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

01/07/2020 Updates and New Requirements for CITI Training

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

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

Consulting

  • Working with staff on a variety of clinical research issues including protocol development and management, research ethics, study cost analysis, and budget development
  • Research staff management coaching
  • Consult with staff to identify general and study-specific obligations for successfully carrying out a research project
  • Facilitate preparation for federal, sponsor, or internal audits
  • Assist with electronic literature searches, manuscript preparation, IND/IDE application preparations
  • Act as a liaison for external sponsors

Quality Assurance

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

Resources

  • Maintain investigative and non-investigative ListServs for exploring and resolving research questions or impediments and dissemination of information relevant to global, national, and local clinic research
  • Maintain a lending library of research books, articles, and electronic information

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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