Society of Clinical Research Associates (SOCRA) 35th Annual Conference 2026

Key Topics

• FDA audit findings and best practices to avoid common pitfalls
• Recent changes to the Common Rule (45 CFR 46)
• How Trial Master File quality can improve site efficiency and effectiveness
• Strategies for quality assurance program development
• Remote monitoring best practices
• The use and benefits of centralized monitoring
• The regulatory and quality parameters of electronic data records
• Adverse event recognition and reporting
• How researchers can renew their emphasis on protections beyond the regulations
• The FDA guidelines for e-consent
• How to successfully implement and use risk based audit programs
• The role and importance of the project manager in clinical research
• Best practices for using e-consent and passing IRB approval
• How tools and strategies that can produce a proactive stance on the responsible conduct of research
• Best practices to avoid common errors in pediatric research
• Techniques to overcome health disparities in research populations
• The process and challenges of expanded access programs
• The regulatory requirements to start and conduct a sponsor-investigator IND trial
• Proven and effective strategies for patient recruitment and retention
• Health Canadas Clinical Trial Compliance Program
• Common issues in multi-national research
• The benefits of self auditing programs
• Best practices for developing market adoption evidence for device studies
• Risk determination in device studies
• Best practices for coding for clinical trials
• Clinical research budget development and negotiation
• Best practice for clinical investigator site source documentation

Who should Attend

Clinical research professionals including:

• Research coordinators
• Investigators
• Project managers
• Research associates
• Educators
• Consultants
• Administrators