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 trialsClinical 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.
Tagged: regulatory science, clinical trials, budgets, logistics, moneyClinical 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, technologyClinical 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 populationsClinical 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 trialsClinical 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 scienceClinical Trials Hurdles Session 4: Trial Master Files (2015)
In this series, we will discuss how to successfully support and manage clinical trials.
Tagged: regulatory scienceClinical 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 scienceEmerging 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 scienceEmerging 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 scienceEmerging 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 scienceEmerging 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 scienceEmerging 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 scienceEmerging 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 scienceMonitoring 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.
Tagged: regulatory science, responsible conduct of researchMonitoring 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 researchMonitoring 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 researchMonitoring 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 researchMonitoring 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 researchRegulatory 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 trialsRegulatory 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.
Tagged: regulatory science, research ethics, clinical trials, legislationsRegulatory 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, legislationsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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 trialsRegulatory 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