University of Chicago Protocol Review and Approval Process

1. Departmental Clinical/Translational Research Support Offices** PI/CRSO Prepares IRB submission (Other committee’s forms completed as needed) PI works with Contracts Manager To distinguish Research from Standard Charges OCR comments on harmonization of schedule of events, informed consent, protocol and agreement Comments addressed and Revised submission forwarded to IRB Reviewer Full Committee Review: Committee determination: Approved, Pending/Conditional Status, Deferred Response, if applicable, received and Reviewed by IRB Departments/PI forward budget and agreement to OCR and URA for review Regulatory Review Financial, Compliance, Administrative Institute for Translational Medicine Clinical Trials Cluster Contract Execution Process Best and Final Agreement Routed for signatures 1-2 weeks Administrative pre-review comments Sent to PI/CRSO PI or Contracts Manager develop Budget and negotiate with Sponsor URA negotiates contract language With Sponsor IRB Approval Process To be done In parallel 1-3 weeks 3-5 weeks RSA Program Research Subject Advocates Scientific Review Committees* University Research Administration** IRB Approval Issued Protocol/ Contract Approved Institutional Review Board Biostatics Research Ethics Consultation Epidemiology Clinical Epidemiology Health Outcomes Pipeline Training T32 PhD/MS Programs K12 Research Training + MS K30 Research Training + MS CTSA Training Council University of Chicago Protocol Review and Approval Process Bethany L. Martell, Julian Solway, Lainie Ross, Richard L. Schilsky, Susan Cohn, Katie L. Arrigo, and Walter M. Stadler The structure of the Clinical Translational Science Award at the University of Chicago includes four clusters with the Clinical Trials Cluster focused on the execution of clinical and translational research within the Biological Sciences Division and the Medical Center. Principal Investigators have generally perceived the review and approval process to be overly complicated. • Assessing and redesigning the protocol routing and approval process included efforts to identify meaningful metrics. • Challenge: What do we want to measure? • The ease of the submission -This is very subjective • The quality of the data submitted -This is also very subjective • The speed of routing a new protocol through the system -When do we start the clock? • Given the currently decentralized process, we track processing time from three points: • Schema to BAFO • Schema to IRB Approval • IRB Approval to BAFO • -Schema reflects date PI determined designation of charges • -BAFO (best and final offer) reflects date final contract signed PI PERSPECTIVE OF CLINICAL RESEARCH INFRASTRUCTURE Clinical Research Policy Board University Research Administration Conflict of Interest Office of Clinical Research Sectional/Programmatic Research Office INSTITUTE FOR TRANSLATIONAL MEDICINE Solway/Ross CTSA External Review CTSA Advisory Board Office of Research Services Office of Medical Center Compliance INVESTIGATOR IRB ITM Executive Committee Director, Co-Director, Assoc Directors Cluster Leaders, ANL and IIT Reps Dirs of UCCRC, CCTS, CDPH, IDPH Office of Clinical Research C/T Research Support Office Subject Recruitment Core Research Subject Advocacy Community Connections Community-Based Participatory Research Practice-Based Research Knowledge Translation Sponsor Scientific Review Committee CMS & Private Insurance FDA Funding Agency Community Translational Science Cluster Ewigman/Gehlert Clinical Trials Cluster Schilsky/Cohn/ Stadler • For sponsored clinical trials the recommendation has been for concurrent submission of • Regulatory and financial documents to the OCR • IRB documents to the IRB A snapshot of data from 2007 Population Sciences Cluster Thisted/Ross Core Support & Technology Cluster Weiss Sponsored Clinical Trial Processing Time+ CY 2007++ The following data reflect three aspects of processing time for which the number of days are considered. The numbers in the first 5 columns represent the occurrence of protocol/contracts within the given time frame. The last column reflects the average number of days. Training Cluster - Garcia (Meltzer/Olopade) 16 Patient and “Wet” Cores Core Technology Incubator Pilot & Collaborative Projects Internal Sci Advisory Panel Biomedical Informatics Core • The Office of Clinical Research (OCR) is the support office for the Clinical Trials Cluster. At the divisional level the OCR oversees various components of clinical research including regulatory, financial, human subject safety, and institutional infrastructure. • The CTSA has served as a catalyst for assessing the process by which we conduct the start up, approval, and activities of clinical and translational research. In particular the following areas have been considered: • Mapping current operations in the process of protocol throughput; • Identifying duplication and key stakeholders; • Designing streamlined and effective pathways for improving the accuracy and quality of submissions while decreasing the time to review and approval. + Does not include protocols without a contract. ++ Days reflect business days * Schema reflects date PI determined designation of charges ** BAFO (best and final offer) reflects date final contract signed • Lessons Learned • As we refine our metrics we would like to consider how to obtain more comprehensive data that will include all of the offices which are involved in the execution of these processes. To this end: • We must have a well defined review and approval process • We need to have buy-in from the process owners • We need to measure what matters • We need to act on the findings to improve the process • We need to have accountability for the results ideally by having the process owners report their own metrics • Challenge: While this recommendation has been in place for many years • There are no mechanisms to ensure that this happens • Additionally, even if it did occur simultaneously, the responsible offices do not have formal procedures • for collaboration and integration of comments and/or requested revisions Our current and more streamlined proposal. Division/Medical Center University Department Human Subjects Protection (IRB) Grants (ORS) • Goals for the OCR • Support the CTSA Clinical Trial Cluster • Streamline clinical research operations • Improve compliance with federal, state and local regulations regarding clinical research • Educate and mentor research faculty and staff • Provide infrastructure and tools for performing efficient and high quality clinical research • Oversee development, implementation, and reporting of internal and external metrics Quality Assurance Education S P O N S O R Department Center/ Section (PI & CRSO, CRC, or budget/contracts, regulatory managers) Financial and Administrative Regulatory Review (OCR) Contract Negotiations (URA) OCR IBC Office of Clinical Research RadRac HIPAA Office (G)CRC IDS (Pharmacy) Nursing Research Pharm Sample RC *includes Core Support and Technology scientific review which encompasses Clinical Resource Center (formerly General Clinical Research Center) **groups which are external to the OCR The OCR and IRB have merged and all submissions will go to one division: the OCR. All offices within the circle are coordinated.