sutter Health Growth Centralized Sutter-wide Research Sites-Sponsor Study Feasibility Process

    23. Hospital for Special Surgery New York, NY

    24. Organizational Structure

    28. New Initiatives HSS Evaluating level of ICH compliance Gap Analysis Projects Research-related charges Further developing home-grown application Clinical and Translational Science Award (CTSA)

    29. Summary

    30. Clinical Trials Office Infrastructure Dog and pony Regular communications (emails, postings, individual meetings; attend service or faculty meetings, web site updates, newsletters) Identify the players (key researchers, existing staff; ancillary department contacts) Dog and pony Regular communications (emails, postings, individual meetings; attend service or faculty meetings, web site updates, newsletters) Identify the players (key researchers, existing staff; ancillary department contacts)

    31. Questions? Join us for the afternoon discussion: Date: November 5th, 2007 Time: 3:30- 5:00pm Location: TBD Topic: Clinical Trials Office – Best Practice discussion on Data Management / Monitoring/ Audit/ “Costing” FDA and ICH Compliance Non-Standard of Care (i.e. “research”) Charges Monitoring at sites geographically apart or in different environments: private practice, hospitals

    32. Contact Information Collette Houston, Memorial Sloan-Kettering houstonc@mskcc.org Linda Marks, Sutter Health – Sacramento marksl1@sutterhealth.org Meaghan Reyes, Hospital for Special Surgery reyesm@hss.edu

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