Learn At Your Own Pace

Clinical Trial Quality Training Series

The D.K. Kim International Center for Regulatory Science, in conjunction with the Southern California Clinical and Translational Science Institute, has developed open-access, self-study modules that trains academic researchers in essential concepts and practical approaches to monitoring and auditing clinical studies. The module series addresses the need for quality management across the clinical trial lifecycle as stated in the latest addendum to ICH Guideline for Good Clinical Practice (GCP), E6(R2).

Clinical Trials Hurdles Session 1 and 2: Challenges of Clinical Trial Management (2015)

In this series, we will discuss how to successfully support and manage clinical trials.

Clinical Trials Hurdles Session 3 : FDA GCP Inspections (2015)

In this series, we will discuss how the FDA investigators would conduct their GCP investigation.

Clinical Trials Hurdles Session 4: Trial Master Files (2015)

In this series, we will discuss how to successfully support and manage clinical trials.

Clinical Trials Hurdles Session 5: Clinical Trial Data Disposition, Results, and Transparency Group (2015)

In this series, we will discuss how to successfully support and manage clinical trials

Ensuring quality in clinical trials: monitoring concepts and CRC development training (2018)

Audience members will learn about a readily available, user-friendly, self-paced study module that provides training on essential concepts and practical approaches to monitoring.

Regulatory 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.

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 1: Introduction (2020)

In this series, we will discuss the principles of quality by design.

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 2: What do we mean by Quality by Design (2020)

In this series, we will discuss the principles of quality by design.

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 3: CTTI’s Approach to QbD (2020)

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 4: Developing QbD Tools for Clinical Researchers (2020)

In this series, we will discuss the principles of quality by design.

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 5: Integrating QbD into Team Science, and Project Management for Research Success (2020)

In this series, we will discuss the principles of quality by design.

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 6: Applying Design for Six Sigma (2020)

In this series, we will discuss the principles of quality by design.

Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 7: Wrap-Up (2020)

In this series, we will discuss the principles of quality by design.

Regulatory Science Symposium: Clinical Trial Startup Session 1: Introduction/Clinical Research Support Office/Starting Off Right: Elements of Success: A Clinical Trial Site’s Perspective (2016)

In this session, we will discuss how to begin the clinical trial process feasibly and correctly and the importance of such a start, briefly focusing on the clinical trial process in the field of cancer.

Regulatory Science Symposium: Clinical Trial Startup Session 2: Pre-Award Activities: Contract and Budget/Managing Logistics: Study Drug, Specimen, Space (2016)

In this session, we will discuss the management of logistics and budgeting of clinical trials.

Regulatory Science Symposium: Clinical Trial Startup Session 3: Recruiting and Screening Subjects: Marketing, Social Media, and EHR/Interacting with IRB (2016)

In this session, we will discuss how to effectively recruit subjects for a clinical trial and how modern technology and social media plays a role in the recruitment and screening processes of clinical trials.

Regulatory Science Symposium: Clinical Trial Startup Session 4: Administering Informed Consents: Special Populations/Panel Discussion (2016)

In this session, we will discuss the significance of informed consent before ending with a panel discussion.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 1: Introduction (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 2: History, Terms/Definitions and Regulatory Requirements (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 3: IRB Reviews on Medical Device Trials (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 4: Quality at the Data Level (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 5: Medical Device Feasibility Clinical Trials – SetPoint Medical Case Study (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 6: Advanced International Trials with Medical Devices (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 7: Auditing of Medical Device Trials (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 8: Gaps and Opportunities in Pediatric Device Trials (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 9: Wrap Up (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory Science Symposium: Diversity in Clinical Trials in the Time of COVID-19 Session 1: Introduction

Regulatory Science Symposium: Diversity in Clinical Trials in the Time of COVID-19 Session 2: What Do We Mean by Diversity in Clinical Trials?

Regulatory Science Symposium: Diversity in Clinical Trials in the Time of COVID-19 Session 8: Wrap-Up

Regulatory Science Symposium: Emerging Technologies/Treatments Session 1 - Regulatory Considerations (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Regulatory Science Symposium: Emerging Technologies/Treatments Session 2: Gene Therapy Trials and Tribulations (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Regulatory Science Symposium: Emerging Technologies/Treatments Session 3: Clinical Trials for Stem Cell Therapies (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Regulatory Science Symposium: Emerging Technologies/Treatments Session 4: CT Enabling Technologies – Decentralized Clinical Trials (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Regulatory Science Symposium: Emerging Technologies/Treatments Session 5 - Immunotherapy Trials (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Regulatory Science Symposium: Emerging Technologies/Treatments Session 6: Cutting Edge Technologies and Humanitarian Devices (2017)

In this series, we will discuss regulatory considerations for conducting clinical trials in the era of emerging technologies and treatments.

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 1: Introduction & Knowledge Quiz (2019)

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 2: Investigator’s Responsibilities: Industry Sponsored Trials (2019)

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 3: Investigator’s Responsibilities: Investigator Initiated Trials (2019)

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 4: Clinical Trial Contracts (2019)

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 5: Legal Considerations of Compassionate Use (2019)

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 6: Liability and Indemnification (2019)

Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 8: Wrap Up (2019)

Regulatory 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.

Regulatory Science Symposium: Monitoring and Auditing Session 2: FDA Inspections - Getting Ready (2016)

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

Regulatory 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

Regulatory 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.

Regulatory 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.

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 1: Introduction (2019)

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 2: History, Terms and Definitions (2019)

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 3: Patient-Centered Drug Development (2019)

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 4: Rare Diseases (2019)

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 5: Real World Evidence and Real World Data (2019)

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 6: Case Study: From Discovery to Practice and Survivorship (2019)

Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 7: Wrap-up (2019)

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 1: Introduction (2018)

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

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 2: Regulatory Requirements (2018)

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

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 3: Safety Reporting in Investigator-Initiated Trials (2018)

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

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 4: Safety Reporting from Other Sources (2018)

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

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 5: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 1 (2018)

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

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 6: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 2 (2018)

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

Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 7: Adverse Event Reporting (2018)

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

Regulatory 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.

Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 1: Intro/Key Terms (2018)

In this session, we will discuss commonly used terms in clinical trial design and regulatory science.

Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 2: Evolution of FDA’s View of a Well-Designed Clinical Trial (2018)

In this session, we will discuss how to conduct an effective clinical trial from the perspective of the FDA.

Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 3: Classic and Novel Designs Used in Regulatory Approvals (2018)

In this session, we will discuss how classic and novel designs are used in regulatory approvals and the benefits and consequences of utilizing these types of designs.

Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 4: Unique Designs for Medical Device Trials (2018)

In this session, we will discuss how medical device trials are conducted in Europe and the United States and how these trials differ from pharmacological trials.

Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 5: Case Studies and Future Trends (2018)

In this session, we will discuss trends in drug development in 2017 and look at case studies that reflect these trends.

Regulatory Science Symposium: Regulatory Aspects of Clinical Trial Design Session 6: Panel Discussion (2018)

In this session, audience members ask the panel questions concerning real world evidence, the gold standard for devices, adaptive trial design, sample size of control group, and legislation changes in European drug regulations.

Regulatory Science Symposium: Special Populations Session 1: Pharmacometrics (2017)

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

Regulatory 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.

Regulatory 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.

Regulatory Science Symposium: Special Populations Session 4: Research - Engaging Adolescents and Young Adults (2017)

In this session, we will discuss the importance and concerns of dealing with adolescents in clinical trials.

Regulatory Science Symposium: Special Populations Session 5: Clinical Research in Pregnant Women and Neonates (2017)

In this session, we will discuss the special population research and behaviour on women and neonates.

Regulatory Science Symposium: Special Populations Session 6: Working in Criminal Justice Settings (2017)

In this session, we will discuss the importance and recommendations on the incarcerated population, with the prisoners as research subjects.

Regulatory Science Symposium: Special Populations Session 7: Geriatric Subjects and Trials in the Cognitively Impaired (2017)

In this session, we will discuss the research for cognitive impairment outcomes and targets for interventions.

Regulatory 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.

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 2: CTSI Clinical Study Design Types (2023)

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 1: Introduction (2021)

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 2: From Academics to Industry – A Physician Researcher Perspective (2021)

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 3: Clinical Supply Chain Management: Dude, Where’s My Patient Benefit? (2021)

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 4: Understanding Clinical Research Management at Academic Institutions (2021)

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 5: Roads to the Human Subjects Protection Program (OPRS and IRB) (2021)

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 6: Knocking on HR’s Door: Do You Have What it takes to be a CRP? (2021)

Regulatory Science Virtual Symposium: “Emerging Technologies in the Medical Device Industry” Session 1: Introduction (2022)

Regulatory Science Virtual Symposium: “Innovation to Translation: Role of Genomics in Medical Product Development:” Session 2: Genomics and Regulation (2021)

Regulatory Science Virtual Symposium: “Innovation to Translation: Role of Genomics in Medical Product Development:” Session 3: Genomics and Personalized Medicine – A View from a Drug Development and Regulatory Science Perspective (2021)

Regulatory Science Virtual Symposium: “Innovation to Translation: Role of Genomics in Medical Product Development:” Session 4: Pharmacogenomics Considerations for Clinical Research and Implementation (2021)

Regulatory Science Virtual Symposium: “Innovation to Translation: Role of Genomics in Medical Product Development” Session 1: Introduction (2021)

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

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 1: Introduction (2023)

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 3: Gender, Race, and Ethnicity in Clinical Trials (2023)

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 4: Types and Trends (2023)

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 5: Medical Device Trials (2023)

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 6: Statistical Challenges of Adaptive and Innovation Study Designs (2023)