Risk-Based Monitoring in Clinical Investigations of Medical Products
This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of medical products (drugs, biologics, medical devices, and combinations). It aims to enhance human subject protection and data quality by focusing oversight on critical aspects of study conduct and reporting.
What You Need to Know? 👇
What is risk-based monitoring and how does it differ from traditional monitoring approaches?
Risk-based monitoring is a tailored approach that focuses oversight activities on preventing or mitigating important and likely risks to critical data and processes necessary for human subject protection and trial integrity, rather than routine comprehensive monitoring of all data.
Can centralized monitoring replace on-site monitoring visits entirely?
While centralized monitoring can supplement or reduce on-site monitoring frequency, FDA recommends a combination approach. Complete reliance on centralized monitoring should only occur in exceptional circumstances, with monitoring plans identifying when on-site visits would be indicated.
What are considered critical data and processes that must be monitored?
Critical elements include informed consent verification, protocol eligibility criteria adherence, investigational product accountability, study endpoint procedures, protocol-required safety assessments, serious adverse event documentation, and procedures essential to trial integrity like maintaining study blind.
How should sponsors document their risk-based monitoring activities?
Documentation should include the date and personnel involved, summary of data/activities reviewed, description of any noncompliance or deficiencies identified, actions taken or recommended, responsible persons, and completion dates. Sufficient detail must allow verification that the monitoring plan was followed.
What factors should influence the intensity and frequency of monitoring activities?
Key factors include study design complexity, endpoint types, clinical complexity of study population, geography, investigator experience, electronic data capture use, investigational product safety profile, study stage, and quantity of data collected.
Are there specific requirements for monitoring plan development and content?
Yes, monitoring plans should describe monitoring methods, timing and frequency criteria, specific activities for each method, trigger events for plan changes, communication processes, noncompliance management, quality assurance measures, and amendment procedures for plan updates.
What You Need to Do 👇
Recommended Actions
- Develop a risk-based monitoring plan tailored to the specific trial
- Identify critical data and processes that require monitoring
- Perform risk assessment to determine monitoring approach
- Implement mix of centralized and on-site monitoring as appropriate
- Document monitoring activities thoroughly
- Establish clear communication processes
- Provide adequate training for monitoring personnel
- Create procedures for addressing noncompliance
- Regularly evaluate monitoring effectiveness
- Update monitoring plan as needed based on findings
Key Considerations
Clinical testing
- Focus monitoring on critical data and processes necessary for human subject protection and trial integrity
- Identify critical data and processes prospectively
- Perform risk assessment to identify and understand risks that could affect critical data collection
- Develop monitoring plan focused on important and likely risks
Human Factors
- Verify informed consent was obtained appropriately
- Consider human subject protection when determining monitoring approach
- Ensure appropriate protection for seriously ill or vulnerable populations
Software
- Consider EDC capabilities for assessing quality metrics in real-time
- Utilize electronic systems for centralized monitoring where possible
- Ensure processes for timely data entry and access to electronic records
Safety
- Monitor protocol-required safety assessments
- Document and report serious adverse events and unanticipated adverse device effects
- Consider product safety profile when determining monitoring intensity
Other considerations
- Use mix of centralized and on-site monitoring practices
- Document monitoring activities with sufficient detail
- Ensure proper training of monitoring personnel
- Establish communication processes for monitoring results
- Have processes for addressing noncompliance
- Consider protocol and CRF design impact on quality
Relevant Guidances 🔗
- Design Controls for Medical Device Manufacturers
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms 📂
- ICH E6: Good Clinical Practice: Consolidated Guidance
- ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good clinical practice
- ISO 31010:2009: Risk Management – Risk Assessment Techniques
Original guidance
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- HTML / PDF
- Issue date: 2013-08-07
- Last changed date: 2024-11-14
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Investigation & Enforcement, Drugs, Biologics, Administrative / Procedural
- ReguVirta ID: 123a8bf484021531b7c5e9c267f0653f