Clinical Trial Monitoring Module

The Southern California Clinical and Translational Science Institute (SC-CTSI) has developed a freely available self-study module that can be used to train academic researchers in essential concepts and practical approaches to monitoring of clinical studies.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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

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

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.

Tagged: regulatory science, clinical trials

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.

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

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

Tagged: device development, regulatory science, clinical trials

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.

Tagged: regulatory science, clinical trials

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.

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

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.

Tagged: regulatory science, clinical trials

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.

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

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.

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

Tagged: drug development, regulatory science, clinical trials

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.

Tagged: regulatory science, 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.

Tagged: regulatory science, research ethics, clinical trials, special populations

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.

Tagged: regulatory science, 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.