Training for Clinical Research Regulatory Affairs
HIPAA (Privacy)
Training Resource: Protecting Patient Information (HIPAA) (UPHS) (Link to Workday)
Frequency: At start of PSOM employment and every year
Oversight: Office of Privacy (https://oacp.upenn.edu/privacy/penndata/appropriate-use-of-penn-data/hipaa/)
CITI Modules for Human Subjects Protection
Training Resource: CITI Protection of Human Subjects Research Training - ORA
Frequency: Prior to starting clinical research. Initial training must be established, as of April 2019, renewal of CITI training for Human Research is no longer required at Penn.
Oversight: CITI training is overseen at Penn by the Institutional Review Board. Visit Penn's Institutional Review Boards (IRB)
IND Sponsor Training
Workday Learning Link HERE
IDE Sponsor Training
Workday Learning Link HERE
Expanded Access Sponsor Training
Workday Learning Link HERE
The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials
Workday Learning Link HERE
Introduction to Clinical Trials
Workday Learning Link HERE
Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review
Workday Learning Link HERE
Building Quality Management Systems for Sites and Sponsors
Workday Learning Link HERE
Key Skills for Ensuring Quality Control through Risk- Based Decision Making
Workday Learning Link HERE
Inspection Readiness: Best Practices for Managing Clinical Trial Inspections
Workday Learning Link HERE
Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
Workday Learning Link HERE
Coming Soon
Pharmacovigilance
Sponsor Responsibilities
Trial Master File
FDA Submissions
Other recommended trainings:
Managing Project Stakeholders
Workday Learning Link HERE
Project Leadership
Workday Learning Link HERE
FDA 101- Drug regulation, device regulation, history of biological regulations
Workday Learning Link HERE (Need link)
Regulatory Education for Industry (REdi): Clinical Investigator Training Course
External link to U.S. FDA website HERE