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 … WebCITI: Conducting Investigator-Initiated Studies According to FDA Regulations and GCP - Describes the role of sponsor-investigator, help determine whether an IND or IDE is …
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Web10. What is the “Biomedical Research Group”? 11. What is the “Social/Behavioral Research Group”? 12. What if I need to add research with Minors or FDA-regulated research modules after completing CITI training? 13. I am conducting a clinical trial, but it also includes a behavioral survey. Which Learner Group should I choose? 14. WebThe thirteen principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. Although these principles were written with drug, device, and biological studies in mind, most of these principles also apply to social ... isca italy map
Training Requirements UArizona Research, Innovation & Impact
WebCITI Access Information; Human Research Compliance Monthly Education and Training Series (HRC METS) ... FDA regulations at 21 CFR 56.104(c) permit the emergency use of a test article without IRB review when the need for an investigational drug or biologic arises in a situation that does not allow time for submission of an IND. In such a case ... WebBiomed Refresher 2 – FDA-Regulated Research Biomed Refresher 2 – HIPAA and Human Subjects Research Biomed Refresher 2 – Conflicts of Interest in Human Subjects Research CME/CEU Credits To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first. WebGood Clinical Practice for Drug/Device Researchers: The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices (ID: 1350) Overview of New Drug Development (ID: 1351) ... Investigator Obligations in FDA-Regulated Research (ID: 1356) Managing Investigational Agents According to GCP Requirements (ID: 1357) is caitriona balfe irish