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 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.

Tagged: regulatory science, research participant recruitment, social media/internet research, technology

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.

Tagged: regulatory science, research ethics, informed consent, special populations

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

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

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

Tagged: regulatory science

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

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

Tagged: regulatory science

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

Tagged: regulatory science

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.

Tagged: regulatory science

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.

Tagged: regulatory science

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.

Tagged: regulatory science

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.

Tagged: regulatory science

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.

Tagged: regulatory science

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.

Tagged: regulatory science

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

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

Tagged: regulatory science, responsible conduct of research

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

Tagged: regulatory science, responsible conduct of research

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.

Tagged: regulatory science, responsible conduct of research

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.

Tagged: regulatory science, responsible conduct of research

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

Regulatory Science Series

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.

Tagged: device development, drug development, regulatory science, research ethics, responsible conduct of research

Special Populations Bootcamp Session 1: Pharmacometrics (2017)

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

Tagged: informatics, regulatory science, responsible conduct of research, pharmacokinetics

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.

Tagged: innovation, regulatory science, responsible conduct of research, study design

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.

Tagged: community engagement, innovation, regulatory science, responsible conduct of research, research participant recruitment

Special Populations Bootcamp Session 4: Research - Engaging Adolescents and Young Adults

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

Tagged: regulatory science, research ethics, social media/internet research

Special Populations Bootcamp Session 5: Clinical Research in Pregnant Women and Neonates

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 6: Working in Criminal Justice Settings

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

Tagged: regulatory science, special populations

Special Populations Bootcamp Session 7: Geriatric Subjects and Trials in the Cognitively Impaired

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

Tagged: regulatory science, clinical trials

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