A public service announcement (PSA) featuring Attorney General Eric Holder began airing this week on the Investigation Discovery network.

A federal court has permanently barred Charles Klink, Caleb Grodsky and Steven Block from promoting abusive tax shelters known as “intermediary transactions” and “distressed asset trusts.”

Javier A. Diaz Castro, 30, was convicted on Dec. 12, 2011, of two counts of conspiracy to possess with intent to distribute more than five kilograms of cocaine, two counts of attempting to possess with the intent to distribute more than five kilograms of cocaine, and two counts of possession of a firearm in furtherance of a drug transaction.

Ricardo Amaro-Santiago, 39, was convicted of conspiracy to possess with intent to distribute more than five kilograms of cocaine, attempting to possess with the intent to distribute more than five kilograms of cocaine and possession of a firearm in furtherance of a drug transaction.

"The auto parts investigation is the largest criminal investigation the Antitrust Division has ever pursued, both in terms of its scope and the potential volume of commerce affected by the alleged illegal conduct," said Acting Assistant Attorney General Pozen.

The U.S. District Court for the Eastern District of Washington has entered a consent decree against Dominguez Foods of Washington Inc. to resolve a food seizure action alleging violations of the Food, Drug and Cosmetic Act (FDCA), the Justice Department announced today.

"This announcement underscores the bold, innovative and coordinated ways in which we are working alongside authorities at every level to prevent, identify and prosecute health care fraud throughout the country," said Deputy Attorney General Cole.

"In Dallas, and the eight other Strike Force cities, the Criminal Division and our partners in the U.S. Attorneys’ Offices will continue to crack down on Medicare fraud and hold accountable those stealing from the public fisc," said Assistant Attorney General Breuer.

Arcadio Hernandez-Soto, 35, was convicted in San Juan of three counts of conspiracy to possess with intent to distribute more than five kilograms of cocaine, four counts of attempting to possess with the intent to distribute more than five kilograms of cocaine and four counts of possession of a firearm in furtherance of a drug transaction.

Three men, including a former officer with the Puerto Rico Department of Corrections, were convicted by a federal jury in San Juan, Puerto Rico, yesterday for their roles in providing security for drug transactions.

"Although 44 years have passed since our nation first mourned the loss of Dr. King, it is clear that his spirit lives on. His enduring contributions have allowed me to stand on this stage as our nation’s first African-American Attorney General, and to serve alongside our first African-American President. And the dream that he shared – on the National Mall that now includes a memorial in his honor – has inspired countless acts of compassion and collaboration, including the creation of the National Action Network more than two decades ago," said Attorney General Holder.

Yamil Navedo Ramirez, 39, was convicted of one count of attempting to possess with the intent to distribute more than five kilograms of cocaine and one count of possession of a firearm in furtherance of a drug transaction.

ING Bank N.V., a financial institution headquartered in Amsterdam, has agreed to forfeit $619 million to the Justice Department and the New York County District Attorney’s Office for conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA) and for violating New York state laws by illegally moving billions of dollars through the U.S. financial system on behalf of sanctioned Cuban and Iranian entities.

A former police officer of Puerto Rico was sentenced today in San Juan to 40 years in prison for his role in providing security for drug transactions, announced Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division and Special Agent in Charge Joseph S. Campbell of the FBI’s San Juan Division.

The Department of Justice announced today that it will require Verizon and four of the nation’s largest cable companies—Comcast, Time Warner Cable, Bright House Networks and Cox Communications—to make changes to a series of agreements concerning both the sale of bundled wireless and wireline services, and the formation of a technology research joint venture. The department said that, if left unaltered, the agreements would have harmed competition by diminishing the companies’ incentive to compete, resulting in higher prices and lower quality for consumers.

The Residential Mortgage Backed Securities Working Group members today announced their first legal action since the working group formation earlier this year.

Yamil Navedo Ramirez, 39, was sentenced today by U.S. District Judge Juan M. Perez-Gimenez in the District of Puerto Rico.

"Through the Strong Cities, Strong Communities Initiative, the White House is leading a federal effort to spark economic growth in five cities and one region, helping them to maximize resources and leverage partnerships with businesses, philanthropies, and non-profit organizations," said Acting Associate Attorney General West.

"I promised them I would never forget – just as I know you have not forgotten. On this, of all nights, let us dedicate ourselves, as Dr. King would expect us to do, to this new struggle," said Attorney General Holder.

Since that moment – thanks to the work of groups like this one, and the dedication of passionate advocates like all of you – our nation has experienced remarkable, once-unimaginable progress.

Each of these brave men and women displayed a profound love of country that must always be appreciated. It is to these people that we owe the greatest debt – Americans of all races, genders, ethnicities, sexual orientations, and backgrounds who risked everything in order that their fellow citizens, and their children, might truly be free.

A former Puerto Rico Department of Corrections officer was sentenced today to serve 811 months in prison for his role in providing armed security for three drug transactions.

The government has asked a federal court in California to issue an injunction shutting down the importation and sales activities of four California companies and six individuals in connection with their imports of illegal children’s products containing, among other things, lead, phthalates and small parts inappropriate for children under age three.

The Department of Justice has frozen more than $458 million in corruption proceeds hidden in bank accounts around the world by former Nigerian dictator Sani Abacha and conspirators.

Every April, our nation pauses to mark the contributions, and the profound sacrifices, of this extraordinary leader. Dr. King dedicated his career to the service of others.

A former private security guard was sentenced in the District of Puerto Rico today for his role in providing armed security for a drug transaction.

Officials from the Justice Department, Health and Human Services and other law enforcement partners will hold a press conference today, Tuesday, May 13, 2014, at 2:00 p.m. EDT, to announce Medicare Fraud Strike Force law enforcement actions in Miami and throughout the nation.

Attorney General Eric Holder and Secretary of Education Arne Duncan will hold a press conference to announce a major law enforcement action to protect military servicemembers from unfair lending practices today, Tuesday, May 13, 2014, at 1:15 p.m. EDT.

"By requiring Sallie Mae to compensate its victims, we are sending a clear message to all lenders and servicers who would deprive our servicemembers of the basic benefits and protections to which they are entitled: this type of conduct is more than just inappropriate; it is inexcusable. And it will not be tolerated."

Attorney General Eric Holder, Deputy Attorney General James Cole, Assistant Attorney General for the Tax Division Kathryn Keneally and IRS Commissioner John Koskinen will hold a press conference to announce a major law enforcement action.

The Justice Department today announced a multi-national effort to disrupt the Gameover Zeus Botnet – a global network of infected victim computers used by cyber criminals to steal millions of dollars from businesses and consumers – and unsealed criminal charges in Pittsburgh, Pennsylvania, and Omaha, Nebraska, against an administrator of the botnet.

Kristopher Michael Montemayor, a county commissioner for Precinct 1 of the Webb County Commissioners Court in Texas, pleaded guilty to bribery today

According to court documents submitted today, BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, agreed to enter a guilty plea to conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA) by processing billions of dollars of transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions

Today, the Department of Justice submitted to the United States District Court a criminal information against BNP Paribas, one of the largest banks in the world, for conspiring with other entities to deliberately and repeatedly violate longstanding U.S. sanctions against Sudan, Cuba, and Iran.

Today, leaders in the fight against elder abuse announced a framework for tackling the highest priority challenges to elder abuse prevention and prosecution, and called on all Americans to take a stand against the serious societal problem of elder abuse, neglect and financial exploitation

The Department of Justice has forfeited more than $480 million in corruption proceeds hidden in bank accounts around the world by former Nigerian dictator Sani Abacha and his co-conspirators

A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division

The Department of Justice, the U.S. Environmental Protection Agency (EPA) and the West Virginia Department of Environmental Protection (WVDEP) today announced a settlement with Trans Energy Inc., requiring the oil and gas company to restore portions of streams and wetlands at 15 sites in West Virginia that were polluted by the company’s unauthorized discharge of dredge or fill material. Trans Energy will pay a penalty of $3 million to be divided equally between the federal government and the WVDEP. The Clean Water Act requires a company to obtain a permit from EPA and the U.S. Army Corps of Engineers prior to discharging dredge or fill material into wetlands, rivers, streams and other waters of the United States.

Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), and Philip R

Bergstrom Nutrition, manufacturer of OptiMSM®, a branded form of methylsulfonylmethane (MSM), recently published an article detailing how the small intestine absorbs MSM, particularly in relation to sulfur.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clinical trials. More than eighty such tips appear in the July 2019 edition of Journal of Clinical Research Best Practices*.  In this post, Polaris auditors weigh in on some of their favorite MAGI suggestions. Surprising no one, they also were eager to share some of their own.

Our Favorites Tips from MAGI

So how does a clinical trial tip earn a spot on our exalted Faves List?  First, it must be something we don’t see too often, or not as much as we’d like.(If most organizations already do a useful thing, it doesn’t really qualify as a helpful tip; it’s really just a common practice.) Second, the effort to implement the tip can’t be too onerous. If a practice requires too much interdepartmental coordination, change management, training, money, or resources, it’s not a tip. It’s a full-blown initiative.

So here they are. Each tip from MAGI attendees is in bold font. Our accompanying commentary is in plain text:

• To help ensure quality study conduct, clinical sites should prepare protocol-specific quality checklists for each study. We’ve written about quality checklists from the auditing perspective before. They’re not a panacea, certainly, but that doesn’t mean they can’t be very useful.
  
  
• After study close-out, sponsors and CROs should consider holding conference calls with groups of sites to capture lessons learned. This in turn could be used to improve training, SOPs, SIVs, etc.
  
  
• As a recruitment aid, clinical sites should create pocket-sized, laminated study cards that list the inclusion/exclusion criteria for a study.  Site staff members can keep these cards in their lab coat pockets and quickly refer to them when treating a patient who could be a potential subject.
  
  
• CROs should share risk assessments and mitigation plans with Sponsors. We agree, but would also encourage CROs to keep the sites involved and aware of risks so they can anticipate them and proceed accordingly.
  
  
• Sponsors/CROs should ensure proper qualifications of vendors prior to executing contracts. It’s hard to argue with this logic, but we don’t see it as much as we should. Too often qualification audits come after the paperwork has been signed. Should the audit uncover noncompliance or quality risks at the vendor site, it’s much harder to get the vendor to make necessary changes after the contract is in place.
  
  
• CROs should align 3rd party contracts with the Sponsor/CRO contract and the Clinical Trial Agreement. Yep.

Additional Tips from Polaris QA/Compliance Auditors

The MAGI list of clinical trial tips brought others to mind that we wanted to share. We applied the same criteria to these suggestions as we did to the MAGI contributions: (1) not necessarily rare, but not as common as it could be, and (2) not overly complex or expensive to implement.

• When evaluating outsourcing partners and clinical sites, Sponsors and CROs should make sure to look at personnel turnover rates. Frequent turnovers may suggest underlying problems that could jeopardize study conduct and quality.
  
  
• Sponsors and CROs should make sure their Monitoring Report templates are consistent with the Clinical Monitoring Plan (CMP). For example:
  
  
• The CMP calls for a focus on a particular set of critical variables, but the report template only has a place for recording that 100% SDV was completed. This means that there’s no way to document that the monitor put special emphasis on anything.
• The CMP requires bi-direction review of study data – a confirmation that what is in the CRF can be verified in the source, and all pertinent data in the source can be found in the CRF – but the report template only allows for the former to be documented.
  
  
• Every member of the site team has valuable input. It’s important to include the study PI, CRC, pharmacist, and other key personnel in the discussions. In 2017, we wrote an article about the important, yet often overlooked, input that the pharmacist on site can provide.
  
  
• There are many reasons that trial participants leave a study, many of which can’t be remedied with improved site practices. But sites that demonstrate they value the participation of their study volunteers, and honor the time they’re spending and contribution they’re making, tend to have better retention results. To that end:
  
  
• To help participants schedule their time, sites can prepare calendars that include all study visit dates and indicate the activities and procedures they entail. (This, of course, needs to be approved by the IRB).
• When participants arrive, they shouldn’t have to sit in a waiting room or empty exam room; they should be seen immediately so they don’t feel their time is being wasted.
• Sites can provide beverages and light snacks to their study participants who especially appreciate them immediately after a fasting blood draw (protocol permitting, naturally). It’s a small courtesy, and not difficult to do. Whose day isn’t brightened by a proffered nosh?**

Uh oh. Now we got you all thinking about mini muffins and cheddar popcorn. Go ahead. Grab a treat. We'll talk later.

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 * Journal of Clinical Research Best Practices, July 2019

** Proffered Nosh™ would be a really great name for a restaurant. Or a fictional Scotland Yard Inspector -- legendary for his wit, brilliance, wine pairings, and fashion sense.