ECHO ISPCTN PROFESSIONAL DEVELOPMENT

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.

This focused course equips participants with the essential knowledge and skills to conduct and prepare for monitoring visits in clinical trials. Learn about the key components of a monitoring visit, crucial preparation tasks, and the specific roles of team members during these visits.

This course provides an essential overview of the Code of Federal Regulations (CFR) in clinical research, its purpose, and the specific responsibilities of the Principal Investigator (PI), including those outlined in the FDA Form 1572.

This course provides insights into the functional roles and responsibilities of the professional development and research writing teams within the Data Coordinating and Operations Center (DCOC) and the Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award States Pediatric Clinical Trials Network (ISPCTN).