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 firstname.lastname@example.org 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)
HHS Clinical Services for Research
Medical Research is an important priority for HHS, and as a subsidiary and partner of the hospital, we need to make sure 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 HCMC Resource Utilization & Coverage Analysis Checklist - Appendix A (HRUC) and submit it along with their application to the IRB. The IRB passes it along to the HCMC Compliance Office for review. The HRUC is the beginning of the process to create a record in EPIC to whic service may be charged to the study. As such, additional training in EPIC procedures is required for researchers obtaining hospital services. Information about that training will be provided after review of the Checklist is complete.
HHS research pricing for patient care procedures provided to HHRI projects is based on reimbursement rates set by CMS/Medicare. To assist investigators in more easily identifying frequently used procedures, HCMC Revenue Integrity has developed a Medicare research fee schedule that contains all currently active procedure codes used for research. The currently active codes and pricing is available here: [HCMC 2017 Research Fee Schedule]. As new procedures are requested for research, they are added to this pricing list. If you are uncertain of which procedure codes are applicable to your study or it will use codes not currently on the pricing list, additional help can be found here.
The below links are additional resources for researchers conducting clinical research.