Orientation to Clinical Research at USC Randolph Hall Vice - PowerPoint PPT Presentation

Orientation to Clinical Research at USC Randolph Hall Vice President, Research

Growing Clinical Research at USC  Expand access to novel and promising therapies, and build reputation as center for innovative and effective patient ‐ centered care.  Expedite execution of clinical trial agreements, and create master agreements with major sponsors.  Improve research IT, with clinical trial management system, clinical data warehouse, supplementing TARA  Increase knowledge of how to conduct trials

Aims of Training  Overview of processes for planning and executing research for human subjects in the clinical setting, at USC.  Introductory level understanding of all aspects of clinical trials  Course is for:  New clinical investigator  Research coordinators  All others who participate in executing a clinical research study

Contributors  Clinical and Translational Science Institute and its Clinical Trials Unit  Cancer Investigators Support Office  Office for the Protection of Research Subjects  Office of Compliance  Clinical Trials Office  Office of Research

Certificate of Completion  Awarded after attendance in entirety at both sessions  Demonstration that you have received training on basic processes for clinical research at USC.  Not based on examination.  If you are unable to attend both sessions, we’ll have a record of the one you attended. You may complete the certificate during next course offering in the spring (date to be determined).  Certification of completion not currently required, but may be in future.

Other Training at USC (http://oprs.usc.edu/education/)  Human subjects protection training  Good Clinical Practice  HIPAA Training  Responsible Conduct of Research  Conflict of Interest  Grants Management

Follow-up Training and Certification Outside USC  Association of Clinical Research Professionals:  Professional development program, in ‐ person and online  Certified Research Associate, Certified Research Coordinator, PI Certification, CTI Certificate  Society of Clinical Research Associates  Professional development programs, in ‐ person and online  Certified Clinical Research Associate  MAGI (Model Agreements and Guidelines International)  Clinical Research Contract Professional  Certifications Depend on Passing Exams

Future Offerings at USC  Clinical Trials at USC Orientation: Offered Again in Spring, Date TBD (thereafter, likely once per year)  Clinical Trials Administration: Offered First Time Later this Fall, Date TBD

https://research.usc.edu/clinical-trials-at-usc/

DAY 1 WEDNESDAY, SEPTEMBER 18, 2013 TIME TOPIC INSTRUCTOR 8:00 am – 8:10 am Introduction Randolph Hall 8:10 am – 8:30 am Clinical Research at USC: An Overview Silvia da Costa 8:30 am – 9:45 am Contracting, Financial Management Soheil Jadali and Budgeting 9:45 am – 10:15 am BREAK 10:15 am – 10:45 am Compliance: Considerations Related Dan Shapiro to Clinical Trials 10:45 am – 12:00 pm IRB and Human Subjects Protection Susan Rose

DAY 2 WEDNESDAY, SEPTEMBER 25, 2013 TIME TOPIC INSTRUCTOR 8:00 am – 9:00 am Planning Research Anthony El ‐ Khoueiry 9:00 am – 9:30 am Coordination of Ancillary Services Anthony El ‐ Khoueiry 9:30 am – 10:00 am BREAK 10:00 am – 12:00 pm Coordinating a Study Anthony El ‐ Khoueiry