This course provides a refresher and additional training for the experienced clinical research coordinator (CRC). We will start with a refresher on GCP and the key regulations and guidelines governing medical device clinical research. Then we will explore the importance of good study management and documentation, industry trends and best practices at the research site. We will also cover inspection preparation, as well as CAPA planning and implementation.
Identify applicable ICH GCP E6 R2 and ISO 14155 guidelines and FDA regulations governing clinical research
Explore ‘controversial’ topics in research, such as using notes-to-file, delegation logs and consent notes effectively using well-supported arguments
Discuss study management and best practices for securing compliance in device studies
Understand the mechanics of FDA inspections and describe at least three (3) recommendations to help sites and sponsors be inspection ready.
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
Securing Compliance in Device Studies: Effective Study Management
Best Practices: Informed Consent, Adverse Event Managing and Reporting, and Maintaining Study Documentation
Protocol Deviations: Identifying, Documenting and Reporting
Corrective and Preventative Action Plans: Identifying, Documenting and Implementing to Improve Site Compliance
Debate Club: Notes-to-File, Delegation Logs, Consent Notes
Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites
Clinical Research Coordinators, nurse coordinator, site manager, or investigator with solid background in FDA and GCP
Staff involved in or manages daily operation of clinical research at a trial site
In Person Training - At IMARC or Your Location
7.0 hours (0.7 CEUs)
Intermediate
Experienced
