Human Subjects Training
Clinical Research Training
FDA Training and Continuing Education Resource Page Co-sponsored by FDA's CDER, Office of medical Policy and the Duke University School of Medicine. Good Clinical Practice (GCP) Key Topics by Jean Toth-Allen, PhD Investigator Responsibilities-Regulation and Clinical Trials by Cynthia F. Kleppinger, M.D. Safety assessment in Clinical Trials and Beyond by Yuliya Yasinskaya, MD, Medical Officer, Center for Drug Evaluation and Research Federal grant proposals (all proposals to NSF, training proposals for NIH) normally include a requirement that all trainees are provided with instruction in the Responsible Conduct of Research (RCR). An RCR program normally covers these areas: ethics, conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. The Office of Postdoctoral Affairs offers formal instruction and support to Postdoctoral Fellows in an effort to enhance the training experience at UCLA and promote successful careers in science. It is an information warehouse providing an avenue of communication among Postdoctoral Fellows, Faculty and Administrators. Research Conflicts of Interest training addresses the importance of ensuring financial interests do not affect, or appear to affect, the design, conduct of reporting of research or compromise the protection of human subjects. Additional Training for Animal Care and Environmental Health & Safety in Research is available online. See the Training tab to view the courses offered and click on the course title to view the course summary. The course title link at the top of the summary will take you into the online class. Access requires a username and password, which can also be requested online. Browse an overview of training and advancement opportunities available primarily via CTSI programs, but with an ever-increasing inclusion of other, non-CTSI opportunities. The US Department of Health and Human Services (DHHS) Office of Research Integrity (ORI) offers web-based Research Misconduct training and resources to help researchers understand the types of misconduct and how universities handle them. US Food and Drug Administration (FDA)
Training and Continuing Education
FDA Office of Good Clinical Practice-
Investigator Responsibilities
Clinical Investigator Financial Disclosures
Expanded access to and charging for investigational drugs and devices
https://fda.report/media/84996/2012-Clinical-Investigator-Course---Good-clinical-practice-%28Toth-Allen%29.pdf
Division of Good Clinical Practice Compliance
Federal regulations covering clinical research and clinical investigator obligations
Discuss specific problems seen during FDA inspections at clinical sites
Discuss various methods that can be used to ensure compliance with federal regulations and study protocol
https://cersi.umd.edu/sites/cersi.umd.edu/files/D2S07-Kleppinger-v1.pdf
Sources of safety information
Sources of safety information
Safety monitoring/ AE ascertainment·
AE Coding
Safety Reporting
Post-marketing safety (MedWatch) reporting
https://cersi.umd.edu/sites/cersi.umd.edu/files/S03%20-%2004%20Yasinskaya.pdfGood Clinical Practice
Responsible Conduct of Research
Office of Postdoctoral Affairs
Research Conflicts of Interest
Animal Care / Environmental Health & Safety
UCLA Training & Advancement Opportunities
Research Misconduct