CITI - Frequently Asked Questions

Why Is the Web-Based Educational Program Required?

The Medical College of Georgia requires all individuals who have a formal affiliation with MCG (faculty including adjunct faculty, staff, students, or others with a formal affiliation with MCG) participating in research (investigators, coordinators, basic scientists, data managers, administrative personnel, or any one else involved in data collection, data management, or interactions with subjects or materials derived from subjects) involving human subjects or human derived materials to successfully complete the educational program CITI at the appropriate learning group prior to initiating any research activities. 

The MCG educational program is available to MCG-affiliated individuals only. Investigators affiliated with institutions other than MCG should complete the applicable human subject protection education and research training programs as required by their institutions; certificates of completion from such educational programs will be accepted by MCG for outside investigators.

How Is The CITI Program Individualized to my needs?

CITI consist of modules specified for each Learner Group that focus on a different aspect of bioethics and human subjects research.  The curriculum for each Learner Group was customized by our institution to meet the specific education needs of our researchers.

MCG CITI Learner Groups:

• FDA Regulated Studies:  Drugs, Devices and Biologics
• Human Derived Materials Studies: Medical records, specimens, genetics or reproductive materials, databanks, registries
• Non-FDA Regulated Studies: Investigator-initiated studies, prevention studies, community-based research
• Social and Behavioral Research: Surveys, questionnaires, interviews, photography, tape recordings
• VA Research: Required for researchers who conduct any of their studies at the VA
• Office of Human Research Protection (OHRP) Staff
• Human Assurance Committee (HAC) members
• Research Ethics
   

Who Completes Which Learner Groups of CITI?

Researchers will choose the Learner Group specific to their research area.  If a researcher conducts research involved in more than 1 Learner Group, they should contact Kim Koss, Training Coordinator, 1-1481 kkoss@mcg.edu for guidance.

If my Role or Responsibilities Change, Do I need To Complete Additional Sections?

There are instances when your research area may change and certification in your initial Learner Group is no longer sufficient.   For instance, a researcher initially conducted behavioral studies (i.e. completed the Social and Behavioral Research Learner Group) and later wishes to conduct FDA regulated studies.  Completion of additional modules are required before conducting FDA regulated research.

 If your research area changes, contact Kim Koss, Training Coordinator, 1-1481 kkoss@mcg.edu for guidance.

How Long Will It Take To Complete the Program CITI?

On average,  it will take about 4-6 hours to complete the “Basic Course”.   Users can complete the Course in as many sessions as needed.

Can I Be Approved To Do Research Before I Complete CITI?

No. Protocol approval or continuation of a current study will not be granted until all research staff members have completed CITI .

Can I Collect Data Or Review Medical Records Before I Complete CITI?

No. Data collection and medical record review is permissible until all IRB and/or OHRP requirements, including completion of the educational program, have been met. The study must be amended to add any new investigator(s) who may not participate in clinical research activities until formal written approval to do so has been granted by the IRB, which is not equivalent to completion of the educational program. 

In some circumstances, the addition of new sub-investigators may require full IRB review as outlined in the HAC policies: Protocol Amendments. Please refer to the website http://www.mcg.edu/research/OHRP/hac/polsect14.htm.

What Are The Recertification Requirements For CITI?

Recertification is required every 3 years after initial certification.  As of July 1, 2005 researchers must take the Basic Course for your Learner Group for recertification.  After this, you are only required to complete the “Refresher Course” for recertification. 

Are Continuing Education Credits (CEU) Available For CITI?

Yes.  CITI  provides links to apply for CME/CEU credits through the University of Miami CME office.

Contact Kim Koss, Training Coordinator at 721-1481 or kkoss@mcg.edu