Center for Clinical Research SPACE AND PARTICIPANT INTERACTIONS Clinical Research Units, Nursing, Nutrition, Specimen Processing, Assays RECRUITMENT SERVICES Consultation, advertising, screening FINANCIAL SERVICES Budget preparation, review, and reconciliation Key Personnel Lewis Smith, MD Ken Gordon, MD Roz Ramsey Goldman, MD Leon Epstein, MD Peggy Mitchell Tom Hancko* David Johnson, PhD Kelly Carroll, PhD* Barb Ferry* *Clinical *Clinical Research Research Navigator Navigator REGULATORY SERVICES IRB, IND/IDE, ClinicalTrials.gov COORDINATOR SERVICES Nurse/non-nurse, data management NMH, LCH, NLFH, North Suburban Initiative TRAINING & FEASIBILITY SERVICES Feasibility review, QA, DSMB, GCP
CCR Linked to CTSA RFA Facilitate the efficient implementation of clinical studies Broad culture of responsibility for safe/ethical conduct of human subjects research Ensure that high quality research is conducted Tracking of enrollment, steps to ensure the timely assessment of feasibility and closure of studies that do not meet goals, efficient institutional workflows for conduct of translational studies Availability of highly trained study staff and ancillary services, and timely submission of adverse events. Willingness to adopt centralized IRB arrangements Cooperation and coordination among the data stewards in various organizations and institutions on policy issues 2
CCR Vision and Proposed Model Vision: Accelerate the translation of scientific discoveries into healthcare solutions by performing more high impact research faster, more effectively and safely, and with improved financial outcomes YESTERDAY TODAY/TOMORROW CRRC Infrastructure Low High Limited communication No process standardization Many depts. with limited clinical research infrastructure #1 #2 #3 #4 #5 Lurie Cancer Center CRO BCVI CTU #6 Neuro Size Approximates # Trials CRRC Infrastructure Low High Strong communication CCR provides optional centralized services CCR leads standard training, IT and measurement functions #5 BCVI CTU CCR [ #1-4] #6 Lurie Cancer Center CRO Neuro Low Productivity / Efficiency High Low Productivity / Efficiency High *Graphs are intended to illustrate the CCR vision and do not reflect actual data
CCR What Can it Add Coordinate communication about and responses to clinical research challenges Study recruitment/enrollment Budget development and reconciliation (e.g., collections) Time to open studies (e.g., IRB, OSR) Compliance regulatory (e.g., GCP, CT.gov); billing Harmonize policies, procedures, and best practices across the clinical research enterprise Provide services to all clinical research studies Catalogue clinical research space and services at Northwestern and beyond
CCR Already Achieved (highlights) Engaged broad constituency investigators, coordinators, administrators, etc. Management dashboard built and partially implemented Study feasibility form being tested Recruitment web site, 800 number and standard recruitment form PI portal received scoping and budget First use of 3 rd party IRB for NIH (NeuroNEXT) and industry studies (Gordon, Flamm, Ruderman) New financial model for CRU
CLINICAL STUDY FEASIBILITY PI Staff Participants Competing studies Space Equipment, other resources Budget
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Draft Budget Template
CCR Planned Links to key financial data via EDW Require study feasibility assessment by PI Mandatory new coordinator training Process improvement projects - IRB, OSR, recruitment Expand services - recruitment, budget, biostatistics (ClinicalTrials.gov results reporting) IT management dashboard, PI portal/web application form Business development
Building a management dashboard to support clinical research advancements EDW dashboard designed to track key metrics aligned with the Center for Clinical Research s vision Study Volumes Enrollment Metrics Cycle Times Financial Outcomes Others