Regulatory Science Virtual Symposium: “Make Informed Decisions: Key Statistical Principles to Clinical Trial Design” Session 1: Introduction (2022)

1. Introduction
   1. A big welcome to attendees from industry, academia, MPTX classes, etc.!
2. SC CTSI Clinical Research Support (CRS)
   1. A comprehensive service aiding investigators and research teams to develop, activate, conduct, and report results for human subject research studies
3. Clinical Trial Quality Training Series
   1. Free e-Learning modules avalible for public use
   2. Created by the USC Department of Regulatory and Quality Sciences and Regulatory and Knowledge Support (RKS) core within SC CTSI
   3. Purpose of modules: to cross train investigators in the practices of monitoring and auditing
   4. For access, go to: https://uscregsci.remotelearner.net
4. Georgia CTSA and SC CTSI: Online Course Catalog
   1. Offers free trainings for clinical research workforce to the first 400 registrants
   2. Contact hours can be used for CRP certification renewal
   3. Link: https://twd.ce.emorynursingexperience.com/
5. For more information about the USC Regulatory and Quality Sciences, see the following link: http://regulatory.usc.edu
6. Degree Programs
   1. Five Graduate Programs: DRSC, MS Regulatory Science, MS Management for Drug Development, and MS Medical Product Quality
   2. Certificates: Food Safety, Regulatory Science, Early Drug Development, Clinical Design and Management, Patient and Product Safety
7. Symposiums
   1. Occurring since 2015!
   2. Symposium recordings are easily accessible for viewing on the SC CTSI’s online educational library: https://sc-ctsi.org/training-education/courses?audience=researchProfessionals
   3. Topics for future symposia are from your feedback
8. Today’s symposium topic
   1. Role and significance of statistics in clinical trial design
9. Agenda
10. Program Evaluation
    1. Please complete the evaluation at the end of the symposium to receive your certificate.

Accompanying text created by Annie Ly | RKS Project Administrator, SC CTSI  lyannie@usc.edu