Office for Education & Quality in Clinical Research
The Hennepin Healthcare Research Institute established the Office for Education & Quality in Clinical Research (EQ) in October of 2002. Its purpose is to provide a centralized office for the guidance and facilitation of the clinical research process. All HHRI and HHS clinical researchers and their staff are welcomed and encouraged to use the resources the EQ provides. There is no charge, as HHRI continues to honor its commitment to ethical research practices and the protection of our research participants.
The provided services of the EQ are multifaceted and can vary with the specific request of the investigator or staff. See more about services below.
Office for Education and Quality in Clinical Research (EQ) Staff
Bonnie Crissman – Director
Deb Grillo – Manager
Chris Waller – Clinical Research Administrator II
Contact
To contact Office for Education & Quality in Clinical Research (EQ) staff, please email EQ@hhrinstitute.org
OEQCR Standard Operating Procedures (SOPs)
OEQCR administrative and compliance SOPs are maintained by the Office for Education and Quality in Clinical Research (EQ). Guidance is provided as part of HHRI's commitment to ethical research practices and the protection of our research participants.
Recorded EQ Forums
| Date | Title | Link |
| June 2026 | Sponsor-Investigator Practical Application: Independent Study Monitoring | https://youtu.be/CJl3F6dvRWc |
| October 2024 | Research and Evaluation Data Analytics Core (REDAC): What is REDAC and how can it help with my research? | https://youtu.be/H9yGC-90iFo |
| May 2023 | The what, why and how of single IRB (sIRB) and working with Advarra | https://youtu.be/wl1lvP_zRLM |
| April 2023 | Emergency Preparedness and Human Research | https://youtu.be/4ELdL3mKlc0 |
| February 2023 | Cayuse Tips and Tricks and EQ Training Requirements | https://youtu.be/9_zHjtsCNlQ |
| December 2022 | Incident reporting: promptly reportable information and submitting incidents in Cayuse HE | https://youtu.be/9diKB2z8sWc |
| September 2022 | Investigational Drug Studies | https://youtu.be/0AUfrR39Z2M |
Clinical Research Guidance - 501 MANUAL Conducting Human Research
The Clinical Research Guidance provided in the 501 MANUAL Conducting Human Research is implemented and maintained by the Office for Education and Quality in Clinical Research (EQ) and the Human Research Protection Office (HRPO). Guidance is provided as part of HHRI's commitment to ethical research practices and the protection of our research participants.
Services
The provided services of the EQ are multifaceted and can vary with the specific request of the investigator or staff. Examples of provided services are listed below.
Introductory Training for New Research Staff
CITI online training for investigators and other research staff
Consent Competency (in person/virtual): an introductory training for research staff that provides the forum for practicing the requirements and recommendations for connecting and informing participants about a study.
Hazardous Materials Shipping (Hazmat) and Bloodborne Pathogen training: Hazmat has an online and in-person component to ensure understanding of federal requirements for shipping hazardous material; Bloodborne Pathogen training is an online course with some in-person follow-up
Phlebotomy Competency: Annual requirement for any research staff conducting research blood draws. Exception: HHS employee who conducts blood draws as a job task in the HHS role.
Mentorship
EQ provides specific hands on training for new to HHRI/research staff who are in need of specific job task training, and/or help acclimating to HHS/HHRI systems. These staff may be providing sole study support or are part of a smaller group that is supporting several studies.
Study Start-up Program
The intention of this program is for the Office for Education and Quality in Clinical Research (OEQCR) to collaborate with the Human Research Protection Office (HRPO) to ensure that IRB-approved research involving human subjects has a study plan that meets regulatory and institutional standards and that study staff have the tools and resources necessary to implement the plan. See OEQCR Standard Operating Procedures - 21 Study Start-up Program for more information.
Post-Approval Audits
As part of AAHRPP accreditation and HHRI’s commitment to the safety of its research participants, EQ conducts annual routine post-approval audits. EQ also conducts audits at the request of the IRB or Institutional Official. See OEQCR Standard Operating Procedures - 20 Compliance Activities for more information.
Post-Approval Internal Monitoring Program
OEQCR has a monitoring program that is designed specifically for a Sponsor-Investigator who does not have access to an external monitor and needs to meet regulatory requirements by engaging an internal monitor. See OEQCR Standard Operating Procedures - 24 Post-Approval Internal Monitoring Program for more information.
Other EQ Supported Services:
ClinicalTrials.gov: Guidance for PI/study team who are responsible for managing the requirements of the CT.gov clinical trial record.
External monitor management: In collaboration with HR, EQ works with study coordinators to secure on-campus and remote monitor access to study records and source documentation.
Association for the Accreditation of Human Research Protection Program (AAHRPP) Accreditation: EQ in collaboration with HRPO strives to ensure the Human Research Protection Program (HRPP) continues to provide the highest level of protection for human research participants through AAHRPP accreditation.
