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).

Tagged: regulatory science, clinical trials, auditing and monitoring plans, investigator-initiated trials (iits), human subjects, international conference of harmonization (ich)

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.

Tagged: regulatory science, clinical trials

Digital Scholar Webinar: Breaking Down (Brick) Walls: Switching to Remote, Virtual, & Decentralized Clinical Trials

In this 60-minute webinar, Dr. Tenaerts presents the work of the Clinical Trials Transformation Initiative (CTTI) and discusses two main topics regarding digital clinical trials: (1) moving ongoing trials to remote and (2) planning for decentralized trials.

Tagged: clinical trials, clinical trial design

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.

Tagged: regulatory science, clinical trials

How to Submit a Grant Application and Activate Clinical Studies at USC

In this video, you will learn about the process of submitting a grant application at USC, and the various offices involved throughout the process. In addition, you will learn about what to do after your grant is funded, and how to go about activating and starting your clinical research study.

Tagged: career development, innovation, study design, funding, collaboration, clinical trials, budgets, logistics, money, clinical affairs & operations, clinical trial conduct, academia, clinical research

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials, 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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials, 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.

Tagged: regulatory science, clinical trials, 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.

Tagged: regulatory science, clinical trials, 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.

Tagged: regulatory science, clinical trials, medical devices, pediatrics

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: device development, drug development, regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: device development, regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

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

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, research ethics, clinical trials, legislations

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.

Tagged: device development, regulatory science, research ethics, clinical 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.

Tagged: drug development, regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

What We Can Learn About Successful Citizen Science from Microbiome Research

Citizen Science typically refers to research collaborations between scientists and volunteers, particularly (but not exclusively) to expand opportunities for scientific data collection and to provide access to scientific information for community members. Dr. Knight will discuss the American Gut Project (http://americangut.org) that was launched in November 2012 to discover the kinds of microbes and microbiomes “in the wild” via a self-selected citizen-scientist cohort. The result is a database that characterizes the diversity of the industrialized human gut microbiome on an unprecedented scale; reveals novel relationships with health, lifestyle, and dietary factors; and establishes a living platform for research discovery.

Tagged: research participant recruitment, project management, clinical trials

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.