Clinical Research Training (formerly Intro to Clinical Research/Key Concepts)
Training for investigators and Research Staff Conducting FDA-Regulated Clinical Trials at Emory
For all investigators and many research staff (see below) who are conducting FDA-regulated clinical trials at Emory, the institution requires completion of additional training every three years. This is in addition to the IRB-required CITI training in human subjects’ research ethics. In addition, NIH-funded clinical trials are required to complete GCP-ICH course training every three years per their policy.
The required training modules are intended to enhance an investigator’s ability to 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, the training describes the regulatory requirements and best practices for their various responsibilities.
- 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." Please see the OCR website for more information, and 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* must take an online GCP-ICH course that contains three additional Emory-specific modules, also through the CITI online system.
- Additional information about training requirements per research role can be accessed here.
*To see if your study activities fall under the training mandate, please see this document.
For research studies that fall under this additional training requirement, but are not NIH-funded:
- For investigators, the IRB will accept the CITI GCP-ICH course and ICH course of those who completed the training after June 1, 2016. If investigators did not complete the CITI GCP-ICH course, or never completed the Key Concepts training after June 1, 2016, they may provide an older GCP-ICH course training certificate.
- For the investigator’s research team, the IRB will accept the CITI Clinical Research Coordinator or the 2-day Introduction to Clinical Research training certificates of those who completed the training after June 1, 2016. If the investigator’s research team did not complete either course after June 1, 2016, the research team will need to review the Office for Clinical Research Training web page to determine the appropriate training required for their job role.
Registration for the 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. Once completed, the training certification needs to be uploaded into the relevant eIRB application. As part of the IRB approval process, IRB staff verify that valid certification is documented in eIRB for new studies and for amendments adding new clinical investigators.
For any additional questions about this training requirement, please contact the Office of Clinical Research at OCR@emory.edu or 404-778-4960.
Note: The IRB is still requiring the submission of Key Concepts/Intro to Clinical Research training certificates with IRB applications.
If you have any questions, please contact Maria Davila at email@example.com.