The Essentia Institute of Rural Health has a dedicated department of professional clinical research registered nurses (RNs) clinical trials recruiter, clinical research specialists, clinical research coordinators, and clinical research assistants. All staff has experience, knowledge and education to conduct clinical trials according to U.S. Food and Drug Administration (FDA) regulations, Office of Human Research Protection (OHRP) guidelines and research clinical practice. Clinical trials are conducted at Essentia East (Duluth MN), West (Fargo, ND), and Central (Brainerd MN) sites.
Research nurses who meet professional certification criteria are certified by the Association of Clinical Research Professionals (ACRP), or the Society of Clinical Research Associates (SOCRA) Research assistants who qualify are certified by SOCRA.
The institute participates in Phase Ib-IV industry acute and outpatient device and investigational medication trials, device registries, national consortium research, and studies sponsored by the National Cancer Institute
All research is reviewed by the Essentia Health Institutional Review Board (IRB) for the protection of human subjects and the EIRH Scientific Review Board for scientific merit.
Verify the Essentia Health IRB with the Office for Human Research Protections
Clinical research facilities
The Essentia East clinical research facilities are based on the former SMDC Health System campus in downtown Duluth, MN and Essentia West Health South University Clinic in Fargo, ND.
Oncology NCORP studies are also offered at both Essentia West and Central locations. Most industry-sponsored research is administered from an office located in a building on the Essentia Health-St. Mary's Medical Center campus in Duluth. Laboratory, Investigational Drug Pharmacy, cardiac and cardiac device special procedure areas, and medical offices are accessible via skywalk.
Essentia Health laboratories has access to dry ice, PK capabilities and courier services. A -20° C and -70° C freezer with temperature-recording devices is available as well as ambient and refrigerated centrifuges and an alarm system. We have dedicated phlebotomy areas, both outpatient and hospital-based service, and a designated processing area. We are CLIA/CAP certified, and all staff is certified FFA/IATA.
Investigational product is stored in a limited access, secured investigational pharmacy. Refrigerator and freezer temperature are continuously electronically monitored with alarm; the room temperature is manually monitored. The pharmacy is staffed Monday through Friday by pharmacy staff and hospital-based study medication is available 24/7. The surgery pharmacy is staffed Monday through Friday by pharmacy staff.
The Essentia Health Ambulatory Infusion Clinic has accessible emergency equipment and BCLS/ACLS certified staff. The clinical studies departments provide CRF storage and staff experienced with a wide variety of electronic data capture systems.
Monitoring facilities have broad band high-speed Internet access as well as copy machines, FAX machines and phones. We have designated monitoring work space. Long term CRF storage is maintained for 15 years by EIRH staff at an off site storage facility
The electronic medical record (EpicCare) is available on computer and in paper form. It is FDA 21 CFR part 11 compliant. Study Monitors are required to complete EIRH medical record access training and will be provided with a password in order to view the electronic medical record.
Dedicated data entry staff have experience with the following electronic data capture systems; Phase forward-InForm, RAVE, Oracle, and a wide variety of other data capture systems .
Source documentation, Clinical Research files and regulatory binders are completed and maintained by clinical research staff and are kept in the locked clinical research trials office.
Processing of regulatory documents, contract and budget negotiation are managed at the Essentia Institute of Rural Health Administrative Office.
Essentia Health has healthcare facilities in 4 states: Minnesota, Wisconsin, North Dakota and Idaho. Essentia Health is a not-for-profit, 501(c)(3), integrated healthcare system with headquarters in Duluth, Minn. Currently Essentia has 17 hospitals, 62 clinics, 750 physicians, 1,000 credentialed practitioners, and 13,000 employees that care for approximately 900,000 patients. Our service area is mainly rural areas with small towns and cities. EpicCare electronic health record system is fully implemented in many facilities, and distributed care centers across these rural areas.
The Essentia Institute of Rural Health
On January 1, 2010, the Essentia Institute of Rural Health became a non-profit, 501(c)(3), within Essentia Health.
During a recent fiscal year, our research enterprise engaged over 1,800 human subjects in clinical trials or other studies, had 395 active research projects or clinic trials and received over $3.3 million in research grants and contracts with an additional $1.2 million of internal dollars spent on research.
Our sponsored, clinical research began in 1978 when the former Duluth Clinic and SMDC Health System (now part of Essentia Health) joined cancer clinical trials through the North Central Cancer Treatment Group funded by National Cancer Institute. An IRB and other research infrastructure were created the same year. In 1990 SMDC established a formal research division to perform clinical, translational, and health services research.
In June 2009, we implemented an operational, web-based Integrated Medical Research Information System (IRIS). The enterprise-wide application integrates scientific review, human subject protection, contract/grants management study and study management into one application. It is HIPAA compliant and provides efficiency for data input and maximum data availability for central oversight. This application can be easily extended for research enterprise management in all Essentia affiliates.
Essentia Health Information Services (EHIS)
Essentia Health Information Services has three main work groups located in Duluth, MN, (formerly SMDC Health System); Fargo, ND, (formerly Innovis Health); and Brainerd, MN, (formerly Brainerd Lakes Health). EHIS maintains four data centers located in Fargo, Brainerd, and two large facilities in Duluth that occupying more than 5,300 square feet of raised floor space. All four data centers are protected with uninterruptible power supplies (UPS), backup generators, fire suppression and N+1 cooling. The Duluth facilities form an active-active tandem that hosts redundant technology for the majority of applications and services. Wide area network and Internet connections are redundant in these two facilities. Also, Duluth campus buildings are served by redundant geographically diverse fiber paths and highly resilient chassis switches. Regional facilities are connected via high-speed private Ethernet, cable broadband and T-1 services.
EHIS delivers and supports over 500 applications; among these are electronic health record systems (Epic, Cerner and Meditech), Lawson Enterprise Resource Planning (ERP) as well as numerous ancillary and business support applications. The EHIS group also supports many custom built client-server and web-based applications. The web development group recently deployed a physician and executive portal spanning the entire organization. The portal provides a means of communication amongst physicians, credentialed practitioners and partners across Essentia Health. The Duluth IS group also maintains a complex HL7 data interface environment linking a large number of clinical and business applications on a variety of operating system and database platforms.