Clinical Research Studies During the COVID-19 Pandemic Public Health Emergency

Corona Virus Molecule Rendering Public Health Crisis

Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies

By: Jennifer Goldfarb – MSN, RN, CCRP

As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50 states and 210 countries throughout the world. Clinical Research is a delicate ecosystem within healthcare that can be easily advocated for as an essential healthcare service. It is a highly complex, intensely regulated and regimented, environment. It is a critical component of healthcare that drives scientific and medical advances to promote health and treat illness. This environment has suffered unprecedented disruption and chaos during this pandemic. While people hunker down in their homes, waiting for this storm to pass, clinical research conduct is being adapted, paused, and even discontinued, in every therapeutic area.

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Digital Tools for Billing Compliance

By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC
Kelly Willenberg & Associates

Abstract: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. This article describes digital tools that clinical research professionals already have that they can use to facilitate billing compliance as well as the benefits and challenges of each tool. Clinical research professionals must determine which tools will be most effective at their site.

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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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An Overview of the General Data Protection Regulation (“GDPR”) for Clinical Research Organizations

James F. Bush, Esq. [1]

Abstract

In 2018, the European Union’s General Data Protection Regulation (“GDPR”) came into full force and effect. With the growth of international multi-center clinical research studies, U.S.-based research organizations and investigators will now be governed by the GDPR to the extent that they control or process Personal Data of EU citizens in the course of their research. While efforts to attain compliance with HIPAA and HITECH within the U.S. provide clinical researchers a head-start in attaining compliance with the GDPR, substantial additional efforts must be undertaken to avoid the risk of enforcement penalties for failure to meet the mandates of the GDPR in conducting clinical research. A basic understanding of the important rights granted to study subjects, the jurisdictional reach of the law, logistical and organizational considerations, and the possible risks of enforcement action is now an essential competency for those engaging in clinical research involving EU citizens. The goal of this paper is to provide a regulatory overview of the law and its effect on clinical research in order to enhance the competency of investigators, project managers, and decision-makers involved in such clinical research.

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