The Justice Department announced today that it will monitor primary elections on June 26, 2012, in Orange County and Queens, N.Y., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that it will monitor the elections on July 31, 2012, in Randolph and Washington Counties, Ga., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that it will monitor elections on Aug. 14, 2012, in the following jurisdictions to ensure compliance with the Voting Rights Act of 1965 and other federal voting rights statutes: Collier, Hendry, Lee, Osceola and Polk Counties, Fla.; and the city of Milwaukee, Wis.

The Justice Department announced today that it will monitor elections on Aug. 28, 2012, in Lanett, Reform, and Phenix City, Ala., and Maricopa County, Ariz., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that it will monitor elections on Sept. 13, 2012, in the Bronx, Manhattan and Queens, N.Y., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that it will monitor portions of the early voting period for the Nov. 6, 2012, general election in Dallas and Harris Counties, Texas, to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group. Early voting in Dallas and Harris Counties begins on Monday, October 22.

The Justice Department announced today that it will monitor portions of the early voting period for the Nov. 6, 2012, general election in Miami-Dade County, Fla., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that its Civil Rights Division plans to deploy more than 780 federal observers and department personnel to 51 jurisdictions in 23 states for the Nov. 6, 2012, general election.

The Justice Department announced today that it will monitor the municipal special election on Jan. 8, 2013, in Branchville, S.C., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that the Civil Rights Division will monitor elections on Feb. 26, 2013, in Cook County, Ill., and Seward County, Kan.

The Justice Department announced today that it will monitor the municipal election on March 12, 2013, in the town of Guadalupe, in Maricopa County, Ariz., to ensure compliance with the Voting Rights Act of 1965.

The United States and the city of New Orleans announced today that public meetings would be held regarding a consent decree court monitor for the New Orleans Police Department.

The Justice Department announced today that it will monitor elections on March 19, 2013, in Beaufort, Berkeley, Charleston and Dorchester Counties, S.C., and in the village of Port Chester, N.Y.

The Justice Department announced today that the Civil Rights Division will monitor elections on April 2, 2013, in Finney County, Kan., and Douglas County, Neb. The monitoring will ensure compliance with the Voting Rights Act of 1965 and other federal voting rights statutes.

The U.S. Department of Justice and the U.S. Environmental Protection Agency (EPA) announced a Clean Air Act (CAA) settlement with Tyson Foods Inc. and several of its affiliate corporations to address threats of accidental chemical releases after anhydrous ammonia was released during incidents at facilities in Kansas, Missouri, Iowa and Nebraska, resulting in multiple injuries, property damage and one fatality.

The Justice Department announced today that it will monitor elections on May 7, 2013, in the towns of Clarksdale, Como and Ruleville, Miss., and in Charleston County, S.C., to ensure compliance with the Voting Rights Act of 1965.

The Justice Department announced today that it will monitor municipal elections on May 11, 2013, in the cities of Corrigan, Farmers Branch, Irving and Orange, Texas, to ensure compliance with the Voting Rights Act of 1965.

The Justice Department announced today that the Civil Rights Division will monitor the election on May 14, 2013, in Douglas County, Neb.

The Justice Department announced today that it will monitor municipal elections on June 4, 2013, in the cities of Brookhaven, Greenwood, Isola, Meridian, Philadelphia and Ruleville, Miss., to ensure compliance with the Voting Rights Act of 1965.

The Justice Department announced today that it will monitor the municipal election on June 18, 2013, in the city of Evergreen, Ala., to ensure compliance with the Voting Rights Act of 1965.

The Justice Department announced today that it will monitor elections on Sept. 10, 2013, in Cuyahoga County, Ohio, and in Queens County, N.Y. The monitoring will ensure compliance with the Voting Rights Act, which prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

The Justice Department announced today that it will monitor the special municipal election on Sept. 24, 2013, in Hattiesburg, Miss.

The Justice Department announced today that it will monitor elections on Nov. 5, 2013, in Detroit and Hamtramck, Mich.; Orange County, N.Y.; and Cuyahoga and Lorain Counties, Ohio.

The Justice Department announced today that it will monitor elections on May 13, 2014, in Colfax and Douglas Counties, Nebraska, to ensure compliance with the Voting Rights Act and other federal voting rights statutes.

The Justice Department announced today that it will monitor elections on June 3, 2014, in Alameda and Napa Counties, California, and Cibola County, N.M., to ensure compliance with the Voting Rights Act and other federal voting rights statutes.

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

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.

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

The company is further looking to raise Rs 250 crore in the next few quarters. 

The post India Deal Monitor: MYSUN snags about $4.3m funding and more updates appeared first on DealStreetAsia.

The funding will be used to spruce up technology and expand product offerings.

The post India Deal Monitor: RTP Global leads $9m funding in Classplus and more updates appeared first on DealStreetAsia.

Exfinity Ventures and IAN Fund led the funding in Vernacular.ai.

The post India Deal Monitor: Vernacular.ai raises $5.1m in Series A round and more updates appeared first on DealStreetAsia.

Iran is posing a comprehensive challenge to the interests of the United States and its allies and partners in the Middle East. Over the past four decades, it has managed to establish an “arc of influence” that stretches from Lebanon and Syria in the Levant, to Iraq and Bahrain on the Gulf, to Yemen on […]

Iran is posing a comprehensive challenge to the interests of the United States and its allies and partners in the Middle East. Over the past four decades, it has managed to establish an “arc of influence” that stretches from Lebanon and Syria in the Levant, to Iraq and Bahrain on the Gulf, to Yemen on […]

It would be hell if the Covid-19 breaks out in Nigeria on the scale presently being witnessed in Europe and the US. Apart from the dire state of the healthcare system, 69 million Nigerians have no access to clean water. This invariably leads to water-borne diseases like cholera, which continue to break out as regular epidemics. Social distancing and self-isolation presuppose that people have enough space. In Lagos where we have over 100 slum areas, about 80 people can be found sharing a 10-room building with only two toilets and a bathroom being shared by all with no pipe-borne or treated water readily available.

I knew that real-time data on our energy use would be interesting. But I wasn't sure how much it would actually save us.

While the NYT article offers an exaggerated cautionary tale, its alarm-ism can lead many to throw the beautiful practice of yoga asanas (postures) out with the bathwater.

The successful launch of Sentinel-5P means scientists will soon have access to the most accurate monitoring yet of pollution and climate change related gases in earth's atmosphere

Pollution from power plants, cars, and other transportation is a well-known contributor to outdoor air pollution, but our indoor air quality is often worse; it can be up to 10 times worse for you than the air outside. Microbial pollutants like mold,

Bourgeois / Lechasseur architects figure out how to square the circle.

The tech helps owners take care of their dogs the way the dogs take care of them.

Scientists will be able to easier monitor the population of penguins, thanks to a high-tech solar-powered remote camera setup.

The laser-outfitted satellite will be able to pick up shifts in the ice on a very small scale.

Provincial regulation would make stores' waste-reduction efforts easier to manage.