University of Southern California

Research

Orientation to Clinical Research at USC

Who Should Attend

Principal investigators, clinicians, project managers, research and nurse coordinators or administrators, data managers and all those associated with the development and conduct of human research studies and clinical trials.

Course Description

This two-day orientation provides an overview of the processes, committees and departments that clinical investigators work with throughout the submission, review, approval and conduct of human subject studies or clinical trials.

Topics include:
University Offices and Entities; Clinical Research Roles: An overview; Planning Research (Protocol Development); Contracting, Financial Management and Budgeting; Coordination of Ancillary Services/Support; IRB and Human Subjects Protection; iStar/Other Electronic Systems; Coordinating a Study; Compliance

Instructors

Speakers from the Office of Research, OPRS, CTO, SC CTSI, CISO, CTU and Office of Compliance.

Length

Four hours each day.

Next Session Dates

Part #1: February 12 | 8:00 – 12:00 PM
Part #2: February 19 | 8:00 – 12:00 PM
Location: Health Sciences Campus, Broad (CIRM) Center, 1st Floor Seminar Room

Reference Materials and Resources

Guide to Clinical Research at USC 7/22/14
Flow Chart: Industry-Sponsored Clinical Trials

February 12, 2014: Video Presentations and Slides

Office of Research: Introduction by Randy Hall
Video

Clinical Research at USC: An Overview by Silvia da Costa
Slides | Video

IRB and Human Subjects Protection by Susan Rose
Slides | Video

Non-Cisco Non-CTU Studies: How They Differ by Christine Tam
Slides | Video

Non-Cisco Non-CTU Studies: How They Differ by Katherine Hawthorne
Slides | Video

The IND and Clinical Trial Management by Frances Richmond
Slides | Video

Introduction to SPA by Kim Eudy
Slides | Video

Contracting, Financial Management and Budgeting by Soheil Jadali
Slides | Video

February 19, 2014: Video Presentations

Coordination of Ancillary Services by Diana Shycoff, Maria Apkarian & Jiwon Kim
Video

Coordinating a Clinical Trial by Anthony El-Khoueiry
Video

Compliance: Consideration Related to Clinical Trials by Dan Shapiro
Video

Planning, Development & Activation of a Clinical Trial Protocol by Anthony El-Khoueiry
Video