November 2024 SOCRA Source Journal - Journal - Page 94
SOCRA Pediatric Clinical Trials Conference
Conducting Clinical Research in the Pediatric Population
IN-PERSON
FEBRUARY 6 & 7, 2025 | SAVANNAH, GA
Workshop Registration Fee: $620 (Non-member $695 - includes one year's membership)
Preconference fee: $175
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the need for continuing education for Clinical
Research Professionals responsible for the activities at pediatric research site. The purpose of this conference is to
assist Research Professionals in improving their skill and their understanding of the responsibilities of conducting
clinical research and clinical trials in the pediatric population.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research
experts professionals. Information will be presented and discussed regarding the administration of clinical research/
trials according to FDA Regulations and International Conference on Harmonisation (ICH) Good Clinical Practice
guidelines for vulnerable populations.
Learning Objectives - The attendee should be able to:
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Discuss the process of submitting an IND/IDE for a pediatric study/trial
Discuss the challenges of off label drug use in the pediatric population
Discuss the consenting/assenting process in pediatric trials
Discuss the role and function of a data safety monitoring board in pediatric clinical trials
Discuss approaches to recruitment in pediatric research
Discuss strategies to retain participants in pediatric trials
Discuss the process for identifying outcome measures in pediatric research studies
Discuss the challenges of long term follow up
Discuss pediatric trial compliance issues and methods of study analysis
Describe the special considerations when developing budgets for pediatric research studies
Discuss the differences between master agreements, work orders, CDAs and CTAs
Discuss best practices for successful contract negotiation
Discuss the critical pathways in pediatric research program planning
Describe how to operationalize clinical research through program management
Discuss how continuous quality improvement is a mechanism for best practices in clinical research
Discuss how to effectively and ef昀椀ciently prepare for monitoring and audit visits
Discuss the importance of self-monitoring
Describe the process of minimizing risk through good clinical research practices
Discuss steps to ensure 昀椀nancial compliance
Discuss the challenges of achieving thorough and compliant record retention
Discuss the requirements for study closeout
SOCRA designates this educational activity for a maximum of 18.0 Continuing Education Credits for SOCRA CE
and Nurse CNE. SOCRA designates this live activity for a maximum of 18.0 AMA PRA Category 1 Credit(s)™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
*Pediatric Research Preconference Workshop - maximum 3.75. Main Conference - maximum 14.25 CE
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council
for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing
education by the American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series: 850
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SOCRA SOURCE © November 2024
