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 ethical considerations when conducting clinical research in the pediatric population
  • Discuss ways in which sites can improve engagement for families by defining tactics to educate and promote research participation
  • Discuss guidelines to writing research informed consent and assent documents
  • Discuss ways a research nurse can review a protocol for feasibility and help to set reasonable expectations for the potential patient population
  • Discuss the pediatric drug development process from an industry perspective
  • 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
  • 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 role and importance for external monitoring and methods safety issues are identified and managed during drug development and post marketing of new medications
  • Discuss the compliance challenges associated with conducting clinical trials and one site’s strategy to address this challenge
  • Discuss the potential role of pediatric clinical research networks in accelerating the development of pediatric therapeutics