The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. Clinical research in pediatric populations must follow the same regulations that adult clinical research follows, yet there are additional safeguards for children in clinical research, challenges associated with consent and study management for families and nuances in these populations that we don’t experience in the adult clinical research community. When you engage a child for participation in a clinical research program, you are engaging the entire family. Parents have a different risk/benefit profile for their child than they do for themselves. Navigating this complex environment with compassion, integrity and processes that embed compliance into every interaction are critical to protecting this vulnerable population and ensuring we can bring the best treatments forward as quickly as possible. Whether you're just getting started in pediatric clinical research or you have decades of experience, this program is designed to elevate your understanding and application across the regulatory environment, informed consent and assent, recruitment and retention, feasibility, budgeting, contracting and financial management with compliance tips and tricks along the way. 

LEARNING OBJECTIVES

• Discuss ethical considerations when conducting clinical research in the pediatric population
• Discuss guidelines to writing research informed consent and assent documents
• Discuss how to adequately review the protocol and source documents, list the documentation needed, discuss how to identify obstacles that may occur and the importance of communication amongst the study teams during study start up
• Discuss special considerations for developing pediatric research study budgets including a review of "hidden costs"
• Discuss monitoring and auditing issues specific to pediatric research
• Discuss the compliance challenges associated with conducting clinical trials and one site’s strategy to address this challenge

Please contact us with any questions or concerns at education@socra.org