Skip to main content

IRB Education & Training

In order to ensure the safety, confidentiality, and welfare of human subjects involved in research, the University requires and encourages specific and optional training and continued education programs.

Human Subjects Protection - CITI

All investigators and study team members who participate in the design, conduct, or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. The university uses the Collaborative Institutional Training Initiative (CITI) web-based human research course to satisfy the requirement for researchers at MUSC for training in human research subjects protection. Initial and continuing education (every 3 years) are required as explained below.  Training should be completed prior to submitting initial research proposals, continuing reviews, or amendments changing study personnel to the IRB for review and approval. 

MUSC CITI Training Requirements for Human Subjects Research

The CITI training you will need to complete for MUSC are as follows:

1) Human Subjects

  • Group 1. Biomedical Investigators and Key Personnel

OR

  • Group 2. Social/Behavioral Investigators and Key Personnel

AND

2) Good Clinical Practice (GCP)

  • GCP for Clinical Trials with Investigational Drugs and Biologics (Biomedical ICH Focus)

OR

  • GCP – Social and Behavioral Research Best Practices for Clinical Research

OR

  • GCP for Clinical Investigators for Devices

You must complete one of the listed courses from both the Human Subjects and Good Clinical Practice trainings. Choose the track (biomedical or social/behavioral) that best fits your research. The Basic Course has to be taken before the Refresher Course will be accepted. Once the Basic Course is completed, the Refresher Course will need to be taken every 3 years. You should get an email reminder from CITI when your trainings are due to expire.

New MUSC Users

The Basic Human Subjects Course is required for investigators and study team members who have not previously completed the MUSC CITI course. There are two educational tracks for the basic course: Biomedical or Social and Behavioral. To receive maximum benefit, you should choose the track most closely matching the research in which you are involved. The Basic Biomedical and Social/Behavioral Courses have 17 and 16 modules, respectively.  A minimum aggregate score of 75 percent is required to pass the Human Subjects Course. 

The Basic Good Clinical Practice (GCP) Course is required for investigators and study team members who have not previously completed the MUSC CITI course.  There are two educational tracks for the basic course: Biomedical or Social and Behavioral. To receive maximum benefit, you should choose the track most closely matching the research in which you are involved. The Basic Biomedical and Social/Behavioral Courses have 13 and 9 modules, respectively.  A minimum aggregate score of 80 percent is required to pass the GCP Course. 

Each module may take 10 to 30 minutes to complete and most contain a quiz. The modules do not have to be completed in a single login session.

Note:  If you have not previously completed the Basic Human Research Course or the Basic GCP Course, taking the Refresher Human Research Course and the Refresher GCP course will not satisfy the training requirement. 

See additional information below regarding Faculty/Staff Transferring from Another Institution to MUSC.

How to add courses:

Guidance for New MUSC Users

Returning MUSC Users

The Refresher Human Research Course is required for investigators and study team members every three years as continuing education in human subjects protections. There are two educational tracks for the Refresher Course: Biomedical and Social and Behavioral. In order to receive maximal benefit, you should choose the track most closely matching the research in which you are involved. The Refresher Biomedical and Social/Behavioral Courses have 10 and 12 modules, respectively.  A minimum aggregate score of 75 percent is required to pass the Human Subjects Refresher Course. 

The Refresher Good Clinical Practice (GCP) Course is required for investigators and study team members every three years as continuing education in human subjects protections.  There are two educational tracks for the basic course: Biomedical and Social and Behavioral. In order to receive maximal benefit, you should choose the track most closely matching the research in which you are involved. The Refresher Biomedical and Social/Behavioral Courses have 7 and 8 modules, respectively.  A minimum aggregate score of 80 percent is required to pass the GCP Refresher Course. 

Each module may take from 10 to 15 minutes to complete and most contain a short quiz.  The modules do not have to be completed in a single login session.

 Note: If you have not previously completed the Basic Human Research Course or the Basic GCP Course, taking the Refresher Course and the Refresher GCP course will not satisfy the training requirement.

If you have taken the Basic Course for the Human Research Course prior to 2009 and are now being prompted by CITI to retake it, please see Frequently Asked Question #9 below for further information.

See additional information below regarding Faculty/Staff Transferring from Another Institution to MUSC.

How to add courses:

Guidance for Returning Users

Faculty/Staff Transferring from Another Institution to MUSC

While some researchers may have taken CITI modules at a previous institution, MUSC requires that anyone transferring to MUSC must complete the MUSC Basic Biomedical or Social and Behavioral modules and Good Clinical Practice modules prior to beginning research activities (even if the course was completed at a previous institution).

Questions or Assistance:

citi@musc.edu

The IRB offers an Education Outreach Program which provides IRB education in a Basic and/or Advanced IRB Training format to the MUSC research community.  The Basic IRB Training format provides a broad overview of the IRB functions, IRB review types, and common pitfalls encountered with the application process.  The Advanced IRB Training offers more in-depth trainings regarding submitting Initial Studies, sIRB and Reliance Studies, Amendments, Continuing Reviews and Status Updates, and Reportable Events in the eIRB system.  For more information, or to request trainings, please email the IRB Education Administrator.

The IRB sends out an IRB Quarterly Newsletter which provides IRB updates, policy highlights, and tips for IRB submissions. View previous IRB Newsletters and subscribe for future updates. 

The Support Center for Clinical & Translational Science (SUCCESS) is the consolidated entry point for access to research expertise, information, and navigation spanning the entire research spectrum, from inception through technology transfer and dissemination of best practice models.  The SUCCESS Center provides consultations with the study application submission process.

The purpose of the Core Clinical Research Training (CCRT) is to prepare research personnel to coordinate cost-effective health care research which protects the rights and safety of human subjects, achieves recruitment and retention outcomes and contributes to the science of health care. Individuals completing the training will be prepared to coordinate research studies in compliance with the Good Clinical Practices and federal regulations concerning human subjects research.

The Clinical Trials Bootcamp is targeted at clinically-focused faculty and post-docs who are interested in participating as an MUSC PI in a multi-site study or who need additional support or a refresher on elements of conducting a clinical trial.  The bootcamp will provide a high-level overview of site PI responsibilities for multi-center studies.

The Integrated Departmental Education for Administrators (IDEA) program is a comprehensive initiative developed to meet the research administration needs of our campus to increase their effectiveness and streamline the administrative process related to research administration.The goals of this program are to:

  • Help ensure compliance to state, federal, and university policies and procedures.
  • Provide staff with training (and tools) for their role in grant administration.
  • Improve research administration service to faculty.

eIRB Training & Guidance

Login instructions, guides for new users, FAQs, and information about continuing reviews, annual status updates, and reportable events.

eiRB Training Guidance

Frequently Asked Questions – CITI

It is recommended to only have one CITI Program account to keep accurate completion records and to avoid duplicating previously completed coursework. CITI is unable to delete accounts but if you would like to merge multiple accounts, please send an email to support@citiprogram.org and include the following information: (1) Your first and last name, (2) the name of your institution, (3) the username or member ID for the account to keep, and (4) the username(s) or member ID(s) for the account(s) to merge. For more information email CITI support at support@citiprogram.org or call 888.529.5929.

If research training records are not displayed for particular personnel check the following:

  • Make sure the personnel's first name, last name and email addresses are exact matches in eIRB and CITI.  Updates will appear for successful matches after system nightly data synchronization.
  • Required CITI training courses may not have been completed in affiliation with MUSC. The user should log into CITI to make sure the CITI profile has been associated to the MUSC and required training has been completed.  Updates will appear for successful matches after system nightly data synchronization
  • The personnel may have multiple eIRB and/or CITI accounts interfering with the matching process.  Contact your institutional eIRB administrator for assistance.
  • The personnel's eIRB profile may not be completed filled out to associate the user with an institutional department. Contact your institutional eIRB administrator for assistance.
  • For additional information, access troubleshooting and other resources in the Education and Training->Researchers and Staff->CITI Training Records section of eIRB, or otherwise contact your institutional eIRB administrator for assistance
  • Also, be sure to confirm that you are registered in the eIRB system if you are new to MUSC. 

While logged into CITI, under Institutional Courses, click “View Courses” next to the institution where courses were completed. Under the section titled “Learner Tools for Medical University of South Carolina” near the bottom of the webpage, click “View Previously Completed Coursework”. Find the course for the certificate you want to print. Under “Completion Record” click “View-Print-Share”. Next, choose if you want a Completion Report or Completion Certificate. Once decided, click “View/Print” to print the copy. You can email the link to someone if you choose “Copy Link”.

All investigators and study team members who participate in the design, conduct, or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. The University uses the Collaborative Institutional Training Initiative (CITI) web-based human research course to satisfy the requirement for MUSC researchers for training in human research subjects protection. Initial and continuing education (every 3 years) are required. Training must be completed prior to receiving initial or continuing IRB review of research proposals and approval for the addition of study personnel.

See MUSC CITI Training Requirements for Human Subjects Research section.

The Refresher Course is required for investigators and study team members every three years as continuing education in human subjects protection. Note: If you have not previously completed the Basic Human Subjects Course or the Basic GCP Course, taking the Refresher Human Subjects Course and Refresher GCP Course will not satisfy the training requirement.

A VPIN is the same as the NetID. That question in CITI can be bypassed by scrolling to the bottom of the page and clicking NEXT.

You, as an individual, have to choose the correct course.  See guidance for New MUSC User or Returning MUSC User.  Note:  The Basic Course version is to be completed first.  The Refresher Course version may not be substituted for the Basic Course.

See the following:

  • If the Basic Course was completed prior to 2009, it was part of the legacy data when CITI overhauled their system.  The IRB has a record documenting this completion and you should follow the instructions for adding the appropriate refresher course.
  • If the Basic Couse was completed after 2009, you may have more than one account or you may have completed the Basic Course at another institution and need to complete the MUSC version.
  • If neither of these apply, you may have completed a Refresher Course in error than the required Basic Course and you need to complete the Basic Course at this time.

CITI will assign you a course based on the information that you provide when answering during signing up for a course. If you indicate that you have completed a basic course, then it will assign the refresher course.

You can add the correct course to your CITI curriculum. To have a course removed you would need to email the MUSC CITI Administrator to request a course be removed.

No. See Faculty/Staff Transferring from Another Institution to MUSC section.

No. All personnel need to complete the institutionally required courses.

Contact Us

Office of Research Integrity

843-792-4148

1 South Park Circle
Building 1, Suite 401
Charleston, SC 29407