Two Seattle-area space ventures — Tethers Unlimited and Rocket Propulsion Systems — are among 124 businesses receiving $750,000 Phase II grants from NASA's Small Business Innovation Research program. The two-year grants, announced today, support the further development of technologies that can benefit future space missions as well as life on Earth. All of the recipients, hailing from 31 states in all, received $125,000 Phase I grants during earlier rounds of funding. "We are encouraged by the ingenuity and creativity we’ve seen from these companies in their Phase I work," Jenn Gustetic, NASA's SBIR program executive said in a news release.… Read More

A health economist who has taught on both sides of the border examines the difference between Canada and the United States.

For the first time, researchers have succeeded in creating strong coupling between quantum systems over a greater distance. They accomplished this with a novel method in which a laser loop connects the systems, enabling nearly lossless exchange of information and strong interaction between them. In the scientific journal Science, the physicists from the University of Basel and University of Hanover reported that the new method opens up new possibilities in quantum networks and quantum sensor technology.

In many fish species body size plays an important role in sexual selection. Large individuals are preferred mating partners because they can enhance offspring survival by providing better quality resources than small individuals. While large females and males are often favored by sexual selection, fishing targets and removes these reproductively superior individuals. Academy Research Fellow Silva Uusi-Heikkilä discusses in her recent literature review the implications fisheries selection might have on sexual selection, individual reproductive success and population viability.

Australia's electricity grid operator wants the authority to remotely switch off new rooftop solar systems in SA in order to manage their "invisible and uncontrolled" growth.

Catchpoint delivers world-class Web Performance Monitoring for all Internet services: Website, Mobile, App, Ads, API, DNS, CDN, Streaming, Cloud, & more

BlackLine (NASDAQ: BL) is the worlds most trusted solution for Finance Controls & Automation for delivering powerful real-time automation to accounting & finance teams.

The launch of the renamed, newly independent company follows its acquisition by Altaris Capital Partners.

COVID-19 is having varying effects on different markets within healthcare, with drug delivery systems…

The United States has intervened in a whistleblower suit filed in the District of New Mexico against Community Health Systems Inc. (CHS) and three of its hospitals in New Mexico: Eastern New Mexico Medical Center in Roswell, Mimbres Memorial Hospital in Deming, and Alta Vista Regional Hospital in Las Vegas. The suit alleges that CHS and its three hospitals violated the False Claims Act (FCA) by knowingly causing to be presented to the United States false claims for federal matching Medicaid funds.

The city of Jeffersonville, Ind., has agreed to make extensive improvements to its sewer systems that will significantly reduce the city’s longstanding sewage overflows into the Ohio River in a comprehensive Clean Water Act settlement with federal and state government.

"Today, BAE Systems pleaded guilty to knowingly and willfully making false statements to U.S. government agencies. The actions of BAE Systems impeded U.S. efforts to ensure international trade is free of corruption and to maintain control over sensitive U.S. technology," said Acting Deputy Attorney General Gary G. Grindler.

The department said that today’s settlement will restore competition in voting equipment systems in the U.S. and that, without the divestiture, the acquisition would result in higher prices, lower quality and a reduced incentive to innovate.

The United States has obtained a $10 million consent judgment against Intercare Health Systems Inc., formerly doing business as City of Angels Medical Center, for a Medicare and Medi-Cal fraud scheme in Los Angeles.

A comprehensive settlement has been reached with the City and County of Honolulu that will address Clean Water Act compliance at Honolulu’s wastewater collection and treatment systems.

Cisco Systems and Westcon Group North America (formerly d.b.a. Comstor) have agreed to pay the United States $48 million to settle claims that they made misrepresentations to the General Services Administration (GSA) and other federal agencies in violation of the False Claims Act.

RAE Systems Inc., a publicly-traded U.S. corporation headquartered in San Jose, Calif., has entered into an agreement with the Department of Justice to pay a $1.7 million penalty for violations of the Foreign Corrupt Practices Act.

The city of Evansville, Ind., has agreed to make extensive improvements to its sewer systems that will significantly reduce the city’s longstanding sewage overflows into the Ohio River.

Oracle America Inc. has agreed to pay the United States $46 million to settle claims that Sun Microsystems Inc., a corporation that merged with Oracle in 2010, submitted false claims and caused others to submit false claims to the General Services Administration and other federal agencies.

Iheanyi Frank Chinasa, 39, of Gaithersburg, Md., was convicted yesterday by a federal jury in Richmond, Va., of multiple fraud charges and obstruction of an official proceeding related to his participation in a scheme to defraud Cisco Systems Inc., announced Assistant Attorney General Lanny A. Breuer of the Criminal Division, U.S. Attorney Neil H. MacBride of the Eastern District of Virginia and Michael Morehart, Special Agent in Charge of the FBI Richmond Field Office.

Iheanyi Frank Chinasa, 39, of Gaithersburg, Md., was sentenced today to 84 months in prison for his participation in a scheme to defraud Cisco Systems Inc.

Lawrence R. Marino, a 41-year-old from Goffstown, N.H., pleaded guilty today in federal court to computer intrusion, stemming from his repeated hacks into his former employer’s computer systems.

The Justice Department announced today that it reached a settlement with BAE Systems Ship Repair Inc., a leading provider of ship repair services, to settle allegations that its subsidiary, BAE Systems Southeast Shipyards Alabama LLC, engaged in a pattern or practice of discrimination by imposing unnecessary and additional documentary requirements on work-authorized non-U.S. citizens when establishing their eligibility to work in the United States.

The Justice Department announced today a settlement under the Americans with Disabilities Act (ADA) with Trinity Health Systems to ensure that Trinity Regional Medical Center in Fort Dodge, Iowa, provides effective communication to individuals who are deaf or hard of hearing.

ATK has agreed to pay the United States $21 million in cash and provide necessary in-kind services worth $15,967,160 to fix the 76,000 unsafe para-flares remaining in the government’s inventory. The settlement resolves a False Claims Act suit filed in the U.S. District Court for the District of Utah.

"The Attorney General and I are committed to a criminal justice system and a sentencing policy that are both tough and fair; that deter those contemplating serious criminal conduct and that are guided by research that show when non-incarceration is the best sanction," said Deputy Attorney General Cole.

Data Systems &s Criminal Division and U.S. Attorney for the Eastern District of Virginia Neil H. MacBride.

Ward Diesel Filter Systems Inc. has agreed to pay the United States $628,000 to resolve allegations that it knowingly submitted false claims to federal agencies under a contract to provide diesel exhaust filtering systems for fire engines through the General Services Administration’s (GSA) Multiple Award Schedule program, the Justice Department announced today.

The Unified Government of Wyandotte Co. and Kansas City, Kan., has agreed to a settlement to address unauthorized overflows of untreated raw sewage and to reduce pollution levels in urban stormwater.

General Electric Aviation Systems (GEAS) has agreed to pay $6.58 million to settle allegations that it submitted false claims in connection with multiple Department of Defense contracts.

The Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today that the San Antonio Water System (SAWS) has agreed to make significant upgrades to reduce overflows from its sewer system and pay a $2.6 million civil penalty to resolve Clean Water Act (CWA) violations stemming from illegal discharges of raw sewage. The state of Texas is a co-plaintiff in this case and will receive half of the civil penalty.

The president and chief executive officer of Virginia-based Symplicity Corporation pleaded guilty today to conspiring to hack into the computer systems of two competitors to improve his company’s software development and sales strategy.

The Justice Department reached an agreement today with Commercial Cleaning Systems, a janitorial services company with headquarters in Denver. The agreement resolves claims that the company discriminated against work-authorized non-U.S. citizens in violation of the Immigration and Nationality Act (INA)

And equally important, I want to thank all of you -- the gathered Ministers, Deputy Ministers, Attorneys General, Supreme Court Justices, and criminal legal aid providers and experts -- for participating in this conference. Your presence here epitomizes the dual truths that all free people, wherever they may live, lay valid claim to equality in the eyes of the law, and that the majesty of the law finds its best and highest use in the service of justice.

The Justice Department announced today that Community Health Systems Inc. (CHS), the nation’s largest operator of acute care hospitals, has agreed to pay $98.15 million to resolve multiple lawsuits alleging that the company knowingly billed government health care programs for inpatient services that should have been billed as outpatient or observation services. The settlement also resolves allegations that one of the company’s affiliated hospitals, Laredo Medical Center (LMC), improperly billed the Medicare program for certain inpatient procedures and for services rendered to patients referred in violation of the Physician Self-Referral Law, commonly known as the Stark Law. CHS is based in Franklin, Tennessee, and has 206 affiliated hospitals in 29 states

Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection?

A: Yes, and there’s a simple thing that sponsors and CROs can do to prepare their sites.

This excerpt was lifted from an online, interactive course entitled “Developing a Part 11 Compliance Plan in Clinical Research.” While the course mainly targeted sponsors and CROs, who have the heaviest regulatory burden in this area, sites also have Part 11 and validation concerns, as demonstrated by this question.

Presenter Lisa Olson, a CSV/Part 11 expert with Polaris Compliance Consultants, briefly described her recommendation, which is both simple and effective. (And since that is total catnip to a compliance blogger, I interviewed her after her presentation to develop the following piece.)

So here it is. Here’s what she said...

Clinical research sites rely heavily on technology to store and manage study data, so regulators are focusing on computer systems and electronic data more than ever before. Many of the systems – such as Electronic Data Collection (EDCs), Interactive Response Technology (IRTs), and e-diaries – are selected and largely controlled by sponsors, CROs, and/or third-party vendors. That doesn’t mean, however, that site staff won’t be expected to answer questions about these systems during a regulatory inspection. Quite the contrary: site personnel are responsible for the integrity of the data these systems house. They need to be able to demonstrate the knowledge required to meet their regulatory obligations.

No one is expecting site staff to be computer specialists; the expertise on these systems resides within the sponsor/CRO/vendor organizations. But the better a site can satisfy a basic, frontline inquiry into the systems it uses, the less likely it is that an inspector will pursue additional lines of questions.

So how can sponsors and CROs help?

They can provide a set of short summaries (one page per system) that answer the questions regulators are likely to ask site staff members. Filed in the Investigator Site File (ISF), ready for use, these summaries will be valuable resources.


The Basics

First, sponsors/CROs should supply identifying information: the name of the system, the vendor, the version of the system currently being used, and a few sentences that describe what the system does.
User Access and Control

To ensure both data integrity and compliance with Part 11 e-record/e-signature regulation, it’s essential that access to a system be controlled and data entry/updates be traceable to a specific person. To that end, the one-pager should describe how unique logins are assigned and how users are restricted to activities appropriate to their roles in the study. A monitor requires read-only access to an EDC system. A study coordinator needs to be able to enter and change EDC data. A Principal Investigator must be able to sign electronic Case Report Forms (CRFs). The role determines the access. Staff should also be able to briefly describe how an audit trail captures metadata that show what data were entered/altered, by whom, and when. (And someone, though not everyone, needs to be able to demonstrate how the audit trail can be used to piece together the “story of the data.” That, however, is too much to ask from our one-pager.)

Validation 101

It would be unusual for site personnel to have detailed knowledge of Computer System Validation (CSV) activities. Nevertheless, the one-pager could include a single line that confirms that the system was validated and by whom. A contact number could be included in case a regulator asks for more information or wants to see validation documents.

Where’s The Data?

Regulators will often ask where system data are stored. The answer to that question can be a simple sentence: The data are hosted by the EDC vendor at such-and-such location, or stored at the CRO, or sit on a local server within the site’s IT department.

Finally, the last line of our one-pager could be a simple statement prepared by the sponsor, CRO, or vendor, confirming that the data are protected wherever they are being stored. The data center is secure and environmentally controlled; the data are backed up to protect against loss; the system is accessed via the web through an encrypted channel -- whatever protections apply.

Conclusion

Regulators are increasingly focused on the integrity of study-related data, and that means added scrutiny of electronic systems and records. More inspections are being conducted mid-study so regulators can evaluate and ask about live systems in current operation. It’s very difficult for sites to field these questions without help from the organizations who make the decisions and have the expertise.

It’s okay to tell an inspector, “I don’t know.” (And it’s always preferable to admit that than to improvise an answer.) But say it too many times, and it casts doubt on a site’s ability to produce and maintain reliable study data. That’s in no one’s interest.

It shouldn’t be overly burdensome to develop a one-page summary sheet for each system so site personnel can address an inspector’s questions on the spot. The Investigator Meetings or Site Initiation Visits would be a good opportunity for sites to raise this point with their sponsors/CROs.

Lisa Olson will be giving an encore presentation of “Developing a Part 11 Compliance Plan in Clinical Research,” on March 24th. She describes all the elements that regulators and clients will be expecting, and since sponsors and CROs can’t implement everything all at once, Lisa prioritizes the activities necessary for developing your plan. You can register for the online course, sponsored by the Life Science Training Institute, here. Use the promotion code olson to receive a 10% discount.

As cases of coronavirus (COVID-19) in the United States rise, more and more states have adopted shelter-in-place orders to curtail the pandemic. The disruption to most Americans’ daily lives has been drastic and sudden—and perhaps one of the most dramatic shifts was education’s move to a virtual setting. Even before the current pandemic forced school closures,…

To be capable of surveilling, preventing, and managing disease outbreaks, public health systems require trustworthy, community-embedded public health workers who are empowered to undertake their tasks as professionals. The world has not invested in this cadre of health workers, despite the lessons from Ebola. In a new paper, my co-authors and I discuss why, and…

To be capable of surveilling, preventing, and managing disease outbreaks, public health systems require trustworthy, community-embedded public health workers who are empowered to undertake their tasks as professionals. The world has not invested in this cadre of health workers, despite the lessons from Ebola. In a new paper, my co-authors and I discuss why, and…

John Hudak argues for reforming personnel data systems – more carefully tracking both appointments and vacancies within government offices ­– in order to ensure that agency efficacy is not compromised. Hudak recommends several revisions that would immediately recognize vacancies, track government positions and personnel more carefully, and eliminate long-standing vacancies that reduce the efficiency within a department or agency. He asks Congress to stop its cries of “waste” and “inefficiency” and instead push data system improvements that will limit these issues.

The COVID-19 pandemic has caused a historic spike in unemployment insurance claims, and there is growing consensus that the economy is headed for a potentially deep and protracted recession. In the past, postsecondary credentials or degrees have helped mitigate the impact of an economic downturn. Of all new jobs created after the Great Recession, 99%…

To be capable of surveilling, preventing, and managing disease outbreaks, public health systems require trustworthy, community-embedded public health workers who are empowered to undertake their tasks as professionals. The world has not invested in this cadre of health workers, despite the lessons from Ebola. In a new paper, my co-authors and I discuss why, and…

The New York subway, The Los Angeles Metro, and more ranked by someone who travels a lot but never drives.