Office of Research Required Education - Office of Research

Required Education

 

Click for a list of all UC Davis CITI certified researchers

 

In This Section 

 

Required Training

Investigators and staff engaged in human subjects research may complete any one of the following to meet the basic human research protections training requirement:

    • CITI Basic course for Biomedical Researchers and staff; or
    • CITI Basic course for Social and Behavioral Researchers and staff

CITI offers two human subject research protection courses, one for researchers conducting biomedical research and one for researchers conducting social and behavioral research. You should choose the course that applies to the majority of your research.

Investigators and staff engaged in a clinical investigation or an NIH-funded clinical trial are required to take Good Clinical Practice (GCP) training in addition to basic human research protections training.

 

Investigators and staff engaged in a clinical investigation or an NIH-funded clinical trial are required to take GCP training in addition to basic human research protections training.

If the research is a clinical investigation under FDA jurisdiction you must complete one of the following:

    • CITI GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus); or
    • CITI GCP for Clinical Trials with Investigational Medical Devices.

If your research involves both investigational drugs and devices, select the training that applies to the majority of your research.

If the research is an NIH-funded clinical trial not subject to FDA jurisdiction you may complete the one of CITI training listed above or either of the following:

    • CITI GCP – Social and Behavioral Research Best Practices for Clinical Research; or
    • NIH Good Clinical Practice  Offered through the UC Davis Learning Management System, this training focuses on GCP for social and behavioral clinical trials. Once you log into LMS search “NIH” to locate the course.

If you are involved in the conduct of an NIH-funded clinical trial, you are required to be trained in GCP.  If you fail to maintain the training, you may lose funding.

Updating Training in IRBNet:   If training is completed through NIH, you must upload a copy of the certificate to the Designer page with every submission.

 

CIRTification human research protection training can be completed to satisfy the training requirement when the following conditions are satisfied:

    • The researchers are not affiliated with a domestic institution, including UC Davis;
    • The research involves only minimal risk;
    • The training is conducted by a facilitator experienced in human research protections who has completed the basic CITI course for investigators and has current CITI certification or is otherwise approved by IRB;
    • The facilitator and research personnel receiving training attend the entire training session and sign the CIRTification Completion Log;
    • The facilitator signs the attestation on the CIRTification Completion Log; and
    • The PI maintains a copy of the CIRTification Completion Log.

Click here to download the CIRTification training slides.

The NIH Program Protecting Human Research Participants course is no longer being offered by the NIH. Previous completion of the course may satisfy the  training requirements for Minimal Risk Human Subject research.

Updating Training in IRBNet:   If training was completed through NIH, you must upload a copy of the certificate to the Designer page with every submission.

An external investigator submitting to UC Davis IRB for review under a reliance agreement may complete one of the following to meet the basic human research protections training requirement:

  • The human subjects protection training required by the investigator’s home institution.
  • UCD CITI human subjects protection training. External investigators may register with CITI, affiliate with UC Davis, and select the appropriate training course. Additional information about the accepted training courses can be found under the “Basic Human Research Training” and “Good Clinical Practice” tabs on this page.
Training is valid for a three-year period. Investigators and staff must renew their training certification before it expires by taking either a refresher course or retaking the full course. Members of the research team who have not completed human subject research protection training may not take part in aspects of the research that involve human subjects or their private identifiable data.

 

Who Must Complete Training?

Investigators, staff, and faculty advisors are required to complete human subject research protection training prior to engaging in research activities. Training should be completed before submitting an application for IRB review when initiating a new study, or prior to engaging in research activities, including access and analysis of private identifiable data, when joining an active research project. It is the responsibility of the Principal Investigator to ensure all research staff have completed all necessary training before engaging in research activities. The following personnel engaged in research must complete training:

 

 

Creating a CITI Account

CITI Guide to Getting Started

  1. Go to citiprogram.org.
  2. At the top, right side of the screen locate and click “Register”
  3. In the search bar enter “University of California, Davis” and click the check box to indicate that you agree to the terms of service. Click “Continue to Step 2.”
  4. Enter your personal information and click “Continue to Step 3.”
  5. Enter a Username and Password and click “Continue to Step 4.”
  6. Enter your country of residence and click “Continue to Step 5.”
  7. Answer the required questions and click “Continue to Step 6.”
  8. Provide the required information and click “Continue to Step 7.”
  9. Use the radio buttons to select the appropriate learner courses and click “Complete Registration.”
  10. Click “Finalize Registration.”

 

Linking CITI Credentials in IRBNet

Instructions for linking your CITI credentials to your IRBNet Account can be found here.

 

Verifying Training Status

The CITI Training Report only contains UCD research personnel who have completed training through the CITI website (initial or refresher course) within the last 3 years. Training completed elsewhere (NIH, CITI training through another institution) is not listed. Email hs-irbeducation@ucdavis.edu or contact the IRB Education group with questions.

 

Adding UCD Affiliation & Transferring Completions

 

If you have completed CITI training at another institution, you will need to affiliate your CITI account with UCD.  Do not remove affiliation with your previous institution.  After you have affiliated with UCD, transfer any modules that are shared between UCD and your former institution.  CITI will ask you to complete any modules required by UCD that were not required by your previous institution and/or modules that are no longer eligible to be transferred.

Review CITI’s guidance: How to add/change your affiliated institution or transfer completions for detailed instructions.

Note: The IRB at UC Davis does not have access to view certifications from other institutions/sites, nor add certifications from other institutions/sites to the “Verified CITI Training” report. PI’s and Co-PI’s relying on certifications from other institutions/sites are requiredto submit their CITI certificates with the initial review application and at every continuing review.

 

CITI Training From Other Institutions/Sites

What about VA investigators who have taken the VA’s required CITI training course? 

The VA requires regular training for all individuals engaged in research with human subjects, their tissue or data. If you are working at the VA, we recommend completion of the VA CITI training, which will meet UCD’s requirements.

Please remember there are other annual education requirements for the VA, so please check the VA training page to ensure you and all members of your research team are current with those requirements. Contact the VA directly with questions about these requirements.

Note: The IRB at UC Davis does not have access to view certifications from other institutions/sites, nor add certifications from other institutions/sites to the “Verified CITI Training” report. PI’s and Co-PI’s relying on certifications from other institutions/sites are requiredto submit their CITI certificates with the initial review application and at every continuing review.

Do collaborators at other sites need to complete UCD’s training? 
Collaborators only need to complete this training if UCD has agreed to act as their IRB of record. If outside collaborators have received their own IRB approval, they do not need to complete the UCD training and should defer to their own IRB’s educational requirements.[/symple_toggle]

 

Merging Duplicate CITI Accounts

If you have made multiple UCD CITI accounts, they should be merged before your CITI account is linked to IRBNet. Please contact CITI Program at citisupport@med.miami.edu for assistance.