The Justice Department today announced agreements with the cities of Fort Myers, Fla., and Newport, R.I., to improve access to all aspects of civic life for individuals with disabilities.

The Justice Department today announced an agreement with Fairfax County, Va., to improve access to all aspects of civic life for persons with disabilities.

An agreement has been reached with the town of Swansea, Mass., to improve access to all aspects of civic life for persons with disabilities.

An agreement has been reached with the city of Des Moines, Iowa, and the Des Moines Public Library, to improve access to all aspects of civic life for persons with disabilities.

The Justice Department today announced an agreement with the city of Independence, Kan., to improve access to all aspects of civic life for people with disabilities.

The Justice Department today announced an agreement with Van Buren County, Ark., to improve access to all aspects of civic life for persons with disabilities. The agreement was reached under Project Civic Access, the department’s wide-ranging initiative to ensure that cities, towns and counties throughout the country comply with the Americans with Disabilities Act.

The Justice Department today announced agreements with Norfolk County, Mass.; Daviess County, Ky.; and the city of Madison, Indiana, to improve access to all aspects of civic life for individuals with disabilities.

The Justice Department today announced an agreement with Montgomery County, Md., and Maryland National Capital Park and Planning Commission (MNCPPC), to improve access to all aspects of civic life for persons with disabilities.

The Justice Department today announced an agreement with the town of Warrenton, Va., to improve access to all aspects of civic life for individuals with disabilities. The agreement was reached under Project Civic Access.

The Justice Department today announced an agreement with Upshur County, Texas, to improve access to all aspects of civic life for people with disabilities.

The Justice Department today announced an agreement with the city of Humboldt, Kan., to improve access to all aspects of civic life for individuals with disabilities.

The Justice Department today announced agreements with Wills Point, Texas, and Randolph County, Ga., to improve access to all aspects of civic life for individuals with disabilities

The agreement is the 200th settlement reached under Project Civic Access (PCA), the department’s wide-ranging initiative to ensure that cities, towns and counties throughout the country comply with the Americans with Disabilities Act (ADA).

The Justice Department today announced an agreement with Schuylkill County, Pa., to improve access to all aspects of civic life for persons with disabilities. The agreement was reached under Project Civic Access (PCA), the department’s initiative to ensure that cities, towns and counties throughout the country comply with the Americans with Disabilities Act (ADA).

The Justice Department has reached an agreement with the city of Memphis, Tenn., under the Americans with Disabilities Act (ADA) to improve physical accessibility for people with disabilities at Liberty Bowl Memorial Stadium, home of the AutoZone Liberty Bowl, Memphis Tigers and Southern Heritage Classic football games.

The Justice Department today announced an agreement with Stewart County, Ga., to improve access to all aspects of civic life for persons with disabilities.

The Justice Department today announced an agreement with the City of West Columbia, S.C., to improve access to all aspects of civic life for persons with disabilities.

The Justice Department announced today an agreement with the town of Poestenkill, N.Y., to improve access to all aspects of civic life for persons with disabilities.

The Justice Department announced today an agreement with the city of Fort Morgan, Colo., to improve access to all aspects of civic life for persons with disabilities.

Under an agreement announced today by the U.S Environmental Protection Agency and the U.S. Department of Justice, the Virgin Islands Water and Power Authority (VIWAPA) will come into compliance with air pollution control requirements in the federal Clean Air Act at its Estate Richmond Generating Facility located on St. Croix, U.S. Virgin Islands.

Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

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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