Evaluating an Investigator’s Qualifications

Research related to COVID-19 has increased awareness in the community about the role of the institutional review board (IRBs) to protect the rights and welfare of research participants.  The regulations and guidelines in place to ensure the safety of research participants cover a wide range of areas that need attention.  In addition to evaluating a […]

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Addressing Burnout Among Clinical Research Staff

In March 2019, we published an article addressing the threat of burnout among clinical research coordinators. A year later, research centers were scrambling to close amid lockdowns. Clinical trials were paused as resources shifted to caring for the surge of patients with COVID-19 in hospitals. Health care providers, including clinical research professionals, were thrust into […]

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When an Investigator is also a Sponsor

When investigators embark on designing, writing, and initiating the clinical trial, their responsibilities are just beginning. The FDA calls these investigators “sponsor-investigators (SIs)”. A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. In other words, in an investigator-initiated trial, the […]

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Identifying Social Determinants in Clinical Trial Screening

Social determinants of health (SDoH) are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes. Collectively, they contribute significantly “to the social patterning of health, disease, and illness,” according to the CDC. Examples of these social determinants include safe and affordable […]

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Be Prepared for an FDA Audit

An FDA audit or inspection can occur at any time, and sometimes with very little advance warning. The FDA conducts both announced and unannounced inspections of clinical investigator sites, typically under the following circumstances: to verify the accuracy and reliability of data that has been submitted to the agency; as a result of a complaint […]

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Fair Market Value

One of the most critical first steps in preparing to launch a clinical trial is the development of a budget that covers expenses and compensates the research site. The budgeting process can be complex and requires detailed review of the protocol and a methodical line-by-line attention to detail. A properly negotiated budget ensures that a […]

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Proposed Cures 2.0 Act May Have Implications for Researchers

Members of the U.S. House of Representatives have introduced updates to the 21st Century Cures Act, which was signed into law in December 2016. The proposed legislation coincides with a detailed concept paper the White House published Tuesday in Science Magazine outlining their vision for the new research agency. The 21st Century Cures Act, known as “Cures”, was […]

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Clinical Trials: virtual, remote, or decentralized?

What does it mean to conduct a virtual clinical trial? What about remote, decentralized, hybrid, or siteless studies?  These terms are sometimes used interchangeably. But there may be value in distinguishing how these models can facilitate recruiting subjects and change the way clinical trials have traditionally been conducted. Advances in mobile and digital health technologies […]

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Restarting Research Projects and Programs

The COVID-19 pandemic had significant impacts on clinical trials and research programs. According to researchers at Penn State, over 80 percent of clinical trials were suspended between March 1 and April 26, 2020, mostly due to the pandemic. The impact was more substantial for government or academic-funded studies than for sponsored trials, according to their […]

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A Methodological Approach to Coverage Analysis

To ensure appropriate reimbursement for the services provided to a patient in a clinical trial, research sites must develop a budget for each study. One important step in developing a clinical trial budget is conducting a “coverage analysis,” also known as Medicare Coverage Analysis, sometimes referred to an MCA. An MCA identifies the services for […]

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