The Collaborative Institutional Training Initiative (CITI) Program is a leading provider of research education content. Its web-based training materials serve millions of learners at academic institutions, government agencies, and commercial organizations in the U.S. and around the world. Phronetik has chosen to subscribe to the CITI Program for multiple research training requirements, including for human subjects research.

All Phronetik Key Personnel involved with human subjects research must have a current and complete Phronetik Human Subjects Research certification or Phronetik Good Clinical Practice (GCP) certification via CITI prior to inclusion in the IRB application (either via initial submission, amendment, or through use of the "edit study personnel" function):

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• a new study on which they are named

• an amendment application adding them to a previously approved study

• a continuing review application for a study on which they are named

The webIRB system will conduct automatic checks to ensure all key personnel have current human subjects training. If any key personnel have missing or expired training, or if the personnel’s CITI account is not linked to their Phronetik Single Sign On (SSO), the system will block submission of the application.

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• Please view the applicable guidance document below for details about how to link your existing CITI account or how to create a new linked account:

  • Create a New CITI Program Account via Phronetik SSO

  • Link an Existing CITI Program Account via Phronetik SSO

• For more information on the automatic webIRB function, please refer to the webIRB video tutorial.

Principal Investigators are responsible for assuring that all Key Personnel on the study have completed the Phronetik CITI training requirements.

• Key personnel on any study may choose to complete GCP training in lieu of human subjects research training.

• Key personnel on NIH- funded clinical trials must complete GCP certification (either in addition to or instead of Human Subjects Research certification).

If Phronetik is relying on another institution’s IRB to review your study, then Phronetik is usually required to certify to that IRB that all Phronetik Key Personnel have completed Phronetik’s CITI requirements.

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If Phronetik is the reviewing IRB for your collaborating sites, then those sites are usually required to certify to Phronetik that their Key Personnel have met those sites’ own training requirements.

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CITI training completed at another institution may or may not transfer for credit at Phronetik, depending on how recently it was completed, and the type of course(s) completed at the other institution. To determine if previously completed coursework in CITI will transfer, affiliate with Phronetik in your existing CITI account, link your existing account to your Phronetik single sign on (SSO), then follow the prompts to “Add a course”.

At the end of that course selection process, any modules recently completed for another institution that overlap with the Phronetik CITI course(s) enrolled will automatically be credited to your Phronetik CITI course(s) (and will not have to be completed again).

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Key Personnel is defined as the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved with handling private information related to study participants during the course of a research project. Key Personnel also include Employee Sponsors who oversee student Principal Investigators in their conduct of human subjects research.

CITI HIPAA is required for all Phronetik researchers involved in research involving human participants that creates, uses, and/or discloses Protected Health Information (PHI). This includes research that involves the review of medical records or the creation of new medical records or the addition of information to existing medical records.

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There is no refresher course required for Phronetik HIPAA research training.

Anyone who is required to take our Phronetik CITI courses must first create an account within the CITI website or affiliate themselves with Phronetik if they already have an existing CITI account. All new CITI accounts must be created using your Phronetik single sign-on ID. 

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Please view the applicable guidance document below for details about how to link your existing CITI account or how to create a new linked account:

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• Create a New CITI Program Account via Phronetik SSO

• Link an Existing CITI Program Account via Phronetik SSO

Please note that linking your CITI account to your Phronetik single sign-on ID will not prevent access after leaving Phronetik.

Key Personnel must renew their Human Subjects Research or GCP training via CITI every 3 years. Depending upon the course selected to satisfy this requirement (GCP or HS), you will either complete the preselected refresher modules, or the 4 elective modules of your choice.

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You will receive an email notice from CITI 180 days, then 90 days, then 30 days prior to the expiration date for your course, but you may also log on to the CITI website to see when you are due to take your Refresher Course. You may complete the Refresher Course up to 180 days (that is, six months) prior to the expiration date of your current CITI training.

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• For those with existing Human Subjects (HS) certification, at the time of renewal, CITI will automatically enroll you in the HS refresher course. If you would prefer to complete GCP training instead of the HS refresher course, you may do so. Inside your Phronetik CITI account, click the "Add a course" button to add a GCP course and click the "Remove a course" button to remove the HS refresher course you no longer wish to take.