Patrick Carney of Manchester, N.H., was sentenced today in the Western District of Pennsylvania to 15 years in prison and a lifetime of supervised release for engaging in a child exploitation enterprise.

Brandon Miller, 23, of Omaha, Neb., was sentenced today to 102 months in prison and a lifetime of supervised release after pleading guilty to engaging in a child exploitation enterprise.

Abrorkhodja Askarkhodjaev was sentenced to 12 years in prison and three years of supervised release, and was ordered to pay $172,000 in restitution to the foreign worker fraud and forced labor victims in addition to restitution for harm caused by other aspects of the criminal enterprise.

Mid-America Pipeline Company LLC (MAPCO), and Enterprise Products Operating LLC, of Houston, have agreed to pay a civil penalty of more than $1 million to the United States to settle violations of the federal Clean Water Act related to three natural gasoline pipeline spills in Iowa, Kansas and Nebraska.

Van Thu Tran was sentenced today in San Diego to 36 months in prison for her role in a scheme to cheat casinos across the country out of millions of dollars.

Calling the rise in overdose deaths from heroin and other prescription pain-killers an “urgent public health crisis,” Attorney General Eric Holder vowed Monday that the Justice Department would combat the epidemic through a mix of enforcement and treatment efforts. As an added step, the Attorney General is also encouraging law enforcement agencies to train and equip their personnel with the life-saving, overdose-reversal drug known as naloxone.

The Justice Department filed a lawsuit today against Sairam Enterprises Inc. LLC alleging that it discriminated against Jeffrey Crockett and his family on the basis of disability in violation of Title III of the Americans with Disabilities Act.

A federal jury returned a verdict today convicting Shahid Hassan Muslim, aka “Sharp,” of two counts of sex trafficking, one count of kidnapping, one count of production of child pornography, one count of witness tampering and five counts of promoting a prostitution business enterprise. The verdict was announced by Acting Assistant Attorney General Molly Moran for the Civil Rights Division, U.S. Attorney Anne M. Tompkins for the Western District of North Carolina, Special Agent in Charge John A. Strong of the Federal Bureau of Investigation’s Charlotte Division and Special Agent in Charge Brock Nicholson of ICE’s Homeland Security Investigations Atlanta Division

Ministers in charge of small and medium enterprises (SMEs) in the APEC region issued a statement following their meeting in Concepcion, Chile, on 5-6 September 2019.

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.



Standard Operating Procedures (SOPs)
It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)

Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.

A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.

Training
Training can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.

The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.

It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. 

Trial Master Files (TMFs)
Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder.


Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication.

The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.

Technology to the Rescue?
No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?

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

March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […]

In the past week, Orange County has announced 21 deaths linked to COVID-19, pushing the total since the pandemic began to 71.

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Apr 4, 2020

LCPS solicited the opinion of key experts to answer one question: “Will the financial crisis, exacerbated further by COVID-19, strengthen or loosen the power of Lebanon’s governing political parties?” 

Apr 4, 2020

LCPS solicited the opinion of key experts to answer one question: “Will the financial crisis, exacerbated further by COVID-19, strengthen or loosen the power of Lebanon’s governing political parties?” 

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Apr 4, 2020

LCPS solicited the opinion of key experts to answer one question: “Will the financial crisis, exacerbated further by COVID-19, strengthen or loosen the power of Lebanon’s governing political parties?” 

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Mar 27, 2020

Nicholas Burns: Facing Two Global Crises, We Need Thoughtful Leadership In Every Country

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Sebastian Vettel admitted he was surprised to see the Ferraris catapult past him at the start of the German Grand Prix as the home favourite eventually finished back in third

Apr 4, 2020

LCPS solicited the opinion of key experts to answer one question: “Will the financial crisis, exacerbated further by COVID-19, strengthen or loosen the power of Lebanon’s governing political parties?” 

Apr 4, 2020

LCPS solicited the opinion of key experts to answer one question: “Will the financial crisis, exacerbated further by COVID-19, strengthen or loosen the power of Lebanon’s governing political parties?” 

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Mar 20, 2020

Could using the cash in your pocket have the potential to spread covid-19? That question has rarely appeared in the news, but many governments and leaders in the digital payments industry are wondering how the virus might impact the use of cash. Several countries have already taken drastic measures to limit circulation of bank notes. Could such interventions lead to the end of cash payments?

Lewis Hamilton admits he is surprised about Ferrari's competitive lap times in Friday practice but thinks he left plenty of time on the table from his own qualifying simulation

Apr 4, 2020

LCPS solicited the opinion of key experts to answer one question: “Will the financial crisis, exacerbated further by COVID-19, strengthen or loosen the power of Lebanon’s governing political parties?” 

Jan 22, 2020

The fourth consecutive month of Lebanon's unprecedented political and economic crisis kicked off this week with three dramatic developments that will interplay in the coming months to define the country's direction for years to come: Escalating protests on the streets, heightened security measures by an increasingly militarising state, and now, a new cabinet of controversial so-called "independent technocrats" led by Prime Minister-designate Hassan Diab.

Seeking to increase pressure on the political elite to act responsibly amid inaction vis-a-vis the slow collapse of the economy, the protesters had launched the fourth month of their protest movement, which had begun on 17 October last year, with a 'Week of Anger', stepping up their tactics and targeting banks and government institutions.

Being born and growing up in Ibuga refugee camp in Western Uganda, I had never felt the sweetness of my home country nor even what it looked like. As a young girl, I thought the camp was my country, only to learn that it was not. Rather, when I was 8 years old, I learned…