Your friends from the FDA stopped by and noted several red flags at your site in Form 483. Now what? The most important thing you can do as a principal investigator is accept responsibility for these violations and demonstrate you’re taking steps to address them.
As a leading CRO, principal investigators often ask us how to prevent these issues
and respond to citations when they do occur. IMARC Research has created a new whitepaper that offers an overview of:
- The most common deficiencies cited in Form 483s
- What to do if your site receives one
- How to avoid Form 483 citations
If you start a new study with the end in mind, prospectively plan to conduct a well-controlled study in order to avoid the commonly encountered pitfalls that whitepaper addresses. Employ critical thinking and creative problem-solving skills to address and correct commonly encountered issues in study conduct.
We encourage you to download our new whitepaper and use for future reference.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
