Clinical Research Resources
Clinical Research Resources
Clinical Trial Management Services
Berman Center for Outcomes & Clinical Research
Since joining the HHRI in 1997, the Berman Center has been a leader in cardiovascular research and a clinical site for dozens of trials in heart and kidney disease, diabetes, women's health, cancer, aging, and neurological disorders. The Berman Center is experienced in study design, implementation and analysis and has been -and is- a clinical site, an International Coordinating Center and Academic Research Organization (ARO). As an ARO, Berman provides scientific rigor and credibility through partnerships with academia. Berman has extensive experience proposing and recruiting sites through established networks and relationships and can implement all aspects associated with starting and managing a successful study. As such, the Berman Center is ideally suited to guide new investigators in any and all aspects of clinical research or provide a research infrastructure for those investigators who may not currently have one.
For more information about working with the Berman Center, please contact Brenda Kirpach at email@example.com or 612-873-6905. You can also visit our website at BermanCenter.org.
Clinical Trials Standard Operating Procedures
The Clinical Trials Standard Operating Procedures are implemented and maintained by the Office of Education & Quality in Clinical Research (OEQCR) as part of its commitment to ethical research practices and the protection of subjects who consent to participate. The provided services of the OEQCR are multifaceted and can vary with the specific request of the investigator or staff. Examples of provided services can be found on their page.
- 2.1 Research Team Responsibilities (PDF)
- 2.2 Management of Regulatory Files (PDF)
- 2.3 Pre-Study Protocol Evaluation (PDF)
- 2.4 Pre-Study Feasibility Evaluation (PDF)
- 2.5 Developing a Budget (PDF)
- 2.6 Pre-Study Site Evaluation Visit (PDF)
- 2.7 Study Start-Up (PDF)
- 2.8 Study Initiation Visit (PDF)
- 2.9 Subject Recruitment and Screening (PDF)
- 2.10 Obtaining Informed Consent
- 2.11 Study Conduct (PDF)
- 2.12 Study Close-Out (PDF)
Remote Study Visits
Remote or in-home patient visits can be employed by research staff in all programs, especially once a patient has been discharged, to help maintain the integrity of study data. HHRI and HCMC researchers may choose to engage in remote work in one of three ways: by either utilizing study staff, requesting community paramedic services, or contracting with an external vendor. Details on the proper application of each method are outlined below. Please see the Use of Remote Visits for Research Guidelines for further information on implementation and billing processes.
In order to request use of remote services, the study team should complete the Remote Visit Request Form and submit it to the Office of Grants and contracts. Please note that PIs and/or study staff should also complete the HHS Resource Utilization Checklist for their study to better ascertain what services can be provided remotely. Once a determination has been made, HHRI Grants and Contracts staff will work with the study team to utilize first internal services, or – if such services are not available or applicable to the project in question – external services to fit the study team’s research needs.
Study Provided Services
If feasible and applicable, research teams can utilize members of their own staff for mobile patient visits. HHRI insurance coverage extends to any work done by a study team member, whether remotely or on campus, to complete research activities as part of their position at HHRI. Please keep in mind that any requests for mileage reimbursement must follow HHRI Business Expense Guidelines and be recorded using the Mileage Reimbursement Request Form. Also, current guidelines set by the Minnesota Department of Health regarding health emergencies must be taken into consideration when coordinating remote visits and all associated safety measures.
Internal Services (Community Paramedics)
Researchers may also make an internal request for community paramedics to perform study services through Hennepin Healthcare. It is important to note that, while community paramedics can provide basic medical services like lab draws or physicals to patients in person, they cannot complete any research-related work for the study team, such as questionnaires or surveys. Community paramedics reserve the right to review all internal requests and limit their services depending on the project’s specific time and scope requirements. In addition, the availability of community paramedics can be limited, so research staff should be prepared to work directly with paramedics to ensure all services can be administered within their specific working hours and area of coverage.
External Services (MN Mobile Exams)
If the above internal options do not match the needs of particular study, HHRI has a master agreement with external contractor MN Mobile Exams to provide in-home patient services for research projects. In order to implement this option, the study team must have a completed Statement of Work on file with the Office of Grants and Contracts and agree not to begin any work until an official SOW # has been received from the study’s Grant Administrator. A Mobile Visit Request Form will be sent to the study team once the SOW is finalized and must be used to request visits from the external vendor to ensure the company has all required information to provide appropriate patient services as well as bill the study team appropriately for time spent.
HHS Clinical Services for Research
Medical research is an important priority for HHS, and as a subsidiary and partner of the hospital, we ensure that we are both fiscally responsible and compliant in the identification and allocation of costs by research within the facility.
It is the Principal Investigator's responsibility to fill out the HHS Resource Utilization Checklist (HRUC) and submit it along with their application to the IRB. The IRB passes it along to the HHS Compliance Office for review. The HRUC is the beginning of the process to create a Study Administrative Record in EPIC to which service may be charged for the study. As such, additional training in EPIC procedures is required for researchers obtaining hospital services. Information about that training will be provided after initial review of the HRUC is complete.
HHS research pricing for patient care procedures provided to HHRI projects is based on reimbursement rates set by CMS/Medicare. For specific pricing rates, either email the Research IT Specialist at firstname.lastname@example.org or review the CMS pricing tools detailed below.
Research Pricing can be separated into three components: 1) professional bills (PB) to represent the cost of a provider’s time, 2) hospital bills (HB) to capture the facilities costs needed to complete a procedure, and 3) research pharmacy fees.
PB costs are determined by the CMS Physician Fee Schedule. This website is designed to provide information on services covered by the Medicare Physician Fee Schedule (MPFS). The Physician Fee Schedule look-up tool will take you through the selection steps and provide pricing for specific procedure codes. If you have questions on which codes to use please contact the Research IT Specialist at email@example.com.
HB rates are determined by using a combination of the Minnesota rates in the Clinical Laboratory Fee Schedule and the HHS-specific rates in the Addendum B fee schedule. The Clinical Laboratory Fee Schedule is available for download and rates from Addendum B are available upon request. Please contact the Research IT Specialist at firstname.lastname@example.org for questions about HB fees.
In addition to standard dispensing fees per dose of a medication, research pharmacy fees at HHS also include the actual amount of time it requires the research pharmacy staff to set up and manage a study. The Research Pharmacy Pricing Worksheet will aid in determining costs for the proposed pharmacy work to be completed.
Fee for Research Order Set Builds
HHS clinical researchers with complex and long-term protocols may request assistance from the HHS Electronic Health Record (EHR) team to create order sets. Pricing for this support is similar to the pricing process for the research pharmacy in that time spent building order sets for research is billed to the study. The HRUC is a helpful document in assisting the EHR team to understand a protocol so they can provide realistic time estimates for the build. If a research order set build is being contemplated for a new study, please contact the Research IT Specialist at email@example.com.
The below links are additional resources for researchers conducting clinical research.