The goal of the training is to provide a refresher on GCP and regulations governing clinical research, as well as an energizing exploration of the importance of ensuring compliance, methods for thinking strategically and critically, and industry trends and best practices. The theme of the training will be to highlight the importance of conducting trials in compliance with the protocol and GCP, improve study coordination, and reduce the risk of inspection findings.
Identify applicable ICH GCP E6 R2 and ISO 14155 guidelines and FDA regulations governing clinical research
Navigate through the requirements governing clinical research using critical thinking skills
Understand what to expect from monitor visits and how to work well with your monitor
Describe best practices for creating and maintaining high quality documentation in research using ALCOA-C
Discuss ‘controversial’ topics in research, such as using notes-to-file, delegation logs and consent notes effectively using well-supported arguments
Understand the mechanics of and how to prepare your site for FDA inspections and Sponsor audits
AGENDA 8:30 am - 4:30 pm
Good Clinical Practice and U.S. FDA Regulations Refresher
FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions
Best Practices for an Effective Site
Human Subject Protection and Informed Consent
High Quality Documentation
Adverse Event Classification and Reporting
Debate Club: Notes-to-File, Delegation Logs, Consent Notes
Understanding Clinical Research Monitoring
How to work well with your monitors
In Person Training - At IMARC or Your Location
7.0 hours (0.7 CEUs)
Intermediate
Experienced
