Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research

What You Need to Know? 👇

What are the key responsibilities of clinical investigators in medical device studies?

Investigators must supervise device testing, protect subject rights and welfare, control investigational devices, ensure informed consent compliance, and maintain accurate records per 21 CFR 812 requirements.

How should investigators delegate study tasks while maintaining regulatory compliance?

Investigators must ensure delegated staff are qualified by education/training/experience, provide adequate training on protocols, maintain supervision lists, and retain accountability for all delegated activities and regulatory violations.

What constitutes adequate supervision of clinical trial conduct?

Adequate supervision includes routine staff meetings, monitoring oversight, timely problem correction procedures, consent process verification, source data accuracy checks, and medical/ethical issue resolution protocols.

What medical care responsibilities do investigators have toward study subjects?

Investigators must provide reasonable medical care for study-related adverse events, ensure access to qualified practitioners when needed, inform subjects of unrelated medical conditions discovered, and maintain availability throughout the study.

How should investigators handle protocol violations that may compromise subject safety?

Investigators should minimize risks by strict protocol adherence, particularly for inclusion/exclusion criteria and safety assessments. Violations exposing subjects to unreasonable risks constitute failure to protect subject welfare.

What are the specific reporting requirements for medical device investigations?

Investigators must report unanticipated adverse device effects within 10 working days, submit annual progress reports, report protocol deviations within 5 days, and provide final reports within 3 months of study completion.

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What You Need to Do 👇

Recommended Actions

1. Develop a comprehensive supervision plan including:
   • Regular staff meetings
   • Training procedures
   • Quality control checks
   • Safety monitoring procedures
2. Establish delegation procedures:
   • Create delegation log
   • Document qualifications
   • Define roles and responsibilities
   • Ensure proper training
3. Implement subject protection measures:
   • Medical care procedures
   • Emergency contact system
   • Adverse event reporting process
   • Protocol compliance monitoring
4. Create documentation systems for:
   • Training records
   • Study conduct oversight
   • Medical care provision
   • Protocol deviations
   • Safety monitoring
5. Review and update procedures for:
   • Staff supervision
   • Quality control
   • Subject safety
   • Data integrity
   • Regulatory compliance

Key Considerations

Clinical testing

• Investigator must personally conduct or supervise the investigation
• Must ensure adequate medical care for study subjects during trial participation
• Must be available 24/7 for studies with significant safety risks
• Must have procedures for handling medical emergencies
• Must inform subjects’ primary physicians about trial participation (with subject consent)

Human Factors

• Must ensure informed consent is properly obtained
• Must protect rights, safety and welfare of subjects
• Must provide reasonable medical care for study-related adverse events
• Must ensure reasonable access to medical care during the trial

Safety

• Must report adverse events to sponsor
• Must follow protocol to avoid exposing subjects to unreasonable risks
• Must ensure proper oversight of device engineers for medical device studies
• Must maintain adequate safety monitoring procedures

Other considerations

• Must maintain adequate and accurate records
• Must ensure proper delegation of study tasks to qualified personnel
• Must provide adequate training to study staff
• Must supervise all delegated activities
• Must maintain oversight of third parties involved in study conduct
• Must control investigational products

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Relevant Guidances 🔗

• Clinical Investigator Disqualification Procedures and Administrative Actions
• Design Controls for Medical Device Manufacturers
• Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
• IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
• Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies

Related references and norms 📂

• ICH E6: Good Clinical Practice Consolidated Guidance

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Original guidance

• Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
• HTML / PDF
• Issue date: 2009-10-23
• Last changed date: 2019-04-19
• Status: FINAL
• Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Drugs, Biologics, Administrative / Procedural
• ReguVirta ID: 160aa4683366799a2d278038c9867e57