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 researchIntroduction 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 researchiStar 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 researchRegulatory Science Series (2013)
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, responsible conduct of researchRegulatory Science Symposium: Monitoring and Auditing Session 1: Introduction to Monitoring, Auditing, and FDA Inspections & GCP (2016)
In this series, we will discuss regulatory complexities regarding clinical trials.
Tagged: regulatory science, responsible conduct of researchRegulatory Science Symposium: Monitoring and Auditing Session 2: FDA Inspections - Getting Ready (2016)
In this series, we will discuss regulatory complexities regarding clinical trials.
Tagged: regulatory science, responsible conduct of researchRegulatory Science Symposium: Monitoring and Auditing 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 researchRegulatory Science Symposium: Monitoring and Auditing 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 researchRegulatory Science Symposium: Monitoring and Auditing 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 researchRegulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 8: Wrap up (2018)
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 trialsRegulatory Science Symposium: Special Populations 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, pharmacokineticsRegulatory Science Symposium: Special Populations 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 designRegulatory Science Symposium: Special Populations 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 recruitmentRegulatory Science Symposium: Special Populations Session 8: Regulatory Considerations of Conducting Clinical Trials in Special Populations (2017)
In this session, we will discuss the extrinsic considerations for special populations.
Tagged: regulatory science, research ethics, responsible conduct of research, special populations