SOCRA CCRP Practice Exam

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What is issued by the FDA if an investigator may be disqualified due to noncompliance?

Certificate of Noncompliance
Notice of Compliance
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain
Warning of Potential Disqualification

The correct answer is: Notice of Initiation of Disqualification Proceedings and Opportunity to Explain

The Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) is issued by the FDA when an investigator may be disqualified due to noncompliance. The other options are incorrect because - A Certificate of Noncompliance is not issued by the FDA, it is a term used in the clinical trials industry - A Notice of Compliance is typically issued to a new drug or medical device that has been approved by the FDA, it is not related to investigator noncompliance - A Warning of Potential Disqualification is also not issued by the FDA, it is not a formal notice or action taken by the agency in regards to investigator noncompliance.