Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events
Burdened by excessive, “just in case” safety reports? They’re hurting everyone: sponsors, trial sites, the FDA … and, ultimately, patients, as the resulting backlog can make it harder for the agency to take action to protect the public.
While the FDA determines whether more guidance, clarification or enforcement action will fix this, there is something simple you can do: order Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events.
What recourse do sites have if a sponsor is inundating them with unnecessary reports? Can they set limits on what reports they will review without running afoul of the FDA or their IRBs? Can they get sponsors to compensate them for the extra workload? This report answers all of these questions and more.
Sites and sponsors must be clear on the agency’s rules and expectations, acknowledge the effect of overreporting on trials and formulate answers to correct the problem. Do this and you can save time and money, streamline your processes, have an easier time with the FDA and help reverse the bottleneck. You can do this with the usable information you’ll get in Safety Reporting Overload in Clinical Trials.
- FDA reporting requirements and guidance
- Criteria for reporting to the FDA
- Key definitions and reporting timelines
- How sites can seek reimbursement from sponsors for excessive reports
- How to use a safety assessment committee to evaluate adverse events
- FDA’s efforts to harmonize its safety reporting requirements with other regulators
- Global reporting requirements and processes
Bonus: Features candid opinions from top FDA officials about where the concerns lie, what the impact is and what you can do about it; and input from representatives of sites and trial services organizations who have weighed in with perspectives and examples of successful approaches to lifting the burden.
Understand and take steps to solve your overreporting-related issues with Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events.
About the Contributors
A variety of agency and industry experts contributed to this report, including:
Elena Jouravleva, PhD
Who Will Benefit
- Sponsor research and development staff
- Sponsor clinical operations staff
- Safety-reporting and complaint-handling personnel
- Regulatory affairs at both sponsors and sites
- Research center directors
- Clinical Research Associates (CRAs)
- Clinical Research Coordinators (CRCs)
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