Ethics Consultation #1: Dealing with conflicts with your mentor

In this brief dramatization, a young researcher concerned her mentor/supervisor is conducting research in a scientifically improper manner seeks advice from an SC CTSI ethics consultant.

Tagged: research ethics, responsible conduct of research

Introduction to Clinical and Translational Research: Introduction to Research Ethics - Session 6

This online lecture reviews the history and development of the guidelines and federal regulations addressing ethical considerations associated with clinical and translational research.

Tagged: research ethics, responsible conduct of research

iStar Training Videos

Video tutorials show researchers how to use iStar, USC's online IRB (Institutional Review Board) application system.

Tagged: career development, responsible conduct of research

Monitoring and Auditing Bootcamp Session 2: FDA Inspections - Getting Ready (2016)

In this series, we will discuss regulatory complexities regarding clinical trials.

Tagged: regulatory science, responsible conduct of research

Monitoring and Auditing Bootcamp Session 3: Auditing GCP Systems for Data Integrity (2016)

In this series, we will discuss data integrity, GCP systems, regulatory framework enforcement, and auditing for data integrity

Tagged: regulatory science, responsible conduct of research

Monitoring and Auditing Bootcamp Session 4: Sponsor Audits: Data Handling and Reports (2016)

​In this series, we will discuss what a sponsor does with data after a clinical trial finishes at a site, focusing on audits.

Tagged: regulatory science, responsible conduct of research

Monitoring and Auditing Bootcamp Session 5: Workshop: GCP Audit Process and Checklist Scope (2016)

In this series, you will be asked to develop an audit plan and audit checklist for GCP Compliance.

Tagged: regulatory science, responsible conduct of research

Pharmacovigilance and Safety Reporting Boot Camp Session 8: Wrap up

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.

Tagged: regulatory science, research ethics, responsible conduct of research, clinical trials

Regulatory Science Series

Six lecturers provide in-depth reviews of the federal FDA and other regulations and guidelines that govern all aspects of clinical and translational research on new drugs and biomedical devices.

Tagged: device development, drug development, regulatory science, research ethics, responsible conduct of research

Special Populations Bootcamp Session 1: Pharmacometrics (2017)

In this session, we will discuss the pharmacometrics of special populations with special emphasis on children.

Tagged: informatics, regulatory science, responsible conduct of research, pharmacokinetics

Special Populations Bootcamp Session 2: Clinical Research Support (CRS) Group (2017)

In this session, we will discuss clinical trials at USC and the services available for assistance.

Tagged: innovation, regulatory science, responsible conduct of research, study design

Special Populations Bootcamp Session 3: Study Recruitment – Maximizing Impact (2017)

In this session, we will discuss how to engage populations into effective ways of involvement in clinical trials.

Tagged: community engagement, innovation, regulatory science, responsible conduct of research, research participant recruitment

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.