Courses

HIPAA Training: Information about HIPAA Training is provided by the Emory University Office of Compliance. The IRB does not monitor this training as part of its review. 

Emory University Covered Components: See Emory HIPAA Privacy Rule Policies for the latest list of Emory Components that are covered under HIPAA. For research data to be covered by HIPAA at Emory, the study needs to involve both treatment and electronic billing (unless the data is in the EHC medical record, in which case it is definitely covered by HIPAA). 

Individually Identifiable Health Information or Individually Identifiable Private Information: Health Information, including demographic information collected from an Individual that is: (a) created or received by a Health Care Provider, Health Plan, employer, or Health Care Clearinghouse; and (b) relates to the past, present, or future physical or mental health or condition of an Individual; the provision of Health Care to an Individual; or the past, present, or future payment for the provision of health care to an Individual; and (i) that identifies the Individual; or (ii) with respect to which there is a
reasonable basis to believe the information can be used to identify the Individual.

Sensitive Information: Sensitive Information is information regarding sexual attitudes, preferences or practices; information relating to the use of alcohol, drugs or other addictive products; information regarding an individual's psychological well-being or mental health; genetic information or tissue samples; or information that if released might be damaging to an individuals' financial standing, employability or reputation within the community or might lead to social stigmatization or discrimination.

Protected Health Information: Individually identifiable health information that is transmitted by electronic media or transmitted or maintained in any other form or medium.

De-identified: Information that has certain identifiers (view list of identifiers [PDF]) removed in accordance with 45 CFR 164.514 is no longer considered to be Protected Health Information. It is important to note that voice recordings are considered identifiers. If you plan to audio record interviews for transcription, even if you plan to destroy the source, these recordings are considered identifiable.

Training for Investigators and Research Staff Conducting Clinical Trials at Emory (NIH-funded and/or FDA-regulated)

Researchers doing NIH-funded clinical trials (as defined by the NIH) are required to complete a GCP-ICH course training every three years per NIH policy.

Emory also requires training modules for investigators on FDA-regulated clinical trials. These are to help them comply with the requirements of Good Clinical Practices, to properly delegate authority, to manage clinical trial operations, to recognize and avoid research misconduct, and to improve the outcomes of monitoring and audits performed by sponsors and the Food and Drug Administration.

For other research staff, there are required training modules that describe the regulatory requirements and best practices for their various responsibilities.

All required ethics and clinical research training must be complete before the IRB can approve a new study, or add new personnel to an ongoing study.

• Research staff performing coordinator functions* who have less than five years of experience must take an in-person 2-day course called "Introduction to Clinical Research." See the OCR website to learn how to sign up for this training.
• Research staff performing coordinator functions* with five or more years of experience and prior formal GCP-ICH course training can take the "Clinical Research Coordinator" Course in the CITI online system.
• Investigators* who started after June 1, 2016 must take a specific CITI GCP-ICH course ("Group 5") that contains three additional Emory-specific modules. 
  • Must be refreshed every three years while working on clinical trial(s).
• Additional information about training requirements per research role are covered in OCR's training requirements [PDF].

Registration for the online GCP course is done through CITI, just like the IRB-required courses. Please select the relevant course under "Add a course or update learners course", in your CITI account. 

For any additional questions about the clinical trials training requirement, please contact the Office of Clinical Research at OCR@emory.edu or 404-778-4960.

Note: eIRB now gets a data feed from CITI. Sometimes, records do not come over and we must ask you to upload completion certificates. See the CITI Training section for tips. 

If you have any questions, please contact irb@emory.edu.

Latest News

• Insight automatically verifies appropriate CITI training records for Emory research team members.
• This saves lots of time that IRB staff can use for other tasks, but only when it works.

Are your or a team member's CITI records not displaying in Insight or eIRB?  The person must update their Preferred Email in CITI and use SSO to log in.

See the end of this section for troubleshooting information!

Resources:

• Log into the CITI Training Program (Emory Login Required)
• Step-by-Step Guidance for Selecting Required Courses and Obtaining a CITI Account (PDF) (for Emory users with an Emory login and password)
• Step-by-Step Guidance for Obtaining a CITI account (PDF) (external collaborators engaged in Research reviewed by the Emory IRB. Note: find instructions to select courses in the guidance for Emory users)
• How to Associate an Existing CITI Account with the Emory CITI Account (PDF): for external collaborators associating their existing CITI accounts with Emory.
  • If you are a researcher who is new to Emory, please first login to your Emory CITI account using the SSO login option, and then follow this guide to add your external account to your Emory CITI account. That will ensure that our IRB staff can review your training in the eIRB system

NOTE: Do not put any sensitive data into CITI as your username (e.g. SSN) - all administrators will be able to see it.

Frequently Asked Questions

What is CITI?

The Collaborative IRB Training Initiative Program (CITI) is a leading online training program maintained by the University of Miami. It offers curricula in human subjects research, animal research, and the responsible conduct of research. If you are a first-time CITI user, you may wish to contact the IRB offices for help getting started.

Who has to take CITI?

All Emory personnel conducting "human subjects research" activities at Emory must take CITI.

• This includes anyone working with identifiable data or biological specimens for research purposes.
• This includes all roles: investigators, research nurses, coordinators, students, technicians, data collectors, and faculty advisors

Outside collaborators from other institutions (other than CHOA or VA) who have human research programs need only comply with their local training requirements. Emory IRB may ask for an attestation (as part of a reliance agreement) that the other institution has confirmed their training completion; or we may ask for the training certificates.

Outside collaborators who are independent, or are from institutions without human research programs, should take Emory CITI.

NOTE: Outside collaborators should click "Register" instead of "Log In Through Your Institution," and select Emory University as their affiliated institution. Avoid any buttons that say "SSO". They can enter garbage data for the Emory ID number.

Which CITI course do I have to take?

Emory and CHOA Researchers: Each institution tailors the CITI program to meet their own needs and expectations, so Emory personnel must take the Emory version of CITI.  Per Emory institutional training policy, CHOA study team members conducting FDA regulated or NIH funded clinical trials must affiliate with Emory and complete the additional modules within the Emory Biomedical and/or SHB course in addition to the CHOA GCP course. Note: CHOA personnel should upload their Emory Biomedical and/or SHB certificate and a copy of the CHOA GCP certificate when updating a study submission.

VA Researchers: The IRB will require the VA version, if a researcher is doing research at the VA. Emory will not accept a VA CITI for research done only at Emory.

Note: Please, do not confuse the Biomedical Course with the "Biomedical Responsible Conduct of Research" course. RCR is not required by the Emory IRB and will not count towards your training requirements.

For more information about what courses you need to take, please see Step-by-Step Guidance for Selecting Required Courses and Obtaining a CITI Account (PDF) for guidance.

Additional courses are available but are not required.

How long is my certification effective?

Three years.

What if it Expires?

The IRB staff cannot approve a new study or continuing review submission without CITI training for all study team members.

The IRB will not accept CITI certifications that expire after the date of study expiration. As a reminder, it is always the PI's responsibility to ensure compliance with institutional training requirements. 

For continuing review, you may submit a Modification to remove study members who are no longer part of the study, or who are unable to renew their CITI quickly enough (not possible for the PI or key Co-I's). The study team should maintain documentation of all required trainings throughout the year to prevent noncompliance.

Before submitting for continuing review, we recommend reviewing your research personnel list to ensure that 1) only current members are listed in the submission, and 2) to ask current study staff to refresh if needed.

What about GCP-ICH training refreshers?

GCP training is required every three years for NIH-funded clinical trials and for all FDA-regulated clinical trials including those that are not NIH funded. CITI Biomedical Refresher and CITI Group 5 GCP must be renewed every 3 years.

What if I have a CITI account through another institution, and want to certify for Emory (or vice-versa)?

Follow this guidance:

• How to Associate an Existing CITI Account with the Emory CITI Account (PDF): for external collaborators associating their existing CITI accounts with Emory.
  • If you are a researcher who is new to Emory, please first login to your Emory CITI account using the SSO login option, and then follow this guide to add your external account to your Emory CITI account. That will ensure that our IRB staff can review your training in the eIRB system
• Once you complete your profile questionnaire to select courses, the modules will automatically be listed as "complete" (if they match what you've previously taken), or "incomplete".
• To view your course completion history, follow the link to the CITI Course Completion Report.

What if I have inadvertently created two (or more) accounts in CITI? Which one should I use?

This can be an issue because when we check your CITI, we might check an out-of-date account and not notice that you are certified under a different account. It's best to have just one account of record.

Troubleshooting CITI "Not Certified" Issues in Insight

1. See if there are training records for the person (have the person check their profile, or use the "Training Lookup" function at the top of the Humans workspace).
   • If not, determine if the person is External vs internal (Emory) - they may be external with a Sponsored Account.
   • If an Emory employee/student, did they log into CITI via SSO? If not, Insight may not have been able to link their CITI records. If they have logged in via SSO, then skip to step 3.
   • If not Emory, do they need to do work in Insight? If not, add as external using our spreadsheet (External Study Team Member List template)
   • If the person does need to work in Insight, they will need sponsored account and their CITI training information will need to be added manually. This should generally be limited to CHOA or VA people. Please submit a request via our listserv to add training manually. 
2. Migrated studies: ensure a Migration amendment has at least been completed, if not submitted.
   • Make sure the first multiple-choice question on the Study Overview form is filled in accurately...
     • Do not check an Exempt category unless the study was Exempt in eIRB - exempt category studies all require Sociobehavioral CITI, while many have Biomedical instead
     • Note that chart reviews should not generally select the D4 category
   • Make sure people aren't listed with "Legacy role" as their role (those will always show as "Not Certified")
3. Do they have the right kind of CITI (Sociobehavioral? Biomedical? GCP?)
   1. Sociobehavioral is required for all studies where an Exempt category is checked on this question of the "Study Overview" form: "If your research is solely limited to any of the following activities, check the options that apply" (i.e. if any of D1 - D4 are checked)
   2. Biomedical or Sociobehavioral are acceptable for secondary data analysis studies
   3. GCP is required if: the study is an NIH funded clinical trial, or the study is FDA regulated (see Clinical Trials Registration form)
   4. Note: Roles of Data Coordinator/Manager and Statistician can take either module for any study
4. If the above fails, submit a ticket so we can review their training modules and troubleshoot more.

Rare situation: two people are in the system with same name and the study team chose the wrong one - so double check.

“Sponsor-Investigator” (S-I) refers to an Emory faculty member who holds the IND or IDE for a clinical investigation. This comes with many responsibilities, and thus a need for initial training.

First-time Sponsor-Investigators will be required to complete initial online training in Brainier.

Quick Steps for accessing the Brainier Learning Management System (LMS).

1. Go to the Human Resources page: https://hr.emory.edu/eu/index.html, and click LMS LOG IN
2. Enter your Network ID and Password to access your PeopleSoft dashboard
3. Click on the Learning Management tile
4. Once you verify your login, you will be directed to Brainier LMS, which will take you to your learning dashboard
5. You will be taken to your learning dashboard in Brainier. 
6. Once logged into Brainier, you will see your Dashboard and a “Search” option at the top of the page. Click the Search box and type the name of the training that you are required to complete “IND Sponsor and Investigator Training Course” OR “IDE Sponsor and Investigator Training Course.”

For additional guidance, please see this useful job-aid