This post is sponsored by IMARC Research, Inc.
Compliance with the Federal Regulations, Agreements with the Sponsor, Investigational Plan, and Requirements of the IRB play a vital role in the FDA approval process. Effective training of the study team is a key component to a site’s overall success and compliance. No matter the “sport” (device or drug), “position” on the team (sponsor, investigator, monitor or coordinator) everyone is working toward FDA approval. A true victory!
When focusing on site compliance, there are many factors to consider. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities. The research coordinator carries out many of the day-to-day activities and touches nearly every study milestone. With a focus on training and the research coordinator, this whitepaper will piece these two key factors together to give an overall picture of study compliance at the site level.
Please take time to download IMARC Research’s newest whitepaper.