They've shared messages of remembrance in honour of the DJ

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"The Department of Justice and this Administration are fully committed to supporting state, local and tribal law enforcement and criminal justice agencies. The Recovery Act is not a one-time investment. Only by sustained investment in our communities can we make them safer and make them fit for long-term economic development."

The Department’s Civil Rights Division held a conference today titled 2009 Title VI Conference: Celebrating the 45th Anniversary of the Legislation and Exploring Current Issues in Enforcement at the FDIC Conference Center in Arlington, Va. Approximately 400 representatives from federal, state and local agencies, community organizations and advocacy groups gathered to share new ideas and discuss trends in Title VI enforcement.

Canadian/Lebanese dual national Ousama M. Naaman pleaded guilty today to participating in an eight-year conspiracy to defraud the United Nations Oil for Food Program (OFFP) and to bribe Iraqi government officials in connection with the sale of a chemical additive used in the refining of leaded fuel.

“Today, the department announced that it had completed negotiations to establish a $20 billion fund to provide the necessary resources to those suffering from the effects of the oil spill in the Gulf of Mexico," said Associate Attorney General Perrelli.

A former agent for Innospec Inc., a U.S. company, was sentenced today to 30 months in prison and ordered to pay a $250,000 fine for his participation in a conspiracy to defraud the United Nations Oil for Food Program (OFFP) and to bribe former Iraqi government officials in connection with the sale of a chemical additive used in the refining of leaded fuel.

Cynthia Cooley, of Hattiesburg, Miss., was sentenced by U.S. District Judge Keith Starrett in the Southern District of Mississippi.

Anthony Mangione, 52, of Parkland, Fla., was sentenced by U.S. District Judge Kenneth A. Marra in West Palm Beach, Fla.

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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Federal and local regulations are part of the solution to tough issues related to Artificial Intelligence, writes K. Gretchen Greene, but no regulatory approach on its own can fully answer these questions today. "Finding answers will require significant investments in research and development, collaboration, negotiation, and experimentation, deep and careful thought across many fields and leadership at all levels, across and between governments. The U.S. federal government is well positioned to lead, but if it won't, it should at least stay out of the way."

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Federal and local regulations are part of the solution to tough issues related to Artificial Intelligence, writes K. Gretchen Greene, but no regulatory approach on its own can fully answer these questions today. "Finding answers will require significant investments in research and development, collaboration, negotiation, and experimentation, deep and careful thought across many fields and leadership at all levels, across and between governments. The U.S. federal government is well positioned to lead, but if it won't, it should at least stay out of the way."

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Federal and local regulations are part of the solution to tough issues related to Artificial Intelligence, writes K. Gretchen Greene, but no regulatory approach on its own can fully answer these questions today. "Finding answers will require significant investments in research and development, collaboration, negotiation, and experimentation, deep and careful thought across many fields and leadership at all levels, across and between governments. The U.S. federal government is well positioned to lead, but if it won't, it should at least stay out of the way."

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Federal and local regulations are part of the solution to tough issues related to Artificial Intelligence, writes K. Gretchen Greene, but no regulatory approach on its own can fully answer these questions today. "Finding answers will require significant investments in research and development, collaboration, negotiation, and experimentation, deep and careful thought across many fields and leadership at all levels, across and between governments. The U.S. federal government is well positioned to lead, but if it won't, it should at least stay out of the way."

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