Office of Clinical Research (OCR)
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1 Office of Clinical Research (OCR) Your Partner in the Clinical Research Process h3p://bsdocr.bsd.uchicago.edu Phone: Susan L. Cohn, MD Dean for Clinical Research Professor of Pediatrics
2 OCR Created to further the research and health care mission of the Medical Center Develop and support specific components of infrastructure related to clinical research Enhance the excellence, scope, and efficiency of clinical research efforts Facilitate and integrate clinical research acqviqes Foster clinical research acqviqes in areas where they are not yet fully operaqonal
3 OCR Leadership Susan Cohn, MD Dean for Clinical Research Bethany Martell Director
4 The OCR s 5 Areas of Focus 1. EducaQon & Quality Assurance 2. Regulatory Compliance 3. Financial OperaQons 4. Clinical Research IT 5. Human Subjects ProtecQon- IRB
5 1. Educa:on & Quality Assurance I MulQple training opportuniqes for faculty and staff engaged in the conduct of clinical research IniQal training (select 1) required prior to conducqng IRB approved clinical research: CITI Human Subjects ProtecQon (Faculty & Staff) NIH Responsible conduct of Research (Faculty only) Fundamentals of Clinical Research or Graham School Clinical Trials Management CerQficate Course (Staff only) On- going educaqon: Quarterly OCR Workshops Provide updates on policies and procedures Highlight research conducted by our faculty For further informaqon, contact Chrystal Johnston at cjohnsto@bsd.uchicago.edu /
6 1. Educa:on & Quality Assurance II Performs internal audiqng to help idenqfy areas of concerns and provide targeted training Scheduled Audits as prioriqzed by OCR Ad Hoc Audits For Cause Audits PI Requests FDA Audit PreparaQons Billing Audits to ensure harmonizaqon of financial documents and accurate billing pracqces (Research vs SOC items) For further informaqon, contact Andrea Eiring at /
7 2. Regulatory Compliance I Study Submissions Assists PI in study submissions FDA applicaqon (IND/IDE applicaqon) Budget/billing submission Recruitment Strategies For further informaqon, contact Tet- Kin Yeo, PhD at tkyeo@bsd.uchicago.edu / ClinicalTrials.gov Assists PI in ClinicalTrials.gov compliance and CMS device billing approval For further informaqon, contact Andrea Eiring at aeiring@bsd.uchicago.edu /
8 2. Regulatory Compliance II Reviews new protocol submissions for compliance with financial and regulatory requirements HarmonizaQon of informed consent, protocol, schema and budget Conflict of Interest For internally or grant funded studies, contact Adaora Ogbuefi at / For industry- sponsored studies, contact Lorrie Romer at /
9 3. Financial Opera:ons I Oversees the research billing for clinical research protocols, verifies insurance regulaqons and ensures the integrity of paqent finances IdenQfy trends and analyze potenqal problem areas to ensure billing compliance IniQates correcqve acqon(s) to remedy discrepancies Processes payments for research billed clinical services For research related billing discrepancies and/or inquiries contact resbilling@bsd.uchicago.edu To create research payer guarantor accounts, resoutpt@bsd.uchicago.edu with paqent s name, medical record number, IRB# and department/secqon
10 4. Clinical Research IT Maintains the electronic systems used for data collecqon, reporqng and management of clinical research. Velos OCR Submission System Velos is the divisional Clinical Trial Management System. OCR Submission System (OCRSS) is for rouqng Internally- funded studies, CooperaQve group studies & individual studies under exisqng grants, which are not otherwise routed in AURA- Grants. For Velos, contact Ryan Crist at / For OCRSS, contact Olga Vachtchenko at /
11 5. Human Subjects Protec:on- IRB The BSD/UCMC IRB Reviews and approves all research involving human subjects Primary responsibility is to protect the rights and welfare of all research subjects, including volunteers and paqents Also serves as the HIPAA Privacy Commi3ee All research conducted by UofC faculty (regardless of where the study is performed) must be reviewed and approved by the IRB. Website: h3p://bsdirb.bsd.uchicago.edu/ /
12 IRB Leadership Christopher Daugherty, MD Chairman, IRB Millie Maleckar Director of Regulatory Compliance for Human Subjects Nell Thompson Associate Director of Regulatory Compliance for Human Subjects James Lynch Associate Director of Assurance
13 What does the IRB look for? Risks are minimized Risks are reasonable in relaqon to anqcipated benefits SelecQon of subjects is equitable Informed consent is properly sought (consent process) Consent is properly documented Adequate provisions for monitoring the data are present ProtecQons for privacy and confidenqality are ensured When vulnerable populaqons are likely to be included, safeguards are included to protect the rights and welfare of these subjects
14 Addi:onal Services of the OCR Sponsor- Inves:gator Study Implementa:on Program The ITM provides assistance and training courses which focus on the developing the scienqfic porqon of the clinical research and wriqng the protocol. The OCR created this new program to complement the resources provided by the ITM. This program will focus on the pracqcaliqes of iniqaqng and conducqng a study in compliance with Federal and local regulaqons
15 Sponsor- Inves:gator Study Implementa:on Program This new program includes providing assistance in: Feasibility assessment of the proposed study (Feasibility checklist, cohort idenqficaqon, other clinical research support contacts such as HIRO, CRC, CRI) FDA applicaqon (IND/IDE determinaqon and applicaqon) IRB submission (AURA- IRB navigaqon, Consent form development, Protocol development) Budget/Billing submission (Schema, concurrent rouqng documents, budget development) Recruitment strategies (demographics, adverqsement format, social media, paqent centricity models) For further informaqon, contact Tet- Kin Yeo, PhD at /
16 Clinical Research Process Study Initiation Pre-Study Resources & Dept. Contact Info Feasibility & Responsibility Document Templates & Tools Submission & Approval IRB Submission Contract, Budget & Billing Submission Review & Approval Process Activation Protocol-Specific Training Regulatory File Creation Study Registration Research Conduct Data Collection Data Quality & Patient Safety Monitoring AEs, SAEs, UPs Report Drug/Device Monitoring Billing Compliance Research Closeout FDA Reports IRB termination Billing Completion Contract Termination
17 Other Clinical Research Support Offices OCR collaborates closely with other Clinical Research Support Offices: University Hospital Pharmacy InvesQgaQonal Drug Service (IDS) The IDS provides assistance in storing and dispensing drug used in Clinical Trials hep://home.uchospitals.edu/portal/dt? JSPTabContainer.setSelected=TabHome&TabHome.setSelected=hiddenPageTableDisplayDocument&di d=uch_ Human Imaging Research Office (HIRO) HIRO s goal is to assist inves@gators and research staff with medical imaging performed on human subjects for clinical trials and research purposes. This includes sewng up imaging for clinical trials as well as the analysis, collec@on, anonymiza@on and distribu@on of image data heps://hiro.bsd.uchicago.edu/ Human Tissue Resource Center (HTRC) The HTRC is set up to provide a centralized infrastructure to op@mize the efficiency and costs related to research involving biospecimens hep://htrc.uchicago.edu/ Clinical Research Data Warehouse (CRDW) One of the crea@ons of CRI is CRDW whereby a protocol approved by the IRB that describes the standards, governance and oversight of the design, maintenance, and use of the CRDW. The approved protocol allows data from the CRDW to be provided for research. These data include lab values, procedure and diagnosis codes, demographics, medica@ons and visit informa@on. h3p://cri.uchicago.edu/?page_id=2736
18 New IniQaQve in Development UChicago Universal Registry and Biobank Protocol Will consent paqents for: Banking of lep- over blood and Qssue for future research Linking samples to clinical informaqon from the EHR (CRDW) Opportunity to re- contact the paqent for future research studies
19 Welcome to the University of Chicago
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