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 Trial Startup Bootcamp 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.

Clinical Trial Startup Bootcamp 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.

Clinical Trial Startup Bootcamp 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.

Clinical Trial Startup Bootcamp 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.

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

Clinical Trials with Medical Devices Boot Camp Session 1: Introduction (2019)

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

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp 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.

Clinical Trials with Medical Devices Boot Camp Session 9: Wrap Up (2019)

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

Emerging Technologies/Treatments Bootcamp 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.

Emerging Technologies/Treatments Bootcamp 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.

Emerging Technologies/Treatments Bootcamp 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.

Emerging Technologies/Treatments Bootcamp 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.

Emerging Technologies/Treatments Bootcamp 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.

Emerging Technologies/Treatments Bootcamp 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.

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.

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 1: Introduction & Knowledge Quiz (2019)

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 2: Investigator’s Responsibilities: Industry Sponsored Trials (2019)

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 3: Investigator’s Responsibilities: Investigator Initiated Trials (2019)

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 4: Clinical Trial Contracts (2019)

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 5: Legal Considerations of Compassionate Use (2019)

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 6: Liability and Indemnification (2019)

Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 8: Wrap Up (2019)

Monitoring and Auditing Bootcamp Session 1: Introduction to Monitoring, Auditing, and FDA Inspections & GCP (2016)

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

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

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

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

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.

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.

Patient-Centered Drug Development and Real World Evidence/Data Boot Camp Session 1: Introduction (2019)

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

Patient-Centered Drug Development and Real World Evidence/Data Boot Camp Session 3: Patient-Centered Drug Development (2019)

Patient-Centered Drug Development and Real World Evidence/Data Boot Camp Session 4: Rare Diseases (2019)

Patient-Centered Drug Development and Real World Evidence/Data Boot Camp Session 5: Real World Evidence and Real World Data (2019)

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

Patient-Centered Drug Development and Real World Evidence/Data Boot Camp Session 7: Wrap-up (2019)

Pharmacovigilance and Safety Reporting Boot Camp Session 1: Introduction (2018)

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

Pharmacovigilance and Safety Reporting Boot Camp 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.

Pharmacovigilance and Safety Reporting Boot Camp 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.

Pharmacovigilance and Safety Reporting Boot Camp 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.

Pharmacovigilance and Safety Reporting Boot Camp 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.

Pharmacovigilance and Safety Reporting Boot Camp 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.

Pharmacovigilance and Safety Reporting Boot Camp 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.

Pharmacovigilance and Safety Reporting Boot Camp 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 Aspects of Clinical Trial Design Bootcamp Session 1: Intro/Key Terms (2018)

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

Regulatory Aspects of Clinical Trial Design Bootcamp 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 Aspects of Clinical Trial Design Bootcamp 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 Aspects of Clinical Trial Design Bootcamp 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 Aspects of Clinical Trial Design Bootcamp 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 Aspects of Clinical Trial Design Bootcamp 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 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: 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 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)

Special Populations Bootcamp Session 1: Pharmacometrics (2017)

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

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.

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.

Special Populations Bootcamp 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.

Special Populations Bootcamp 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.

Special Populations Bootcamp 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.

Special Populations Bootcamp 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.

Special Populations Bootcamp Session 8: Regulatory Considerations of Conducting Clinical Trials in Special Populations (2017)

In this session, we will discuss the extrinsic considerations for special populations.