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.
What You Need to Know? 👇
What triggers FDA to initiate disqualification proceedings against a clinical investigator?
FDA initiates disqualification when investigators repeatedly or deliberately violate regulations, submit false information, expose subjects to unreasonable risks, seriously compromise subjects’ rights, or compromise data integrity and reliability.
Can a clinical investigator avoid a formal hearing through a consent agreement?
Yes, investigators can sign a consent agreement at any time during the process, either agreeing to full disqualification or accepting specific restrictions on their use of investigational products.
What happens to ongoing studies when an investigator is disqualified?
FDA evaluates whether studies can continue after removing unreliable data. If remaining data are inadequate for safety conclusions, FDA may terminate the study immediately, especially if public health dangers exist.
Are disqualification proceedings publicly disclosed?
Yes, FDA posts a public listing of investigators who are ineligible, restricted, issued notices, or subject to proceedings. This helps IRBs and sponsors verify investigator compliance status.
Can a disqualified clinical investigator be reinstated?
Yes, disqualified investigators may request reinstatement by providing adequate assurances they will comply with FDA regulations. The Commissioner evaluates these requests following specific agency guidelines for reinstatement.
What is the difference between surveillance and for-cause inspections in disqualification cases?
Surveillance inspections are routine evaluations of investigator practices, while for-cause inspections occur when FDA receives information about potential misconduct. Both can lead to disqualification proceedings if violations are found.
What You Need to Do 👇
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