Clinical Investigator Disqualification Procedures and Administrative Actions
This guidance outlines the administrative process for disqualifying clinical investigators from participating in studies involving investigational new drugs (including biologics) or devices. It applies when FDA determines that an investigator has repeatedly or deliberately violated regulations or submitted false information to sponsors or FDA.
Recommended Actions
- Implement robust quality management system to ensure compliance with FDA regulations
- Maintain accurate and complete documentation of all clinical investigation activities
- Establish procedures for responding to FDA inspections
- Regularly check FDA’s disqualified investigator list when selecting investigators
- Create process for immediate notification to FDA of any significant deviations
- Develop protocol for protecting subject safety if study suspension becomes necessary
- Establish procedures for reviewing and validating data integrity
- Create training program on regulatory requirements for clinical investigators
- Maintain communication channels with IRBs and sponsors regarding compliance issues
- Document all corrective actions taken in response to identified violations
Key Considerations
Clinical testing
- FDA conducts on-site inspections to evaluate compliance with regulations
- Disqualification may occur if:
- Subjects would be exposed to unreasonable risks
- Subjects’ rights would be compromised
- Data integrity is compromised
Safety
- Studies may be terminated immediately if public health danger exists
- FDA may allow continued treatment for subjects if suspension creates life-threatening situations
Other considerations
- Disqualification process includes:
- Notice of Initiation of Disqualification Proceedings (NIDPOE)
- Opportunity for investigator to explain
- Possible consent agreement
- Formal hearing if needed
- Disqualified investigators:
- Cannot receive investigational products
- May affect ongoing studies and approved applications
- May request reinstatement with adequate assurances
- FDA maintains public listing of disqualified investigators
- Criminal proceedings may be initiated separately
Relevant Guidances
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Design Considerations for Medical Device Pivotal Clinical Studies
- Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
Related references and norms
- No specific ISO or industry standards referenced in this guidance
Original guidance
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