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California State University, Fresno has joined the Collaborative Institutional Training Initiative (CITI Program) to provide comprehensive research ethics education and training to all faculty, students, and administrators. Institutions around the world, including the top 20 in the U.S. News and World Report 2017 Best College Rankings and all of the academic medical centers in the U.S., rely on CITI Program for their research ethics, compliance, and professional development education needs.

Responsible Conduct of Research (RCR) training is viewed as an essential component of graduate education, and is also part of funding requirements of both the National Institutes of Health (NIH) and the National Science Foundation (NSF). Institutions rely on CITI Program to fulfill federal requirements for RCR, as well as Conflict of Interest (COI) training requirements outlined by Public Health Service (PHS) funding agencies.

CITI Login:  https://about.citiprogram.org/en/homepage/

Available Training:

Responsible Conduct of Research (RCR)

The National Institutes of Health (NIH), National Science Foundation (NSF), and U.S. Department of Agriculture (USDA) require certain categories of researchers to receive RCR training. RCR is increasingly viewed as an essential component of training, regardless of a researcher’s source of funding.

This course provides an in-depth review of the core RCR topics including authorship, collaborative research, conflicts of interest, human subjects, and research misconduct. Case studies and video examples are used to supplement key concepts. 

Language Availability: English, Portuguese, Russian, Spanish, Vietnamese

Suggested Audiences: Faculty, Postdoctoral Researchers, Principal Investigators, Staff, Students

Human Subjects Research (HSR)

Human Subjects Research (HSR) basic content is organized into two courses: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). They are intended for anyone involved in research studies with human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs). Additional modules of interest within HSR allow for exploration of several important topics and may be selected to meet organizational needs.  HSR also includes additional standalone courses for institutional/signatory officials, IRB chairs, and public health researchers.

Many authors in the field contributed to these courses and they have been peer-reviewed by experts.

Language Availability: English, French, Khmer, Korean, Portuguese, Russian, Spanish, Tamil, Vietnamese

Suggested Audiences: Researchers, Research Team Members, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Chairs, IRB Administrators and Staff, Human Subject Protection Staff, Students

Animal Care and Use (ACU)

The ACU courses are designed to meet U.S. Department of Agriculture (USDA) and Office of Laboratory Animal Welfare (OLAW) requirements for basic training in the humane care and use of animals.

The courses are intended to help investigators and Institutional Animal Care and Use Committee (IACUC) members work more productively. Additional courses are available for IACUC chairs, IACUC community members, and institutional officials (IOs), as well as individuals seeking training on post-procedure care and post-approval monitoring or wildlife research. Courses on working with specific animal types are also included.

These courses were written by multiple authors and peer-reviewed by experts.

Language Availability: English

Suggested Audiences: IACUC Members, Animal Workers and Staff, IACUC Chairs, IACUC Community Members, Institutional Officials, Investigators, Research Assistants, Students

Conflicts of Interest (COI)

The COI Basic course is designed to satisfy training requirements associated with the U.S. Public Health Service (PHS) regulations on financial conflicts of interest. There is also a COI Refresher course that offers retraining on key concepts and rules relating to these regulations. These courses are intended for investigators who receive funding from a PHS agency, including the National Institutes of Health (NIH), or who are required by their organization to be familiar with the PHS financial conflicts of interest regulations.

Organizations may want to customize these courses with institutional-specific details. Contact us to discuss organization-specific modules for the basic and refresher courses.

These courses were written by multiple authors and peer-reviewed by experts.

Language Availability: English

Suggested Audiences: Investigators Involved in PHS-Funded Research, Investigators Needing a Familiarity with PHS FCOI Regulations, Research Assistants

Information Privacy and Security (IPS)

Augmented penalties, audits, and required breach notifications under the Health Information Technology for Economic and Clinical Health (HITECH) Act's amendments to HIPAA have raised the stakes for healthcare organizations' compliance. IPS is designed to help ensure HIPAA compliance, quality assurance, and risk reduction.

IPS consists of three courses on Health Privacy (focusing on HIPAA), Information Security, and the Family Educational Rights and Privacy Act (FERPA), which can be utilized based on organizational needs. Each course includes content for individuals who only need basic information, as well as content tailored to specific roles, applications, devices, and settings. It is suitable for anyone who works with individually identifiable health data (HIPAA-defined "PHI"), or FERPA-covered educational records and data, or has responsibilities for setting policies and procedures with respect to these types data.

The Health Privacy and Information Security courses were authored by Reid Cushman, PhD, of CITI Program and peer-reviewed by experts.

The Family Education Rights and Privacy Act (FERPA) course was authored by Thomas W. Gold, PhD, of Network for Teaching Entrepreneurship and peer-reviewed by experts.

Language Availability: English, Korean

Suggested Audiences: Teachers, Educators, IRB Administrators, Administrators, IRB Members, Individuals Working with Identifiable Health Data (HIPAA-defined “PHI”), Researchers, Instructors, Students

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) includes four basic courses tailored to the different types of clinical research. Three of the courses also include corresponding refresher courses. CITI Program offers several GCP courses that are acceptable GCP training for the new NIH policy released on 16 September 2016.

The following GCP ICH E6 Investigator Site Training courses also meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors and have been updated to include the ICH E6(R2) Addendum:

Basic Courses - English with ICH E6(R2) updates, Spanish, and Portuguese

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

Refresher Courses - English with updates to include ICH E6(R2), Spanish, and Portuguese

  • GCP FDA Refresher
  • GCP ICH Refresher

GCP courses were written by multiple authors and peer-reviewed by experts.

Language Availability: English, French, Korean, Portuguese, Spanish, Thai, Vietnamese

Suggested Audiences: IRB Members, Clinical Research Coordinators, Clinical Research Organizations (CROs), Researchers, Investigators, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Sponsors, Study Coordinators

 

Training Resources:
CITI Program Registration Procedure (PDF)    (VIDEO)
CITI Program RCR Instructions (PDF)