1. Whom do I contact?
Training is required for those who are conducting or coordinating FDA-regulated clinical trials. Refer to the Clinical Research Education Requirements and Revised Training Letter for Emory’s education requirements for FDA-regulated clinical trials. Refer to Training for Clinical Research Staff for other courses that may be needed to function in you role as investigator.
Investigator is defined as any PIs, Co-Is, fellows, or other Emory employees functioning in the role of an investigator.
• Training in Good Clinical Practices (GCP) is required for investigators involved in the conduct of FDA-regulated clinical trials at Emory in order to improve the quality of clinical trials, the protection of research participants and the generalizability of study results. Some NIH institutes also require GCP training.
• In addition to IRB required training, all new investigators (new to Emory or new to research) starting after June 1, 2016 who are planning to participate in a FDA-regulated clinical trial must complete the CITI course entitled, “Good Clinical Practice and ICH”. This course includes 13 CITI GCP modules, plus 3 additional Emory modules as follows:
o Emory Institutional & Regulatory Information
o Audit Findings in Clinical Trials at Emory
o HIPAA and Research [available in Emory Learning Management System (ELMS)]
• Every 3 years, investigators must complete the “CITI Biomedical Refresher” course currently required by the IRB, plus 3 additional Emory modules as follows:
o Emory Institutional & Regulatory Updates
o Audit Findings in Clinical Trials
o Ethical Issues in Clinical Research