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FDA and Site Perspectives on Overreporting of Adverse Events Management Report

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FALLS CHURCH, Va. (PRWEB)

Safety Reporting Overload in Clinical Trials:

FDA and Site Perspectives on Overreporting of Adverse Events

https://www.centerwatch.com/products/564

Overreporting, sending in unnecessary safety reports “just in case”, hurts everyone: sponsors, trial sites and the FDA. Ultimately, it hurts 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 that can be done: order Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events.

This report provides information for sites and sponsors to be clear on the agency’s rules and expectations. But also acknowledges the effect of overreporting on trials and formulate answers to correct the problem. Do this and save time and money, streamline the process, have an easier time with the FDA and help reverse the bottleneck. All this can be done with usable information found in this report:


  • 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 can be done 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 overreporting-related issues with Safety Reporting Overload in Clinical Trials: FDA and Site Perspectives on Overreporting of Adverse Events.

Management Report Details:

Safety Reporting Overload in Clinical Trials:

FDA and Site Perspectives on Overreporting of Adverse Events

https://www.centerwatch.com/products/564

Price:

$397

Easy Ways to Order:

Online: https://www.centerwatch.com/products/564

By phone: 888.838.5578 or 703.538.7600

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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