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Michigan Medicine Site Profile June 2021

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Michigan Medicine Site Profile June 2021 MICHIGAN MEDICINE SITE PROFILE JUNE 2021 CLINICAL TRIALS SUPPORT OFFICE | MEDICAL SCHOOL OFFICE OF RESEARCH 1. STATISTICAL HIGHLIGHTS 2. MICHIGAN MEDICINE OVERVIEW 3. COMPUTER & INTERNET 4. BUDGETS & CONTRACTS 5. PAYMENT & CONTRACTS 6. DEPARTMENT-SPECIFIC, FACILITIES, RADIOLOGY 7. LABORATORY, PHARMACY 8. IRB/REGULATORY 9. PARTICIPANT POPULATION 10. STUDY TEAMS, GENERAL MICHIGAN MEDICINE SITE PROFILE ALL SPONSORED PROJECTS Fiscal Year 2020 3,715 NUMBER OF ACTIVE AWARDS $662M AWARDS $556.8M EXPENDITURES Faculty FTEs >3.9k (3,948 Headcount) Average Number 1,043 of Operating Beds Diagnostic Imaging 624,811 Procedures Outpatient Clinic Visits, 2.4M Treatments, Procedures Total Employees >29k (Full Time) 1,407 498 ACTIVE NEW Clinical Trials Clinical Trials Michigan Medicine is a premier academic medical center made up of three hospitals with 60 subspecialties and more than 125 clinics throughout Michigan. In 2020-21, Michigan Medicine was named number 1 in Michigan. Michigan Medicine is a national research leader based on many measures, such as the scope and quality of its investigations and the size of its research portfolio. Michigan Medicine Overview In fiscal year 2020, our sponsored research reached $662 million. Michigan Medicine is committed to improving clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. To that end, Michigan Medicine created an organizational structure to better support the conduct of clinical trials, including a central Clinical Trials Support Office (CTSO) with seven affiliated Clinical Trial Support Units (CTSUs) that provide robust infrastructure, training, and oversight for studies performed at U-M. The seven Clinical Trial Support Units are business units that partner with investigators and their teams to ensure the timely and efficient activation and execution of clinical trials. Clinical Trials Support Units (CTSUs) are trans-departmental and thematically aligned based on research foci. These local units provide comprehensive support to study teams, offering high-quality and efficient service in support of a mix of clinical trials. The CTSUs provide a professional environment of expert personnel accessible to all investigators, especially early- career faculty. The central CTSO provides enterprise-wide standards, policies, and a common infrastructure that is utilized by the units and study teams. Acute, Critical Care, Surgery & Transplant CTSU provides Children’s CTSU specializes in clinical trials for pediatric infrastructure to study time-sensitive, unscheduled clinical subjects. The unique needs of children and their families are interventions in the emergency medical services system, the focus of this CTSU, and provides enhanced support to a emergency department, critical care unit, transplant, or variety of pediatric clinical trials, including but not limited to studies conducted in an acute hospital setting. pediatric disciplines such as hematology/oncology, intensive care, nephrology, neurology, and endocrinology. Ambulatory & Chronic Disease CTSU is the home for all chronic, non-ICU diseases in the non-ICU adult population Heart, Vessel, Blood CTSU enhances performance of (excluding cancer and cardiovascular disease). These cardiovascular, coagulation, and nonmalignant hematologic diseases constitute the majority of clinical trials in the clinical trials across the lifespan of acute and chronic disease. ambulatory Internal Medicine divisions (rheumatology, endocrinology, pulmonary, geriatrics, nephrology, and Neurosciences and Sensory CTSU is a multidisciplinary, gastroenterology) and the Department of Ophthalmology multi-departmental CTSU that aims to provide a full range of & Visual Sciences which account for a large number of the services for investigators with clinical trials related to the skin ambulatory trials within Michigan Medicine. or nervous system. The CTSU is open to all faculty within the departments of Neurology, Neurosurgery and Dermatology, Behavior, Function, and Pain CTSU represents along with faculty outside these departments who find a investigators who conduct trials that involve behavioral natural fit with the CTSU theme. interventions or behavioral or biomedical trials intended to impact the following types of outcomes: health behaviors Oncology CTSU serves as the centralized core facility of all (physical activity, self-management), psychological states oncology clinical research trials conducted by investigators (e.g. mood, anxiety), maladaptive behaviors (e.g. substance at the University of Michigan Rogel Cancer Center and the use, eating disorders), physical function (e.g. recovery from Michigan Medicine community. As an NCI Comprehensive stroke, rehabilitation therapies), psychosocial function, or Center, the unit operates under the guidance of the Clinical pain. Protocol and Data Management component of the P30 grant. 2 JUNE 2021 MICHIGAN MEDICINE SITE PROFILE Computer & Internet How is access to the study data controlled? External File Sharing: Michigan Medicine recommends that shared users are required to use their unique credentials, and files are authorized through the use of MiShare. MiShare when working remotely, access the network through is a secure collaborative file transfer system that provides the secure Virtual Private Network (VPN). a method approved by the Michigan Medicine Compliance Office for Michigan Medicine personnel, non-Michigan How do Clinical Research Associates (CRA/Monitors) Medicine business partners, patients, and researchers to access secure study data? Unique user IDs are used securely transfer files, including files that contain electronic to access the Electronic Medical Record (EMR) with an Protected Health Information (ePHI), protected research appropriate role assigned. This allows view access to a data, or other sensitive information. Files are encrypted limited number of records for a limited time period. while being uploaded or downloaded and are encrypted while they are on the MiShare server. Other approved Can the Clinical Research Associate (CRA/Monitor) platforms for ePHI includes Box and Dropbox. connect to the internet while on-site? Yes, the Clinical Research Associates (CRA/Monitor) are permitted access Has the information system for the study undergone to the internet through the wireless networks. a security assessment and received authorization to operate from an appropriate authority? Yes, it is the What is the preferred wireless network? MWireless is the policy of Michigan Medicine to ensure the confidentiality, preferred network for employees for internet access and integrity, and protections of all sensitive data, including two-factor, Duo weblogin authentication, is required. ePHI. Security assessments are conducted by the office of the Chief Security Officer and research systems containing Can the Clinical Research Associate (CRA/Monitor) ePHI are required to have IRB approval, a risk assessment, access the Electronic Medical Record (EMR) to and authorization to operate. verify that source data is accurate? Yes, the Clinical Research Associates (CRA/Monitor) will be able to access Do you have an EMR (Electronic Medical Record) the EMR through our Michigan Medicine provider portal. available? Yes, we operate our Epic EMR system in line with federal, state, and local regulations, including Are all research personnel who are supporting the application of the NIST 800-53 family of controls. Epic study trained on the proper handling of sensitive data? is considered 21 CFR Part 11 compliant for electronic Yes, formal awareness training is required for all employees, records and signatures. contractors, sponsors, and other parties. There are documented disciplinary policies for violations of privacy Is the information system used by the study built upon a or security of protected health information (PHI) or other secure baseline configuration? Yes, underlying information sensitive data. systems supporting clinical trials management are set up in the Michigan Medicine infrastructure to meet institutional Are all accesses to ePHI, including view-only, logged? information assurance and security requirements. Yes, including who performed the access, what was accessed, and when the access occurred. Are changes to the information system(s) tracked? Yes, underlying information systems supporting clinical trials Are there CD-ROM drives available? Information on management have change control processes in place to CD-ROM access can be provided by the CTSU. Only test, approve and document changes. FIPS 140-2 Michigan Medicine-approved removable media can be used. Are study users required to have secure accounts that are managed by a central authority? Yes, in order to use information systems, users are required to have a unique ID managed by an Identity and Access Management team. How is the information system maintained? Systems are regularly maintained along their lifecycle from design, implementation, and operation to retirement. JUNE 2021 3 Budgets & Contracts The University of Michigan Office of Research and Sponsored Projects (ORSP) enables and safeguards the conduct of research and other sponsored activities for U-M. ORSP is responsible for activities such as contract negotiations of terms and conditions and facilitating the award as part of the U-M Office of Research. A second unit, the Office of Sponsored Programs, primarily oversees financial accounting to ensure compliance with applicable laws and sponsor regulations, such as allowed expenses
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