WILMINGTON – Gov. John Carney signed a bill Tuesday that will clarify and enforce workplace fraud rules and create a new registry to oversee contractor activity in the First State. Senate Substitute 1 for Senate Bill 95 passed the Delaware General Assembly earlier this year with nearly unanimous support and incorporates recommendations from a 2018 […]

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Facebook's new content oversight board will include a former prime minister, a Nobel Peace Prize laureate and several constitutional law experts and rights advocates in its first 20 members.

Facebook's new content oversight board will include a former prime minister, a Nobel Peace Prize laureate and several constitutional law experts and rights advocates in its first 20 members.

The company has faced criticism in recent years for its handling of issues ranging from user privacy to policing hate speech to stopping the spread of disinformation.

Facebook oversight board members will decide what Facebook and Instagram users can and cannot post on the platforms.

“Returning these funds will allow truly small businesses ... to obtain the emergency loans they need to avoid layoffs," they write.

We are a new board overseeing Facebook. Here’s what we’ll decide.Catalina Botero-Marino, Jamal Greene, Michael W. McConnell and Helle Thorning-Schmidt, The New York TimesFacebook announced the first members of its content oversight board this week, a...

"I am here today because I understand and appreciate the importance of congressional oversight, and because I am committed to ensuring the highest standards of integrity and professionalism at the Department of Justice," said Attorney General Holder.

Attorney General Eric Holder issued the following statement today.

The Justice Department is committed to vigorously investigating allegations of wrongdoing at financial institutions and, along with our many law enforcement partners, holding individuals and corporations to account for their conduct.

We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter

When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.

What does this have to do with PI oversight?



As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?

We have some suggestions.


Assessing Attention to Detail
Any GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.

This is not sexy stuff. That’s why it’s a good indicator of PI oversight.  A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.

Assessing Commitment to Protocol Compliance
During site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”

The A answer:
“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”

The F answer:
“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)

Just Ask
After reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.

There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out.

Epilogue
After running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”

My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.

I was a child bride.

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With so much money being issued so quickly, the potential for scams and misuse runs rampant.

The Swiss Federal Council will bring into force legislation on the implementation of recommendations made by the Global Forum on Transparency and Exchange of Information for Tax Purposes.

Portugal has endeavoured to maintain its foreign aid programme since the economic crisis, but its aid budget has been hit hard and a plan is needed to avoid a further decline and get back on a path towards internationally agreed targets, according to an OECD Review.

The coronavirus is proving to have an unexpected upside for the adtech industry. The U.K.’s data protection agency has paused an investigation into the industry’s processing of internet users’ personal data, saying targeted suspension of privacy oversight is merited because of disruption to businesses as a result of the COVID-19 pandemic. The investigation into adtech […]

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The youngest ever vice-chancellor of NLSIU was a Rhodes Scholar at Oxford University, and looks to establish a precedent-setting moderation model at Facebook.

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Facebook's new content oversight board will include a former prime minister, a Nobel Peace Prize laureate and several constitutional law experts and rights advocates in its first 20 members.

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The board, which will have its own website, is housed under a trust, which the social media giant says is independent of Facebook and is endowed with $130 million.