- Welcome! – by Dr. E. Pacifici
- Regulatory landscape differs across the process (not regulated vs. highly regulated)
- 5 graduate streams available at USC Regulatory Science department
- Poll Time!
- How would you describe yourself? Ex. Regulatory Professional
- How long have you been in your role?
- In which of the following types of studies are you involved in?
- What do you find to be the greatest hurdle in starting a clinical trial?
- Over the last 3 years, starting a clinical trial has become easier/more difficult/unchanged
- Do you currently use social media in clinical trials?
- A referral payment for a clinical must be minimal so that it is not seen as coercive (T/F)
- An institution can include discounted serviced for clinical trail sponsors as part of the clinical trial agreement (T/F)
- The Principal Investigator and the study coordinator share the responsible for the conduct and oversight of the research including human subject protection (T/F)
- Which of the following is not required criteria for IRB approval?
- At what point should a research team consider study feasibility?
- Presentation Title: Clinical Research Support (CRS) Group: Supporting Investigator-Initiated Trials of USC
- Led by April W. Armstrong, MD MPH
- Challenges in conducting Investigator-Initiated Studies
- Clinical Research Support (CRS) at USC
- Group Services ex. Research navigation, feasibility review, recruitment
- Help from beginning to end of research project
- Starting off Right in Clinical Trial Start-Up
- A Joint Presentation by Kevin Kelly MD., PhD. And Joyce Nancarrow Tull, MSN, CCRP
- Mostly common sense---just the basics
- Key Elements of Success in Clinical Objectives of This Segment
- What are the Key Elements in Successful Study Start-Up?
- Research is a collaborative effort
- Communication
- Baseline Trial Information
- Established Metrics
- The Right, “Knowledgeable” Team
- Complete Documents
- Clear Process
- CISO Process Map
- User-Friendly Database
- Tracking and Transparency
- The Right Resources
- Positive Attitude
- Research is a collaborative effort
- Dr. Pacifici’s Conclusions/Q&A with Joyce Nancarrow Tull
- Importance of Logistics ie. Having clear-cut processes in place
- In cancer, there is pre-site visit and look at facilities, appropriate documents, and faculty for the trial site choice
- USC has an expanded feasibility check-list
- Final CIC review is when the trial is allowed to start
- Polishing Tool from USC Norris Cancer Center
- Use of Databases- interface, how it is set up, function
- Challenge: Knowing what your systems can do for you and how can you bridge the gaps
Eunjoo Pacifici, PharmD, PhD
Director, Regulatory Knowledge and Support