Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
This guidance clarifies the responsibilities of investigators conducting clinical investigations of drugs, biological products, or medical devices, focusing on protecting human subjects' rights, safety, and welfare, and ensuring data integrity. It specifically addresses supervision of study conduct and subject protection requirements.
Recommended Actions
- Develop a comprehensive supervision plan including:
- Regular staff meetings
- Training procedures
- Quality control checks
- Safety monitoring procedures
- Establish delegation procedures:
- Create delegation log
- Document qualifications
- Define roles and responsibilities
- Ensure proper training
- Implement subject protection measures:
- Medical care procedures
- Emergency contact system
- Adverse event reporting process
- Protocol compliance monitoring
- Create documentation systems for:
- Training records
- Study conduct oversight
- Medical care provision
- Protocol deviations
- Safety monitoring
- 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
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
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 summary file ID: 160aa4683366799a2d278038c9867e57
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