Claude Arthur Verbal II, formerly of Raleigh, North Carolina, and now of Miami, was sentenced today to serve 135 months in prison for tax fraud, healthcare fraud and money laundering crimes in two separate cases in federal court

Benjamin Pierce Bishop, 60, a former Honolulu, Hawaii, civilian defense contractor and retired lieutenant colonel in the U.S. Army, was sentenced today by U.S. District Judge Leslie E. Kobayashi to serve 87 months imprisonment and three years’ supervised release for willfully communicating classified national defense information to a person not authorized to receive it and unlawfully retaining classified national defense information at his home.

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction

The former owner and operator of three medical clinics located in Los Angeles was sentenced today to 78 months in prison for his role in a scheme that submitted more than $4

A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

These are exciting times for Vapotherm Inc. (VAPO) whose share price has almost doubled in value since the beginning of this year.

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

__________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

by Justin Elliott, Paul Kiel and Lydia DePillis

Through programs like the Small Business Administration’s Paycheck Protection Program and the Federal Reserve’s Main Street Lending Program, the federal government is deploying hundreds of billions of dollars in grants, loans and bond purchases to help businesses amid the coronavirus-sparked economic crisis. Each program comes with different strings, but their basic purpose is to keep workers on the payroll.

We want to know what this means for your workplace. How has your company treated its workers during the crisis? Have you or your colleagues been laid off, furloughed or otherwise affected? Have you seen money used in surprising ways? What do you think we should be reporting on?

We are the only ones reading what you submit. If you would prefer to use an encrypted app, here is what we suggest. Send questions to bailout@propublica.org.

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Neurological symptoms are common in patients with COVID-19, particularly if they have a severe infection, research published in JAMA Neurology suggests.

To read the whole article click on the headline

Venture capital firm Frazier Healthcare has grabbed Scott Byrd, Ian Mills, and Gordon McMurray as its new Entrepreneur-in-Residence consultants.

A recent study looking at the effects of caffeine on brief, high intensity exercise found the substance improved performance, regardless of genetic variations in how subjects metabolized caffeine.

In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.

For goodness sake, if you're going to hike, wear a mask.

The repo rate has been reduced by 75 basis points from 5.15 percent to 4.4 percent.

The company is further looking to raise Rs 250 crore in the next few quarters. 

The post India Deal Monitor: MYSUN snags about $4.3m funding and more updates appeared first on DealStreetAsia.

The funding will be used to spruce up technology and expand product offerings.

The post India Deal Monitor: RTP Global leads $9m funding in Classplus and more updates appeared first on DealStreetAsia.

Exfinity Ventures and IAN Fund led the funding in Vernacular.ai.

The post India Deal Monitor: Vernacular.ai raises $5.1m in Series A round and more updates appeared first on DealStreetAsia.

Apr 21, 2020

Stephen Walt argues that as democracies falter, it's worth considering whether the United States made the right call in attempting to create a liberal world order.

Apr 21, 2020

Stephen Walt argues that as democracies falter, it's worth considering whether the United States made the right call in attempting to create a liberal world order.

Apr 21, 2020

Stephen Walt argues that as democracies falter, it's worth considering whether the United States made the right call in attempting to create a liberal world order.

Mar 31, 2020

A nuclear explosion detonated anywhere by a terrorist group would be a global humanitarian, economic, and political catastrophe. The current COVID-19 pandemic reminds us not to ignore prevention of and preparation for low-probability, high-consequence disasters. For nuclear terrorism, while preparation is important, prevention must be the top priority. The most effective strategy for keeping nuclear weapons out of the hands of terrorists is to ensure that nuclear materials and facilities around the world have strong and sustainable security. Every president for more than two decades has made strengthening nuclear security around the globe a priority. This includes the Trump administration, whose 2018 Nuclear Posture Review states: “[n]uclear terrorism remains among the most significant threats to the security of the United States, allies, and partners.”

Apr 21, 2020

Stephen Walt argues that as democracies falter, it's worth considering whether the United States made the right call in attempting to create a liberal world order.

Apr 21, 2020

Stephen Walt argues that as democracies falter, it's worth considering whether the United States made the right call in attempting to create a liberal world order.