This session provides a comprehensive overview of the key processes involved in setting up, managing, and maintaining a ClinicalTrials.gov account. With an increasing emphasis on research transparency and regulatory compliance, institutions must navigate complex registration, reporting, and update requirements to ensure adherence to federal and institutional guidelines.
Through insights from research Institutions A & B this session will explore institutional strategies for handling ClinicalTrials.gov compliance, including proactive registration workflows, data integrity checks, and results reporting processes.
Attendees will gain practical knowledge on how to optimize their ClinicalTrials.gov workflows, mitigate compliance risks, and develop institution-wide best practices that support both Principal Investigators (PIs) and administrative teams. The session will also cover common challenges in regulatory compliance, including IRB integration, discrepancies in reporting timelines, and federal enforcement measures.
By the end of this session, attendees will be equipped with actionable strategies to enhance ClinicalTrials.gov efficiency, streamline reporting obligations, and strengthen institutional policies for research transparency.
Learning Objectives:
1. Understand the Fundamentals of ClinicalTrials.gov Compliance:
Gain foundational knowledge on ClinicalTrials.gov registration, update, and reporting requirements, including NIH, FDA, and institutional policies.
2. Explore Institutional Approaches to ClinicalTrials.gov Management:
Learn how institutions such as WCM and URMC manage compliance through centralized tracking systems, training programs, and administrative oversight.
3. Optimize Compliance Workflows for PIs and Research Administrators:
Identify best practices for supporting researchers in meeting registration and reporting deadlines, maintaining data accuracy, and resolving discrepancies.
4. Navigate IRB Integration and Institutional Challenges:
Understand how to align ClinicalTrials.gov requirements with IRB protocols, institutional review processes, and study startup workflows.
5. Develop Strategies for Effective Results Reporting and Escalation Policies:
Learn how to implement internal reporting deadlines, escalation measures, and quality control reviews to prevent noncompliance risks and regulatory delays.
This session will provide valuable insights for research administrators, compliance officers, and PIs involved in managing ClinicalTrials.gov accounts, helping them navigate regulatory requirements efficiently while ensuring research integrity and transparency.
· Introduction & Session Goals
· Understanding ClinicalTrials.gov Compliance
· Institutional Best Practices (WCM & URMC)
· Key Challenges and Solutions
· Optimizing IRB and ClinicalTrials.gov Integration
· Results Reporting and Escalation Policies
· Lessons Learned and Best Practices
· Q&A and Discussion
Content Level: Basic
Track: Clinical and Transnational Research
Speaker(s):
Anita Trupiano, TruResearch Consultants, Huntington
**Elective session for Clinical Trials Research Administration Certificate (CTRA-E)**