Especially as we approach the 60th anniversary of the Supreme Court’s decision in Brown v. Board of Education, in which Chief Justice Earl Warren called education “a right which must be made available to all on equal terms,” it is imperative that we do everything in our power to end policies or practices that deny this right to those who are constitutionally entitled to it.

Within the Department, we have moved forward with our groundbreaking Diversity Management Initiative to promote diversity within our own ranks. Through our close partnership with the Federal Asian Pacific American Council, we have helped to create considerable new opportunities for our employees to thrive – both personally and professionally. And thanks to the tireless efforts of employee organizations like DOJ Pan Asia and others, we continue to encourage every member of the DOJ family to grow, to learn, and to advance in their lives and careers.

As difficult as times may be – and as wrenching as every loss we mark this evening – we affirm this week that our work must go on. Each of us is called to serve, to protect, and to help forge a society worthy of the passion, the dedication, and the sacrifices made by each of our fallen heroes. To create not merely a monument to their stories, but a living memorial. And to build a country dedicated to preserving and perpetuating their memories by reaching for the better and brighter future that all of our citizens deserve.

The Justice Department’s Civil Division announced today that Electrolux Home Products Inc., of Charlotte, North Carolina, has agreed to pay a civil penalty of $750,000 to settle allegations that it knowingly failed to report immediately to the U.S. Consumer Product Safety Commission a safety hazard associated with certain wall ovens sold to consumers.

Since 1940, LDF has performed critical work to rally Americans from all backgrounds to the unifying cause of justice – standing on the front lines of our fight to guarantee security, advance opportunity, and ensure equal treatment under law.

Progress can be achingly slow – but in this country, as a courtroom full of men and women was reminded six decades ago, our destiny is of our own design.

Today, we pay tribute to this remarkable leader. We thank her for bearing these burdens, and leading these efforts, with grace and with poise.

The work of these honorees in rescuing missing and exploited children – and in bringing perpetrators of these heinous crimes to justice – is exceptional. It takes very special people to perform such difficult – and in many cases heart-wrenching and life-changing – duties.

Eric Esposito was sentenced today to serve 27 months in prison for conducting an illegal gambling business on behalf of the Philadelphia La Cosa Nostra Family.

Evgeniy Bogachev and the members of his criminal network devised and implemented the kind of cyber crimes that you might not believe if you saw them in a science fiction movie. By secretly implanting viruses on computers around the world, they built a network of infected machines – or “bots” – that they could infiltrate, spy on, and even control, from anywhere they wished.

Today, we are here to announce that, over the weekend, the Department disrupted two extremely damaging cyber threats – the financial botnet known as Gameover Zeus and the malicious software known as Cryptolocker.

When I think about what it means to be an engaged citizen and a role model, I think of – and am thankful for – my own wonderful father, whom I loved, admired and miss every day.

Today, we have the privilege of hearing from two of the tenacious legal advocates who made last year’s landmark Supreme Court decision possible. First, it’s my pleasure to hand things over to our keynote speaker, Roberta Kaplan – who argued the Defense of Marriage Act challenge on behalf of Edith Windsor.

And it’s not enough until the circle of opportunity and equality is so wide – and so accessible – that the American Dream is available to everyone with the heart to dream it.

As the Attorney General recently observed, heroin and opiate addiction and abuse “is impacting the lives of Americans in every state, in every region, and from every background and walk of life.”

Ultimately, as your history reminds us, these efforts will be successful only if we take responsibility not just for ourselves, but for our families, our neighbors, our friends, and our fellow citizens. Among them are the future “heroes for hope” that this city, this state, and this country desperately need.

Attorney General Eric Holder released the following statement Tuesday regarding the arrest of Ahmed Abu Khatallah for his role in the attack on the U.S. facilities in Benghazi, Libya

You know as well as anyone that the challenges we face are daunting. You’ve shown us that, as we seek to address the problem of substance abuse, it makes sense to focus on the most dangerous types of drugs. And right now, few substances are more lethal than prescription opioids and heroin.

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.

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.

George Washington himself conceived and designed them, but it was Mount Vernon’s other residents -- the hundreds of men and women who worked for Washington -- it was their hands that built and tended this splendor. Like you, those men and women had origins that stretched around the globe. They were Christians and Muslims; Africans and Europeans.

Attorney General Eric Holder will deliver the keynote address at the Department of Justice’s 50th anniversary celebration of the Civil Rights Act of 1964. Secretary of Labor Thomas Perez, Secretary of Education Arne Duncan, Congresswoman Eleanor Holmes Norton, Deputy Attorney General James Cole, Associate Attorney General Tony West, Ambassador Andrew Young and Howard University Interim President Dr. Wayne A.I. Frederick will also deliver remarks at the event co-hosted by Howard University, on TUESDAY, JULY 15, 2014, at 10:00 a.m. EDT, to honor the civil rights movement and celebrate the groundbreaking act

"We must recommit ourselves to the legacies of visionary leaders and courageous citizens who made the passage of the Civil Rights Act, and the creation of this agency, possible. And we must resolve to keep moving forward together – as one nation and one people – driven by the needs that remain unfulfilled, determined to transcend the barriers that still divide us, and dedicated to the enduring promise of equal justice under law."

That, at its core, is what defines us as Americans: a people born of revolution and tested by civil war. A nation founded on equality but built by those in chains. A country first imagined, centuries ago, by imperfect people driven by a near-perfect vision – a vision conceived by patriots who dared to reach beyond themselves and defended later by activists who fought for equal justice – and who challenge us, even today, to make this promise real.

Today, we are privileged to be joined by two national leaders who have worked tirelessly to "pay it forward" by devoting their lives to promoting justice, fairness, and equality.

History is not just a series of events; it is the people who create those events. It is the impact of the stories—told and untold—of the many trailblazers and unsung heroes whose tireless sacrifices and relentless dedication have resulted in justice, equality, opportunity, and freedom for all.

I am honored to join you in this pursuit. I congratulate you, once again, on this extraordinary occasion. And I thank you for allowing me to share it with you.

As the Secretary has so poignantly described, the conditions for these migrants en route to the United States are horrible. Human smuggling ventures lead to extremely dangerous circumstances that pose a threat to public safety and are serious humanitarian concerns. We have encountered smuggled aliens that have been, kidnapped, taken hostage, beaten, sexually assaulted, threatened with murder or have died as a result of dangerous conditions.

The Department of Justice’s Office of Justice Programs (OJP), in partnership with the International Association of Chiefs of Police (IACP), today released a seminal model policy regarding police interaction with children who are impacted when a parent is arrested and law enforcement carries out its investigative and arrest responsibilities. Reflecting the collective input of a wide range of subject-matter experts and stakeholders, and understanding that interactions between children and law enforcement create lasting impressions, the resulting model policy, Safeguarding Children of Arrested Parents , provides strategies for law enforcement to improve their procedures and positively impact the communities they serve

"Because if a government of, by and for the people means anything at all, it means that a ballot has the power to give equal voice to the high and the low; the weak and the strong; those at the bottom as well as the top. It means that in the polling place, the line is just as long for the richest among us as it is for those who often work the hardest but have the least."

Mr. Chairperson, distinguished Members of the committee, and representatives of civil society. My name is Mark Kappelhoff and I serve as a Deputy Assistant Attorney General in the Civil Rights Division of the U.S. Department of Justice. It is an honor to be a member of the U.S. delegation and to share with you some of the Justice Department’s work to address racial discrimination and to fulfill our obligations under the convention.

Mr. Chairperson, distinguished members of the committee, and representatives of civil society, it is an honor to be a part of the U.S. delegation and share some of the highlights of the Department of Justice’s efforts to eliminate racial discrimination and uphold human rights in the area of criminal justice.

We have brought to this area very experienced prosecutors, we have very experienced agents who are handling this matter, and doing so, I think, in a fine way. I'm going to get briefed on more of the details about the investigation. I've been kept up to date, but there's nothing that can replace actually coming to the office that's handling the matter, and being able to look in the face the people who are, I think at this point, very ably handling this investigation.

"We are here to announce a historic step forward in our ongoing effort to protect the American people from financial fraud – and to hold accountable those whose actions threatened the integrity of our financial markets and undermined the stability of our economy."

"Yet in addition to accountability, this historic resolution is also significant for what it achieves in terms of restoration: it requires those we are holding accountable to shoulder some of the responsibility for repairing the damage caused by their conduct."

Political consultant Gregory Naylor, 66, of Philadelphia, pleaded guilty today to making false statements to federal agents and misprision of a felony in connection with his role in attempting to conceal two campaign finance-related fraud schemes

"These anecdotal accounts underscored the history of mistrust of law enforcement in Ferguson that has received a good deal of attention. As a result of this history – and following an extensive review of documented allegations and other available data – we have determined that there is cause for the Justice Department to open an investigation to determine whether Ferguson Police officials have engaged in a pattern or practice of violations of the U.S. Constitution or federal law."

Attorney General Eric Holder released the following statement Friday announcing that Stuart Delery, who currently serves as Assistant Attorney General for the Civil Division, will serve as Acting Associate Attorney General, which is the Justice Department’s third-ranking post.

The Department of Justice announced today that it has entered into a settlement agreement with the School District of Philadelphia that resolves a religious accommodations lawsuit filed in March 2014. In its lawsuit, the United States alleged that the school district violated Title VII of the Civil Rights Act of 1964 (Title VII) by failing to accommodate the religious beliefs, observances and/or practices of Siddiq Abu-Bakr, a school police officer who is Muslim, and similarly-situated employees who maintain a beard longer than one-quarter inch for religious purposes.

"At every level, Tony West has come to exemplify what it means to be a public servant in the truest sense. To many who are at risk and in need, he has become known as a champion. To those who have broken the law and victimized others, he has been a fierce and determined guardian of the public trust. And to me, he has been a trusted advisor, a dedicated colleague, and a dear friend."

"I love this department because of its unique mission. It's an audacious one -- I suppose with a name like “Justice” audacity is appropriate. It's a mission that speaks to the fundamental importance of the Rule of Law, as represented by that statue on your far right, aptly named the “Majesty of Law,” a bundle of arrows in hand."

Thank you, John, not only for that kind introduction but also for your exemplary leadership as chair of the LSC Board. LSC really exemplifies that spirit Attorney General Robert Kennedy used to talk about – that as lawyers, we have an obligation to enlist our skills and ourselves in engagements that reach beyond the horizons of our parochial legal practices. And over the last five-and-a-half years I’ve served in this Administration, I’ve been fortunate to get to know John and LSC President Jim Sandman, and I know the movement for expanding access to justice in this country is better and stronger because they’re helping to lead this effort, so my thanks to them.

Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

Remarks as prepared for delivery

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

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.

Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial.

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

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

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.

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

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…