Anthony K. Mastrogiovanni, 30, of Crofton, Md., was sentenced today to serve 25 years in prison for sexually exploiting more than 30 male juveniles – ranging from 9 to 16 years of age – in Maryland and Louisiana to produce child pornography.

The Attorney General issued the following statement today in the wake of the tragedy at the Washington Navy Yard.

The Civil Rights Division and U.S. Attorney Carmen M. Ortiz announced today the filing of a complaint alleging that the International Association of Bridge, Structural, Ornamental and Reinforcing Iron Workers Local 7 (the union) and Iron Workers District Council of New England Pension Fund (the Pension Fund) willfully violated the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA) by failing to credit U.S. Navy Reserve Member Thomas Shea with service time while he was serving in the armed forces in Afghanistan.

Assistant Attorney General for the Tax Division Kathryn Keneally and U.S. Attorney Melinda Haag for the Northern District of California announced that Noemi Rubio Baez, of Salinas, Calif., pleaded guilty to conspiracy to file false claims for tax refunds with the Internal Revenue Service (IRS) and to aggravated identity theft.

A third senior U.S. Navy official has been charged in a complaint unsealed today with accepting prostitutes, luxury travel and $100,000 cash from a foreign defense contractor in exchange for classified and internal U.S. Navy information, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and U.S. Attorney Laura E. Duffy of the Southern District of California.

Tommy Edward Clack pleaded guilty in federal court in Greensboro, N.C., to one count of willfully filing a false federal income tax return and one count of knowingly making a false statement to a federally-insured bank in order to obtain a mortgage loan, the Justice Department and the Internal Revenue Service (IRS) announced today.

Attorney General Eric Holder today announced Ronald L. Davis as the director of the Office of Community Oriented Policing Services.

Former Jefferson Parish Sheriff’s Deputy Mark Hebert, 48, pled guilty today to one civil rights violation, five bank fraud violations and one aggravated identity theft violation, announced Acting Assistant Attorney General Jocelyn Samuels for the Civil Rights Division, U.S. Attorney Kenneth A. Polite Jr. for the Eastern District of Louisiana, Special Agent in Charge Michael J. Anderson of the FBI New Orleans Field Office and Sheriff Newell Normand from the Jefferson Parish Sheriff’s Office.

A special agent with the Naval Criminal Investigative Service (NCIS) pleaded guilty today to participating in a massive international fraud and bribery scheme

The Justice Department announced today that Fort Davis State Bank, based in Fort Davis, Texas, will implement uniform pricing policies, conduct employee training and pay $159,000 as part of a settlement to resolve allegations that it engaged in a pattern or practice of discrimination on the basis of national origin.

A 63-count superseding indictment charging Chatonda Khofi, Ishmael Kosh, Amadou Sangaray and Francis Saygbay in a conspiracy to defraud the Internal Revenue Service (IRS) was unsealed on Monday, December 23, in Minneapolis, Minn.

Today the District Court in the District of Columbia dismissed a challenge filed by the Florida Bankers Association and Texas Bankers Association challenging 2012 amendments to the Department of the Treasury’s interest-reporting regulations.

Vector Planning and Services Inc. (VPSI), an information technology, systems engineering, program management and consulting firm headquartered in Chantilly, Va., has agreed to pay the government $6.5 million to settle False Claims Act allegations that the company inflated claims for payment under several Navy contracts.

A civilian employee of the U.S. Navy posted at the Capodichino Navy Base near Naples, Italy, was arraigned yesterday in Norfolk, Va., for allegedly obtaining more than $360,000 in housing benefits that he was not entitled to receive.

Richard Castle, 47, a resident of the United Kingdom, has been sentenced to serve 192 months in prison in connection with a trip he made to Ohio from his home in the United Kingdom to have illicit sexual activity with a minor in June 2011.

Alex Wisidagama, a citizen of Singapore formerly employed by Glenn Defense Marine Asia (GDMA), pleaded guilty today to one count of conspiracy to defraud the United States for his role in a scheme to overbill the U.S. Navy for ship husbanding services.

A Southern California man who ran a durable medical equipment (DME) supply company has been found guilty by a federal jury in Los Angeles for his role in a $1.5 million Medicare fraud scheme.

Tommy Edward Clack was sentenced today to serve 66 months in federal prison for tax and fraud crimes by U.S. District Judge Thomas D. Schroeder in Winston-Salem, N.C., the Justice Department and Internal Revenue Service announced.

A fourth U.S. Navy official has been charged in a complaint unsealed today with accepting cash, luxury travel and consumer electronics from a foreign defense contractor in exchange for classified and internal U.S. Navy information.

In an important step to reduce sentencing disparities for drug offenders in the federal prison system, Attorney General Eric Holder on Monday announced that the Justice Department will soon detail new, more expansive criteria that the Department will use in considering when to recommend clemency applications for the President’s review.

The Department of Justice today announced that Joseph F. Klimavicz will become its new chief information officer (CIO), arriving in late May.

In today’s nationwide takedown, scores of defendants were arrested across the country for engaging in health care fraud – to the tune of hundreds of millions of dollars in fraudulent bills to Medicare. Among the defendants charged today were doctors, home health care providers, doctor’s assistants, pharmacy owners and medical supply company executives.

U.S. Navy Petty Officer First Class Daniel Layug pleaded guilty in the Southern District of California today to accepting more than $10,000 in cash, consumer electronics and travel expenses from a foreign defense contractor in exchange for classified and internal Navy information.

Scott B. Miserendino, Sr., 55, a former government contractor who performed work for the United States Navy Military Sealift Command, and Timothy S. Miller, 57, a businessman whose company sought contracting business from the Military Sealift Command, were indicted today on charges including conspiracy and bribery.

Deputy Attorney General James M. Cole and Principal Deputy Assistant Attorney General for Justice Programs Mary Lou Leary announced today that the vast majority of U.S. states and territories have informed the Department of Justice that they intend to take steps to reduce sexual assaults in prisons, in accordance with federal law.

A retired Navy official who started a second career working for defense contractor Glenn Defense Marine Asia (GDMA) pleaded guilty in federal court today, admitting that he and others overcharged the Navy by up to $2.5 million for port services to American ships and then used some of the proceeds to treat Navy officials to lavish dinners, cocktails and entertainment

Kenny E. Toy, 54, the former Afloat Programs Manager at the United States Navy Military Sealift Command, was sentenced today to serve 96 months in prison for receiving bribes

Gregory King, 28, of Washington, D.C., pleaded guilty today in connection with contacting a 13-year-old girl over the Internet and traveling across state lines to engage in sexual activity with her

A former employee of a government contracting company was sentenced today to 36 months in prison to be followed by three years of supervised release for conspiracy to bribe public officials at the United States Navy Military Sealift Command in exchange for favorable treatment in connection with U.S. government contract work

The Justice Department reached an agreement today with Travel Management Company, a private airplane charter company based in Elkhart, Indiana, resolving claims that the company engaged in citizenship status discrimination in violation of the Immigration and Nationality Act (INA).

The remaining two defendants of 36 accused in the Southern District of Texas of racketeering activities as part of their roles with the Aryan Brotherhood of Texas (ABT) have pleaded guilty, capping a six-year sweeping effort that has led to 73 convictions across five federal districts and the decimation of the gang’s leadership and violent members and associates. Those convicted were charged with involvement in a criminal organization that engaged in murders, kidnappings, brutal beatings, fire bombings and drug trafficking

A 65-year-old registered sex offender, with two prior convictions relating to possession of child pornography and attempted sexual conduct with minors, was found guilty today of attempting to produce child pornography, travel with intent to engage in illicit sexual conduct, transporting child pornography, possessing child pornography and offense by a registered sex offender

An owner of an electrical contracting company pleaded guilty today to falsifying disclosure documents required under the Employee Retirement Income Security Act (ERISA), by intentionally under-reporting hours worked by employees to avoid contractually required contributions to employee benefit plans.

NORFOLK, Va

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.

Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses.

Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name.

The following are some of the stocks in the healthcare sector that touched a high yesterday. Will the rally continue?

Communities and policymakers working to meet the challenges of a global pandemic may need to take a range of targeted actions, such as building awareness, launching preventive measures, boosting health care infrastructure, or allocating emergency funding. These decisions, which can influence health outcomes significantly, highlight the importance of having the information needed to evaluate...

Testing for the novel coronavirus in the United States has not kept pace with the enormous demand despite national efforts to ramp up capacity.

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

Older adults who consumed large amounts of flavonoid-rich foods were two to four times less likely to develop Alzheimer's disease and related dementias over 20 years compared with people whose intake was low, in a study of 2,800 people.

An APEC Business Travel Card mobile application will make travel easier and more secure

Medical supplies and personal protective products are facing barriers worldwide

Year in and year out, protocol deviations are the most common FDA Site Inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this finding also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.

Why does this keep happening?



The Nature of Protocols
This will come as a surprise to no one: not all protocols are well written.  Important procedures can be hidden in the most obscure places.  Charts depicting Time and Events Schedules are famous for carrying dozens of footnotes that appear nowhere else in the protocol, yet convey important study procedures.   For instance, a pre-dosing column may include a footnote that provides a timeframe for performing a physical exam; a post-dosing footnote might specify the interval at which vitals must be taken.   Failing to follow study procedures compromises subject safety and data integrity; FDA won’t care whether the procedures were in big bold italics or 7-point font.

This, too, may come as no surprise, but not all protocols are error-free.   Information in charts may not match the narrative.  Procedures in Section A may conflict with procedures in Section B.  When the FDA investigator spots an inconsistency, you’ll be asked which of the two conflicting procedures you followed and why.  If you performed procedure A only because you didn’t even notice there was a B, it will be clear you didn’t read the protocol as thoroughly as you needed to.  The FDA investigator may become concerned that your study execution differed from the sponsor’s intention.  This is not a concern you want to trigger.

For these reasons, it’s imperative that study staff read and understand the protocol.  Study team members need to ask questions about anything they’re unsure of, seek clarification on protocol inconsistencies, and get responses that satisfy before starting the study.   A PowerPoint overview is not sufficient training.

One more irksome attribute of protocols that can make them difficult to follow -- they change.  While most study sites allocate time and resources for initial protocol training, many lack a plan for training staff on protocol amendments.   A disproportionate number of protocol deviations occur in amended procedures, and it’s often because staff members have been insufficiently trained on them.  (And when you do train on protocol amendments, don’t forget to document it.)

Deviation Temptation
A protocol is not a suggestion; PIs cannot substitute their own judgment for prescribed procedures, no matter how well-intentioned the departure.  The protocol for a psoriasis study might call for the PI to perform a series of punch biopsies, very invasive procedures.  After the first biopsy, an empathetic PI might be tempted to skip a second if he observes the plaque is clearing up; the drug is working.  But this would be a protocol deviation.  The protocol for another study might preclude the use of a particular drug, even though the drug is routinely used throughout the practice to treat a symptom that a study participant is exhibiting.  But the study protocol trumps standard of care; prescribing the drug would be a protocol deviation.

A PI who feels she must deviate from the protocol for some reason must obtain prior approval, since failure to follow the protocol can jeopardize the reliability of the study data, if not subject rights and safety.



Deviations Happen
So you’ve thoroughly read the protocol, you’ve asked your questions and received the necessary clarifications, you’ve trained your staff on the protocol and its amendments, and you do your best to follow them.

Despite all your preparation and vigilance, protocol deviations happen.  They just do.  And when they do, here are two don'ts.

(1) Don’t panic.

(2) Don’t let an FDA investigator find them first.
Take the time to fully document any protocol deviations.  Be sure to record why they happened, how they were corrected, and what was submitted to the IRB.

[Note: IRBs have different requirements about what types of protocol deviations should be communicated.  Out-of-window visits are common and are frequently considered too minor to report.  But nothing’s black and white.  If the missed visit resulted in missed doses, that would probably change the calculus. The PI needs to determine whether to notify the IRB, and if no submission is thought necessary, it’s a good idea to document why not.]

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

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