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FDA Inspections of Clinical Investigators: Are You Ready?

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White Paper 1 FDA Inspections of Clinical Investigations: Are You Ready? Life science companies are developing cutting-edge medicines, medical devices, and therapies that entail increasingly complex clinical trials. As a result, regulators throughout the world have to step up their vigilance in overseeing clinical trials to ensure the safety of participants and the integrity of clinical research. In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to strengthen its oversight of clinical investigators and clinical trials. In Europe, tougher regulations for medical devices are being proposed by the European Commission, including stricter rules for notified bodies that conduct inspections during clinical trials. The increased focus on clinical trials means sponsors and CROs can expect more stringent (if not more frequent) inspections. If your company is sponsoring a clinical trial or if it's a CRO conducting research on behalf of a sponsor, are you ready for an inspection? Types of Inspections In general, life science companies undergo or participate in any or all of these inspections: first-party inspection (conducted internally by a company); second- party inspection (conducted by a customer); and third-party inspection (conducted by regulatory agencies such as the FDA or notified bodies in Europe). This white paper will discuss inspections conducted by: • Regulatory bodies auditing CROs and organizations conducting clinical trials; and • Sponsors auditing CROs that are conducting clinical trials on their behalf. FDA's Concerns in Clinical Research There are two major regulatory concerns in clinical research: patient safety and data integrity. Existing regulatory requirements almost always stem from those concerns. In the U.S., the FDA finalized a guidance in August 2013 called "Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring." 1 It signaled the agency's intention to maximize its oversight of clinical trials. The guidance encourages the industry to use risk-based approach in monitoring clinical trials, as well as wider use of alternative monitoring approaches. In addition, the following FDA guidances are an important part of the agency's effort to protect clinical trial patients and ensure the quality of clinical research data:

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