Maintaining Compliance of Clinical Sites with Regards to the FDA Draft Guidance on (Risk-Based Approach to Monitoring)
Overview:
Monitoring of clinical sites is a critical part of the Good Clinical Practices. With the advent of electronic data capture (EDC processes and more recently the FDA guidance, Oversight of Clinical Investigations-a Risk-based Approach to Monitoring some changes in the way we monitor sites and the data collection are taking place.
Clinical sites need to be prepared for increased scrutiny and understand the changes taking place. Many if not most clinical sites are now familiar with GCP and with EDC processes to input data or to answer queries, but have a much poorer familiarity of how to maintain compliance with all the requirements specified in the regulations or in study-specific documents and thus how is that information to be monitored.
The clinical team needs to develop processes that will provide methods for monitoring data and compliance, communicate this information to the team, inform the clinical sites of the expectation, and fully implement the techniques and processes defined. Bottom line is to identify potential areas of non-compliance early and establish procedures that either prevent them from happening or establish contingency plans to deal with high risk sites and high risk data.
Why you should attend:
The FDA is removing the old guidance document on monitoring and recommending changes that conflict with conventional Good Clinical Practices (GCP) that have been in place since the ICHE6 guidelines had been issued. What that means is more of the clinical team needs to be involved with monitoring the sites and the sites need to document compliance by additional means beyond source documentation.
The routine monitoring of the sites would now goes beyond the CRA going to the site but also involves Project Managers, data management, statistics, medical monitoring, pharmacovigilance, and lab and IMP management.
Sites need to know how the monitoring will change when and what they have to do (and when) to demonstrate compliance with the protocol, safety evaluations and assessments, data entry, and laboratory collection and assessments. Site-specific and study-specific documents such as Study Operations Manuals and monitoring plans should be changed to address the changes in monitoring. Project managers need metrics to assess when risk-based monitoring provides signals that could indicate changes in oversight may be needed to maintain data integrity and patient safety.
Areas Covered in the Session:
- Summary of guidance document: Oversight of Clinical Investigations-a Risk-based Approach to Monitoring
- Preplanning for high risk monitoring
- Roles of different clinical team members (e.g. project manager, clinical research associates, data management, biostatistics, clinical site coordinator, principle investigators, clinical trial associate)
- Documentation (e.g. process and process maps, monitoring plans, monitoring reports, issue escalation)
Who Will Benefit:
- Site Clinical Coordinators
- Site Managers
- Clinical Operations
- Project Managers
- Clinical Research Associates
- Clinical Trial Associates
- Medical Monitors
- Pharmacovigilance specialists
- Principle Investigators