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A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance.
Effective remote monitoring plans enable sites and sponsors to maintain trial participant safety, data quality, and data integrity. With limited availability to access research sites in person over the past year, sponsors and monitors rapidly changed how they review study procedures, subject status, and study progress at research sites.
With comprehensive research portfolios and a myriad of operational challenges to manage, it has never been more important for sites to approach research operations as a business.
The SARS-CoV-2 pandemic has impacted all aspects of society. Various government and private groups around the world are endeavoring to develop safe and effective vaccines at an unprecedented pace and scale to quell the pandemic as quickly as possible.
Over the past year, clinical research professionals have faced unprecedented challenges related to both the clinical and operational management of their research. Maintaining regulatory compliance and visibility within an increasingly remote environment has been a key focus area for many institutions.
FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.
In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues involved in paying research subjects.
Billing compliance is an essential part of clinical trial participation, and this is especially important for high-cost services such as CT scans, PET scans, nuclear medicine, and MRIs. However, organizations ...
Throughout the COVID-19 pandemic, research institutions have addressed a wide array of challenges to keep research moving. As we look forward, many institutions still have unanswered questions on how to ...