Clinical Trial Safety Case Management: A Principal Investigator’s Case-Based Exercise

Students will choose any of 3 provided case scenarios of AE/ADR of different severity in the clinical study. They will act as the Principal Investigators. They are required to evaluate the case and provide their solutions and comments by submitting a memo to file in addition to the completed forms to Sponsor and IRB. Students will practice their clinical trial administration and Investigational product management skills acting as Principal Investigator exercising his/her main responsibilities related with study subjects’ safety, and data integrity.