Society of Clinical Research Associates (SOCRA) 33rd Annual Conference 2024, 27-29 Sep 2024

Description

The Society of Clinical Research Associates (SOCRA) 33rd Annual Conference 2024 covers topics such as:

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