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 trialsDigital 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 designEnsuring 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 trialsHow 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 researchRegulatory 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.
Tagged: regulatory science , clinical trials , quality by design , quality risk management , quality systemsRegulatory 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.
Tagged: regulatory science , collaboration , clinical trials , quality by design , academia , clinical researchRegulatory 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.
Tagged: regulatory science , project management , clinical trials , quality by design , academiaRegulatory 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.
Tagged: regulatory science , clinical trials , quality by design , quality management , control factors , product designRegulatory 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.
Tagged: regulatory science , clinical trials , quality by design , auditing and monitoring plansRegulatory 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 trialsRegulatory 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.
Tagged: regulatory science , clinical trials , budgets , logistics , moneyRegulatory 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 trialsRegulatory 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 devicesRegulatory 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 trialsRegulatory 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 devicesRegulatory 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 devicesRegulatory 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 devicesRegulatory 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 , pediatricsRegulatory 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 trialsRegulatory Science Symposium: Diversity in Clinical Trials in the Time of COVID-19 Session 6: Populations on the Fringe of Clinical Trial Enrollment
Tagged: study design , clinical trials , diversity , inclusion , barriers to patient access , disparities in research , vulnerable populations , representation , subject eligibility criteriaRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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: 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 trialsRegulatory 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.
Tagged: regulatory science , research ethics , clinical trials , legislationsRegulatory 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 , legislationsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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.
Tagged: regulatory science , research ethics , clinical trials , special populationsRegulatory 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 trialsRegulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 5: Roads to the Human Subjects Protection Program (OPRS and IRB) (2021)
Tagged: career development , regulatory science , clinical trials , quality science , clinical research , human subjects , institutional review board (irb) , ethicsRegulatory 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)
Tagged: career development , regulatory science , clinical trials , quality science , clinical research , human resources , clinical research coordinators (crcs)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