Getting Started - Initial Certification/Registration CITI certification is required for all investigators and research team members who have protocols conducted at GRU, GRU Medical Center, 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 description 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 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.

To pass CITI and obtain certification, you must have an overall score of 80 or above. If you do not pass initially, you can immediately re-take the module tests, and continue taking the tests

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

Group 1 FDA Regulated Research: (15 modules)

Description

 Investigational drugs, devices and biologics seeking FDA approval 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 Group 3 Human Derived Materials Research: ( 10 modules)

 Human-Derived Materials Research Specimens  Human Tissue

 Genetic/Reproductive Material

 Medical Records, Databanks and Registries 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 Institutional Review Boards (IRBs) 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

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 GRU & GRU Health research team members, VA research team members must recertify every 2 years. 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.

*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. Learner Groups

There are several Learner Groups available for our institution. However, select only the one modules ) 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 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 GRU 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 ext-1481.