Your friends from the FDA stopped by and noted several red flags at your site in a 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.
- 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.