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 legislative, regulatory and international efforts facilitating drug/device development
  • Discuss challenges when conducting research in the pediatric critical care environment
  • Discuss best practices used to engage the NICU staff in conducting and managing clinical trials
  • Discuss special considerations for developing pediatric research study budgets including a review of "hidden costs"
  • Discuss the current state of the workforce including the Great Resignation