This six-part orientation is strongly recommended for all clinical research personnel who are new to UNC or new to research. The series will introduce research personnel to the UNC offices involved in clinical trials, discuss the federal and local regulations governing conduct of research, and provide an overview of best practices utilized in the implementation of clinical research. It is recommended that registrants complete both the CITI Good Clinical Practice (GCP) and CITI Human Subjects Protection (IRB/Ethics) modules prior to attending the orientation.
Each session of the orientation will be held on Wednesday afternoons, 1:30 to 4:00 pm. Research personnel are encouraged to attend all 6 modules, but may choose to attend only those of particular interest or relevance. The topics to be covered this week include:
UNC Hospitals Investigational Drug Services (Andrew Thorne) – 1:30 – 2:05 pm
Investigator-Initiated Study Processes (Valorie Buchholz) – 2:05 – 2:35 pm
ClinicalTrials.gov and ICMJE requirements (Monica Coudurier) – 2:40 – 3:20 pm
Adverse Event Evaluation and Documentation (Marie Rape) – 3:20 – 3:50 pm
IND and IDE Studies at UNC (Amanda Wood) – 3:50 – 4:00 pm