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Office for Education & Quality in Clinical Research

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 subjects who consent to participate.

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.

 

Bonnie Crissman is the director of the Office for Education & Quality in Clinical Research.  She may be contacted at 612-873-5316 or bcrissman@hhrinstitute.org.

Policy & Procedure Updates

ATTENTION ALL HHRI EMPLOYEES:

As of June 10, 2020, all HHRI employees who are on campus and are performing phlebotomy procedures are required to complete annual safety/competency training and skills evaluation.
If an HHRI employee is not currently on campus, but will be performing phlebotomy procedures when they return to work, they will be required to complete the safety/competency training and skills evaluation before they return to performing phlebotomy procedures.
If you have already completed the safety/competency training and skills evaluation this year, the training is complete for 2020.
To schedule the training, please contact EQ:
Mary Berchem, mberchem@hhrinstitute.org
Deb Grillo, dgrillo@hhrinstitute.org
Bonnie Crissman, bcrissman@hhrinstitute.org
Any new employees with phlebotomy as part of their job tasks will be required to have completed a certified basic phlebotomy course previous to being hired by HHRI. Safety/competency training and skills evaluation will be a part of their onboarding required training. If a new hire does not have previous phlebotomy training and the hiring study or department wishes to pay for this training, it is at PI/department discretion to identify an appropriate course and pay for the employee to complete the course. The employee may not begin any phlebotomy activities until a certified course has been passed.
HHRI employees may not perform phlebotomy procedures without completing the annual safety/competency training and skills evaluation.
Please feel free to contact the EQ with any questions, we’ll be happy to help.

Updates and New Requirements for CITI Training

When logging into CITI to complete training requirements, please note these changes:

New Requirements

Annual HIPAA and Safety Training for Researchers is a course that has been added for all researchers and support staff

  • This course will be required to be completed annually

  • All researchers and research support staff are expected to complete this training in 2020

  • Effective immediately: the IRB may request personnel listed on a new or continuing review IRB application to complete the CITI HIPAA and Safety Training for Researchers module prior to granting IRB approval

  • For all personnel, this module must be completed prior to May 1st

Updates

  • All training is now added under the following researcher groups:

    • Biomedical Researcher

    • Social-Behavioral Researcher

    • Biomedical Researcher – Statistician

    • Administrative Staff

    • Human Subject Committee Member

    • IRB Chair/Vice-Chair

  • The “Primary Category” name has changed to “Biomedical Category.” This change is automatic and no additional action is needed.

ACTION REQUIREDWhen training is due, scroll down to the “Add a Course” link at the bottom of the list of your courses and add the group that best describes your role. This will ensure all required training is added and available for completion.

CITI training requirements based on researcher group:

Courses Required

Learner Category

Basic Category

(every 3 years)

HIPAA

(annually)

COI

(every 3 years)

GCP

(every 3 years)

IRB Chair/ Vice Chair

Biomedical Researcher

Biomedical Category

Yes

Yes

Yes

No

Social-Behavioral Researcher

Social-Behavioral Category

Yes

Yes

Yes

No

Biomedical Researcher

– Statistician*

Biomedical Category

Yes

Yes

No

No

Administrative Staff

Administrative Category

Yes

Yes

No

No

HSRC Member

HSRC Member Category

Yes

Yes

Yes

No

HSRC Chair/Vice Chair

HSRC Category

Yes

Yes

Yes

Yes

*A Biomedical Researcher – Statistician to be approved by the IRB on federally-funded research must choose the Biomedical Researcher group as they are required by federal regulation to complete the GCP course.

Contact the EQ with any questions or concerns:

Bonnie - bcrissman@hhrinstitute.org; Deb - dgrillo@hhrinstitute.org; Mary - mberchem@hhrinstitute.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.

Introductory Training for New Research Staff

CITI online training for investigators and other research staff

Intro to Research (in-person/virtual): primarily for the non-investigator research staff, but all are welcome

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  

This program is designed to provide support to investigator-initiated interventional/full committee studies.  Since the IRB requires study pre-review for these types of studies, the EQ works to identify these studies as early as proposal time to help provide feedback and support during the planning phase for study feasibility and implementation, as well as to work towards a quicker IRB review.

Monitoring

All FDA regulated studies require a monitoring component.  The IRB requires that a monitoring plan is addressed in IRB submission and the study protocol.  EQ offers support during the study development phase to provide feedback on the best monitoring approach depending on the risk level of the study.  EQ may provide fee-based monitoring support if monitoring requirements are identified through the IRB review process, or the study team requests EQ monitoring support.

Post-Approval Reviews

As a part of AAHRPP accreditation, EQ is required to conduct annual post-approval reviews.  EQ also conducts reviews at the request of the IRB or a Principal Investigator.  EQ uses a risk-based approach when identifying studies for annual reviews.  See EQ SOP 6.1 Post-Approval Reviews.  It can be helpful to request an internal EQ review when a study team is new to research, the level of risk for a study has increased, or it is known that an outside auditor will be reviewing a specific study.

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.

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