This course provides a comparative analysis of ICH E6(R2) and ICH E6(R3), highlighting key thematic similarities and differences. Participants will explore how the high-level themes of ICH E6(R3) impact clinical research practices and organizational processes. Through a practical framework, learners will assess compliance, identify procedural gaps, and prioritize actions to align with evolving regulatory expectations.
This course provides an in-depth understanding of financial processes in clinical research, with a focus on study payments, contract terms, and invoicing models. Participants will explore why payments are linked to specific study activities and learn to identify key payment milestones in clinical trials. The course will also differentiate between site milestone payments and IRB-approved participant compensation. Additionally, learners will gain insights into essential study contract terms and the standard invoicing model for ISPCTN studies. By the end of the course, participants will be equipped with the knowledge to navigate financial agreements and payment structures in clinical research effectively.
This course provides an in-depth understanding of the PhITT study protocol and schedule of activities as they relate to budget development. Participants will learn to identify key budget dimensions, including cost factors, resource allocation, and financial considerations necessary for conducting the PhITT study. The course also covers the contributors involved in budget development, outlining their roles and the approval steps required. Finally, participants will explore how the clinical trial budget aligns with the study's overarching priorities, ensuring financial feasibility while maintaining research integrity.
This course provides an in-depth exploration of the essential components of clinical research budgeting and compliance. Participants will review the purposes served by protocol and study budgets, gaining insight into their role in ensuring financial feasibility and regulatory adherence. The course covers the budget creation process, highlighting key items to include for comprehensive financial planning. Additionally, learners will develop an understanding of billing compliance considerations for patient care costs and multiple funding sources.
Gain a comprehensive understanding of the FDA's structure and its regulatory role in medical products, including drugs, biologics, and medical devices. Explore the mission, vision, and core functions of the FDA's Office of Pediatric Therapeutics, emphasizing its role in pediatric clinical trials. Differentiate between key regulatory submissions—INDs, IDEs, NDAs, BLAs, and PMAs—and understand the FDA’s involvement across the medical product development lifecycle. The course will highlight the unique regulatory considerations for pediatric therapeutics, equipping participants to navigate the complexities of pediatric clinical research effectively.
This course offers healthcare professionals a comprehensive understanding of the 2023 AAP Clinical Practice Guidelines for the evaluation and treatment of childhood and adolescent obesity. It emphasizes the multifaceted nature of obesity, including environmental, social, biological, and genetic contributors, while addressing the negative impacts of weight bias and stigma.
In this comprehensive course, participants will delve into the critical issue of language inequities and the vital role of language justice in research. The course is designed to equip researchers with the knowledge and tools necessary to recognize, address, and mitigate language barriers that impact non-English speaking communities.
This course provides an in-depth overview of the essential components for conducting FDA trials. Participants will gain a comprehensive understanding of research team roles, necessary staff requirements, essential training and certifications, and best practices for FDA audits and documentation.
This course offers a comprehensive guide to managing adverse events, preparing for and responding to FDA audits, and mastering communication with the FDA and Institutional Review Boards (IRBs). Participants will gain critical skills and knowledge to ensure compliance and effectiveness in clinical trials.
This comprehensive course provides essential insights and practical knowledge for conducting FDA trials. Participants will explore good documentation practices (GDP) for ALCOA-C compliance, prepare for and respond to FDA audits, understand varying requirements for FDA and ISPTCN interventional clinical trials, and review the roles and training needs of research team members, including pharmacists.
