Safety Monitoring Plan
Given the specific IND safety reporting requirements for the sponsor, drug safety operations and management should be formalized in a sponsor’s Safety Monitoring Plan (SMP) (NCI Guidelines and Further Guidelines for Phase I/IIs) to best be in compliance with FDA, global regulatory requirements and country-specific requirements for pharmacovigilance and risk management.
The SMP should include the policies and procedures for the sponsor to support such monitoring activities and strategic planning and risk management. Monitoring activities such as reviewing safety data (ie. metrics and AEs) and monitoring for possible safety signals and trends (ie. shift tables), reviewing, processing expedited SAE reports and the dissemination of safety reports (to both FDA MedWatch and participant Investigators), and assuring the Investigational brochure is updated as required along with the annual IND study report. Along with support activities, including training, Trial Master File (TMF) documentation, and inspection preparedness.
Risk-based monitoring (RbM) is strategy and plan for clinical studies, to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. A sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical investigator conduct and performance in investigational new drug (IND) studies conducted under 21 CFR part 312 (Guide for Industry Oversight of Clinical Investigators As Risk Based Approach). Modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively (ie. greater use of centralized monitoring methods where appropriate).
Considerations for labeling and packaging of the IND
Along with special guidance and considerations for labeling and packaging: Guide to Safety Considerations for container labels and cartons and FDA Guide to Safety Considerations for Product Design to Minimize Medication Errors and FDA Guide to medication guides and FDA guide to safety labeling changes.
FDAs Communication to the Public and Post marketing Studies
FDA develops and disseminates information to the public about 18 important drug safety issues, including emerging drug safety information, as outlined in the FDA guide to drug safety information FDA communication to the public. A drafted guide update was released in 2012 for comments. Specific guidelines for post-marketing studies are also available: Guide to Post marketing Studies and Clinical Trials and Provising Post Market Periodic Safety Reports.