Program Description

Pediatric Clinical Trials Conference

Goal: 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. The purpose of this workshop is to assist Research Professionals in improving their skills and their understanding of the responsibilities of conducting clinical research in the pediatric population.

This conference provides attendees with new information, management tools, and real life examples, to help participants navigate the evolving landscape of pediatric research.

Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding the administration of clinical trials according to FDA Regulations and International Council on Harmonisation (ICH) guidance regarding vulnerable populations in clinical research.

Learning Objectives: Upon completion of this (full) course the attendee should be able to:

  • Discuss the unique challenges of conducting clinical trials in a pediatric setting
  • Discuss the challenges of off label use in the pediatric population
  • Discuss the consenting process in pediatric trials
  • Discuss the unique regulatory requirements for pediatric trials
  • Discuss the role and function of a data safety monitoring board in pediatric clinical trials
  • Discuss key metrics and the factors that influence study complexity and workload
  • Describe how to operationalize clinical research through program management
  • Discuss the critical pathways in pediatric research program planning
  • Discuss the challenges of pediatric research in different therapeutic areas
  • Discuss the goals of the Global Pediatric Clinical Trials Network
  • Discuss how to effectively and efficiently prepare for monitoring and audit visits
  • Discuss the importance of self-monitoring
  • Describe the special considerations when developing budgets for pediatric research studies
  • Discuss approaches to recruitment in pediatric research
  • Discuss strategies to retain pediatric participants
  • Discuss the challenges of long term follow up in pediatric clinical trials
  • Discuss when an IND or IDE application is required and expanded access regulations for pediatric research
  • Describe the process of minimizing risk through good clinical practices
  • Discuss the process for identifying outcome measures in pediatric research studies