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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 (OEQCR) 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 OEQCR 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 OEQCR are multifaceted and can vary with the specific request of the investigator or staff.  Examples of provided services include:

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.

Association for the Accreditation of Human Research Protection Programs (AAHRPP)

  • Administration of ongoing AAHRPP accreditation

Training

  • Training for newly hired staff
  • Continuing education for established staff
  • Certification (ACRP and SoCRA) preparation classes
  • Guest speakers for continuing education in the research process

Quality Assurance

  • Responsible for Post HSRC Approval Quality Assurance Reviews
  • Responsible for HSRC requested discretionary audits

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.

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