WebThe CITI Program training courses required by OSF cover four core areas: Human subjects research (HSR) Responsible conduct of research (RCR) Conflicts of interest (COI) Good Clinical Practice (GCP) - only required for FDA-regulated research OR NIH-funded clinical trials Training Requirements for FDA-regulated or NIH-funded clinical trials WebFDA-Regulated Research University of Kentucky Research FDA-Regulated Research Food and Drug Administration (FDA) Resource Links by Topic [ PDF] Jump to: Investigational Drugs Medical Devices What is a drug? What is a drug clinical investigation? What is a biologic? When is a dietary supplement considered to be a drug?
CITI Course Modules – Institutional Review Board
WebThe study is FDA Regulated if any of the following items apply and are checked on the Regulatory Page of IRB Online Approved Drug, Device, Biologic or HUD (research on) … WebThis online training includes 11 modules pertaining to FDA regulated research activities. These modules are specific to UC. ... (CITI) at the Biomedical Research Alliance of New York (BRANY). The CITI curriculum is customized for you, based on the kind of research in which you are involved. A series of registration questions will identify the ... korean coffee milk
Biomedical (Biomed) Refresher 2 CITI Program
WebCITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September … WebThe CITI Good Clinical Practice Course for Clinical Investigations of Devices Overview of U.S. FDA Regulations for Investigational Devices Investigator Obligations in FDA-Regulated Clinical Investigations of Devices Conducting Investigator-Initiated Clinical Investigations of Devices Managing Investigational Devices According to GCP … WebThis includes research that is FDA regulated, greater than minimal risk, or reviewed under the pre-2024 Common Rule. The eIRB sends out notifications to the Principal Investigator, Lead Investigator and Lead Study Coordinator at … korean coffee bread