Medical College of Georgia - Research - Office of Human Research Protection

CITI - Collaborative Institutional Training Initiative

The Collaborative Institutional Training Initiative (CITI) was founded in March 2000 to develop a web based training program in human research subjects protections. It has grown to include several hundred participating institutions from around the world.

Your selection of the learner group should be based on research that you are conducting or plan to conduct.  For example, if you are currently conducting non-FDA regulated studies and plan to conduct FDA regulated studies, then please select Learner Group 1 FDA Regulated Research.

*For any questions regarding CITI, please contact Kim Koss at (706)721-1481 or email at kkoss@mcg.edu.

Getting Started - Initial Certification/Registration


CITI certification is required for all investigators and research team members who have protocols conducted at MCG, MCGHI, and the VAMC regardless of the source or type of funding.

STEP 1-Read this webpage regarding CITI
STEP 2-Identify your learner group (see desription table below))
STEP 3-Register for CITI at www.citiprogram.org
STEP 4-Successfully and fully complete the learner group
STEP 5-Print the certificate for your records
STEP 6-Use the electronic calendar to set up a reminder

Tips: 

Please note that you should only select one learner group from our web site, once you

register. If you select more than one module, it will require your completion of all the modules that you select. If you select the incorrect learn group associated with your research area, you will be asked to re-enter CITI and complete the appropriate learner group.

For each module, you must score 80 or above.  This is not an overall average, but every module.  If you don't score 80 or above, you can immediately re-take the module test, and continue taking the test until your score improves. 

Set aside a few hours at a time to complete CITI from start to finish.  Or, you may work on CITI at intervals, over the course of several days.

*There are certain exemptions from CITI, see * at the bottom of this page

Group Name

Description

Group 1

FDA Regulated Research: (15 modules)

  • Investigational drugs, devices and biologics

Similar to Tiers 4 and 4a from "Concepts in Concepts in Clinical Research"

Group 2

Non-FDA Regulated Research: (14 modules)

  • Prevention/Intervention Studies
  • Community-Based Studies
  • Investigator-Initiated Studies that do not involve investigational drugs, devices or biologics

Similar to Tier 3 from "Concepts in Concepts in Clinical Research"

Group 3

Human Derived Materials Research: ( 10 modules)

  • Human-Derived Materials Research Specimens
  • Human Tissue
  • Genetic/Reproductive Material
  • Medical Records, Databanks and Registries

Similar to Tier 2 from "Concepts in Concepts in Clinical Research"

Group 6

VA Research : (15 modules)

  • For researchers who conduct any of their studies at the VA.  Augusta VA researchers may use this as their annual training.

 

Group 7

Social/Behavioral Research : (13 modules)

  • Surveys
  • Questionnaires
  • Interviews
  • Photography
  • Tape Recordings

 

                                                                                                   

Please do not select the following groups unless you are a member of the Human Assurance Committee (HAC) or staff within the Office of Human Research Protection (OHRP) office:

Group 4

Office of Human Research Protections Staff ONLY (23 modules)

 

Group 5

Human Assurance Committee Members ONLY (20 modules)

 

 

 

Please do not select the following groups unless you are required to take these as part of your graduate training or as the result of an OHRP audit finding:

Group 8

Research Ethics - grad students (8 modules )

 

GCP

Good Clinical Practice (15 modules)

 

 

The IRB Reference modules (2 required and 38 electives) are open to everyone.

Recertification
Recertification is required every 3 years after initial certification for MCG & MCGHI research team members, VA research team members must recertify every year.  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. 

Learner Groups
There are several Learner Groups available for our institution.  However, select only the one group that best suits the current planned research level.   If you need assistance choosing the Learner Group that best suits your research area, please contact Kim Koss ext-1481
 

NOTES:  Do not reset the grade book, as this will archive your completion record and delete the grade book.  If you are required to take other modules for future research and have reset the grade book, you will be required to complete the entire Learner Group again.   You will be able to retrieve the completion report at any time in the future as evidence of course completion.

 

CITI International Research Course Site
CITI has opened the new CITI International Research Course Site at www.irbtraining.org. This site offers Chinese and Spanish translations of CITI modules on history, ethical principles, US regulations and informed consent issues. This site may be helpful for research studies that include foreign collaborators whose institutions do not have a required research education program. For more information, visit the CITI site www.citiprogram.org.

The International Course does not replace the MCG requirement that all research team members must complete CITI before they can begin working on a study.

If you are interested in providing the international course to international collaborators, please contact Kim Koss ext-1481.

 

*Exemptions from completing the CITI program:

  • Certified Clinical Research Coordinators through the Association of Clinical Research Professionals (ACRP)
  • Society of Clinical Research Associates (SOCRA)

Current certification must be submitted to OHRP to meet this exemption.

 

Revised 8/20/07, 1/7/2008, 2/29/2008, 7/30/08