text:
E-Verify Battle Could Soon Greet Texas Lawmakers
At least half a dozen bills have been filed in the Texas House mandating the use of the federal electronic employment verification system known as E-Verify. But is the system so fraught with errors that it actually hinders employers who use it to check the eligibility of new hires?
by Julián Aguilar Feb. 3, 2011 5 AM Central
Credit: Illustration by Todd Wiseman
State legislators intent on cracking down on the hiring of undocumented workers could be embracing a system so fraught with errors that some critics say it actually hinders employers who use it to check the eligibility of new hires. Employers could also be caught up in a constitutional legal battle in the process.
At least half a dozen bills have been filed in the Texas House mandating the use of the federal electronic employment verification system known as E-Verify. U.S. Citizen and Immigrant Services manages the system, which compares the information potential workers submit to an employer on their I-9 — a federal document that collects employment-eligibility information — to records maintained by the Department of Homeland Security and the Social Security Administration.
The system is required only for employers with federal contracts, but the federal government says volunteer participation is growing at the rate of approximately 1,000 new businesses signing up every week, adding to the 225,000 already using it.
The legislation filed so far would mandate wider use of the system in Texas, mainly for businesses that receive state and federal grants or subsidies. House Bill 582, authored by by state Rep. Angie Chen Button, R-Richardson, would require businesses that receive certain public subsidies to use the system. HB 140 by state Rep. Jodie Laubenberg, R-Parker, and HB 202 by Rep. Burt Solomons, R-Carrollton, would require state contractors to enroll. HB 178, by Jim Jackson, R-Carrollton, would require state government agencies and departments to use the system, while HB 601, also by Jackson, would require use of E-Verify by any "governmental entity" including any political subdivision of the state, like a county or city government or school district.
Some business leaders argue that mandating wider use is inherently unconstitutional because immigration law is the jurisdiction of the federal government alone — a matter now before the U.S. Supreme Court — while others point to serious flaws in the E-Verify system.
"A difficult process"
Before she was a lawmaker, state Rep. Patricia Harless, R-Spring, was in the automotive business, which she said is often viewed as lax in its hiring practices. She volunteered her business, which sells and repairs cars, to participate in E-Verify as a defense.
"I wanted to see how it worked. I am in the car business, and a lot of times we are targeted as saying we hire illegals, so I wanted to have the documentation," she said. "Of course, being in the political environment, I just wanted to be above-board."
How she and her colleagues who are also business owners or employers decide how to vote on the issue will be heavily influenced by their experiences, not necessarily their party loyalty. Harless said she is tentatively supportive of the intent of the legislation. But she has encountered several problems with E-Verify — even with details as seemingly minor as a hyphenated name — that have led her to question its usefulness.
"I just have to see what the mandates are," she said. "It is really difficult for an employer, and it is really difficult to get the [hiring] process checked."
She has seen applicants she thought were legitimate get flagged and others she's had doubts about pass through. Getting a problem corrected could take days, she said.
Her complaints are backed up the government, which has acknowledged for years the system is flawed. A report last month by the Government Accountability Office, the investigative arm of Congress, found that although E-Verify has improved, it still contains numerous flaws.
"If an authorized employee's name is recorded differently on various authorizing documents, the E-Verify system is to issue a TNC [temporary non-confirmation] for the employee," states a report summary. "Because such TNCs are more likely to affect foreign-born employees, they can lead to the appearance of discrimination." The accountability office touts gains made to improve the system, including the increase in the number of databases queried through E-Verify. That helped lead to the authorization of more than 8 million newly hired employees last year. But the system is still susceptible to identity theft and employer fraud.
Freshman state Rep. Paul Workman, R-Austin, also knows the challenges — and the suspicions — associated with his industry, the construction business.
"The concept of E-Verify is fine. The practice of E-Verify, however, is not so fine. There are a number of issues," he said. "Are there illegals out there working in the construction industry? Yes, probably so. But I believe, at least in the commercial market, that most people are following the law as it relates to their hiring practices. But we'll just have to wait and see what these bills look like and see how they impact our economy."
Jackson, one of the legislators promoting increased use of E-Verify, acknowledged the concerns and said there can be room for improvement. In fact, he said, he is crafting legislation that would only require that a company or a government use E-Verify or forgo any state revenue or state government contracts. But bills can be tweaked, he said, to make sure employers aren't held accountable for a faulty system.
"We intend to hold harmless those people that use it. You are not liable if you use it. You are only liable if you don't use it," he said. "That is what our intent is going to be, and if it's not made clear, we will try to make it clear in committee with amendments."
The U.S. Supreme Court
Even if Texas moves forward with any form of mandatory use of E-Verify, the legislation could still face legal challenges. A case currently before the U.S. Supreme Court, Chamber of Commerce of the United States v. Whiting, could determine whether states are allowed to mandate use of the system. The Legal Arizona Workers Act, passed in 2007 and signed into law by then-Arizona Gov. and current Secretary of Homeland Security Janet Napolitano, is far more expansive than the proposed Texas legislation. It requires that all employers in Arizona use E-Verify. Those who do not comply risk losing their business licenses. Opponents of expanding E-Verify argue that Congress prevented even the federal government from making E-Verify mandatory for all businesses and governments.
During a conference call with reporters last month after oral arguments were heard, David Selden, a Phoenix attorney for U.S. Chamber of Commerce, which opposes the law, said the most important argument under consideration is whether state and local governments are allowed to pass their own immigration-related laws and impose their own penalties by taking away the business licenses of those in violation.
"The question is whether we have one federal immigration law that applies in all 50 states that is enforced by the federal government and is applied the same way," he said, "or whether every state jumps in" with its own policies. "Under our constitution, it says federal law is the supreme law of the land. The question is then what will be the law for immigration." The decision could come down to whether the court decides that federal immigration law preempts state or local laws.
Selden said the federal Immigration Reform and Control Act, passed in 1986, generally preempts state laws that impose civil or criminal penalties for employers who hire undocumented workers.
"Then it has a little phrase that states in parenthesis 'except for licensing and similar laws.' Those are the magic words," he said. "The question then is, is the Arizona law and other laws being passed around the country that would take away business licenses — are those licensing laws or are those immigration laws?"
Bill Hammond, the president and chief executive officer of the Texas Association of Business, said the Constitution speaks for itself. The association opposes expanding the use of E-Verify.
"We consider immigration to be a national matter and renew our call on Congress to pass comprehensive immigration reform," he said. "We think and we hope that the Arizona bill will be declared unconstitutional by the Supreme Court because it is unconstitutional."
E-Verify does nothing to address more important employment issues like identity theft, Hammond said.
"Our first choice is for the [Texas] Legislature to leave this issue alone and perhaps pass a resolution or two memorializing Congress to get off the dime and pass a [comprehensive immigration reform] bill," he said.
Though they don't necessarily agree on how, lawmakers do agree something needs to be done soon.
"People are saying that [we] shouldn't be rewarding [undocumented immigrants] by giving them jobs. It's tough," Workman said.


text:
Home › dance › 'Seven Deadly Sins' coming back at the New York City Ballet Spring Gala
'Seven Deadly Sins' coming back at the New York City Ballet Spring Gala
6 May 2011 by gramilano Leave a Comment
Balanchine's ballet "Seven Deadly Sins," with Bertolt Brecht and Kurt Weil's libretto and score, was premièred by the New York City Ballet in 1958. Balanchine had created a first version of the work 25 years earlier for the Paris season of the short-lived Les Ballets 1933.
In the Paris production the dual role of Anna — a young woman who ventures on a geographically improbable tour of the United States with a new sin waiting in each city — was taken by Lotte Lenya, Weill's wife, and the dancer Tilly Losch. In 1958 Balanchine made use of the innocent beauty and dramatic talents of the young Allegra Kent, with Lenya again taking the part of the singing alter ego.
More than 40 years later "Seven Deadly Sins" is returning to City Ballet, but it is not a revival of the Balanchine work. The ballet has been choreographed by Lynne Taylor-Corbett.
The New York Times comments:
It's a testament to the fragile life of a dance that, despite the critical success of "Sins" in 1933 and 1958 ("a rare and marvelous piece of theater that nobody should miss," John Martin wrote of the later production in The New York Times), it faded from the repertory, almost without a trace.
"Perhaps 20 years ago it could have been put back together," Ms. Kent said in a telephone interview, adding that while she remembered her own part fairly well, there was such a complex series of entrances and exits that she had very little idea what other people had done.
It's astonishing to think that a critically acclaimed work created by Balanchine, Brecht and Weill (with the 1958 translation of the lyrics into English by W. H. Auden and Chester Kalman) could have left so little trace. But circumstances, and lack of routine filming of works at that time, seem to have conspired. Ms. Kent, who never had an understudy for the role, had just had a baby when Balanchine wanted to bring the piece back in the '60s. Later, Lenya wasn't available; nor was Barbra Streisand, whom Ms. Kent said Balanchine considered for her part. The vital transmission of a dance from one generation to another, in rehearsal and through physical memory, was lost.
There are many varied versions of the ballet by choreographers as diverse as Pina Bausch and Kenneth MacMillan. But Taylor-Corbett wanted to take the ballet back home, to the NYCB and thought that principal Wendy Whelan was ideal casting. It was her idea too to ask Broadway belter Patti LuPone to assume the singing role. LuPone was delighted:
I was really happy that Lynne came to me. Ever since I was very young I've never understood why I wasn't cast in more Brecht-Weill, because I thought I was suited to it. Now it's finally happening. When I was with the Acting Company, we spent summers in Saratoga, and I'd watch Gelsey Kirkland, Suzanne Farrell, Allegra Kent, Peter Martins. And I've been a huge fan of Wendy's for years. It's divine for me to be able to sing this with New York City Ballet now."
Photo: Patti LuPone and Wendy Whelan by Paul Kolnik
Filed Under: dance, music & opera Tagged With: Barbra Streisand, Brecht, George Balanchine, Kenneth MacMillan, New York City Ballet, Patti LuPone, Pina Bausch, Wendy Whelan
Daniela Dessi dies after a short illness, at 59
Renata Scotto on Maria Callas: greater than all of us
Alexander Pereira's partner Daniela de Souza on Zara and Wagner
Aged 97, Franco Zeffirelli will stage a new production of Rigoletto
Renata Scotto on slapping a tenor, the divine Callas, and… Bocelli
Mats Ek retires and pulls the plug on his choreography worldwide
Xander Parish on life with the Mariinsky Ballet
The extraordinary talent of Marianela Nuñez dominates Onegin at La Scala
Lindsay Kemp dies at 80
The tale of a dyslexic ballerina
How to stage a ballet... Maina Gielgud explains
My Big Fat Italian Ballet Gala
Interview with Joseph Caley, English National Ballet's new Principal Dancer

redpajama_set_name: RedPajamaCommonCrawl


text:
Il Governatorato Centrale è un ex governatorato del Bahrein con 303.918 abitanti (stima 2008). Il governatorato è stato soppresso nel 2014, e il suo territorio spartito tra i governatorati Settentrionale, Meridionale e della Capitale.

Il capoluogo del governatorato era Al Mintaqah al Wusta che è anche la città più popolata. Il governatorato era situato nel Nord del paese e confinava con altri governatorati del Bahrein come quello settentrionale, meridionale e quello della capitale. Il territorio è pianeggiante e viene bagnato dal mare solo a est nel golfo del Bahrein situato nel golfo Persico dell'Oceano Indiano.

Note

Collegamenti esterni

Centrale

redpajama_set_name: RedPajamaWikipedia


Cohesive products, also know as cold seal packaging products, are a pressure sensitive packaging system in which the material sticks to itself and not to the product being packaged. Cohesive packaging creates a strong, lightweight package that will reduce movement during shipping or handling and leaves no residue on the items being packaged. They lower labor and material costs because they reduce handling and eliminate taping, stapling or other means of fastening.


text:
Q: Swagger - how to get multiple operations with same http method and path but different content-type? as in the topic. I want to have different operations in swagger with same path and http method but with different content-type. Example:
I'm currently using Spring Boot in version 2.0.5  and Swagger ui in version 2.9.2.
In my API I have two methods to register user:
@RequestMapping(method = RequestMethod.POST, consumes = "application/customer+json", produces = MediaType.APPLICATION_JSON_VALUE)
@ApiOperation(value = "Registers a new application customer", notes = "Registers a new application customer.\n", response = CustomerResource.class)
@ApiResponses(value = {
        @ApiResponse(code = 201, message = "Customer successfully registered"),
        @ApiResponse(code = 409, message = "User with such email is already registered"),
        @ApiResponse(code = 422, message = "Customer registration request contains validation errors. Response contains detailed field validation error message"),
        @ApiResponse(code = 428, message = "Database error. Application log needs to be checked")})
public ResponseEntity<UserResource> registerCustomer(
        @ApiParam(value = "Model representation of the transferred data to register a new customer")  @Valid @RequestBody CustomerDto customerDto,
        UriComponentsBuilder uriComponentsBuilder,  BindingResult bindingResult)
{
...
}

and
@RequestMapping(method = RequestMethod.POST, consumes  = "application/partner+json", produces = MediaType.APPLICATION_JSON_VALUE)
@ApiOperation(value = "Registers a new application partner", notes = "Registers a new Easy Parking partner.\n", response = PartnerResource.class)
@ApiResponses(value = {
        @ApiResponse(code = 201, message = "Partner successfully registered"),
        @ApiResponse(code = 409, message = "User with such email is already registered"),
        @ApiResponse(code = 422, message = "Partner registration request contains validation errors. Response contains detailed field validation error message"),
        @ApiResponse(code = 428, message = "Database error. Application log needs to be checked")})
public ResponseEntity<UserResource> registerPartner(
        @ApiParam(value = "Model representation of the transferred data to register a new user")  @Valid @RequestBody PartnerDto partnerDto,
        UriComponentsBuilder uriComponentsBuilder, BindingResult bindingResult)
{ ... }

I want to have one POST path: /api/users to register two types of user: customer and partner. Two operations are required because partner has slightly different attributes than customer. I want to use content-type (consumes) to have different operations but swagger seems to work only with path and http method. Isn't it a bug?? Is there a way to configure it in Spring Boot Swagger?

redpajama_set_name: RedPajamaStackExchange


> time into researching it.
I don't know why I didn't give the link. Getting old. HERE.
I ain't no expert thats for sure, but I have had to read it, or parts of it, several times. Then I had to try and figure out the different versions to date them and it gets to be a big mess. Just understanding that is a field of study all to itself.
> god willin' and the crik don't rise.
And that's if Humbaba don't get you first.
> size of the forest were kind of a waste of time.
> little research first, or just ask.
Some people are just that way.
> a forest of giant trees.
Back in the day the cedar forest of Lebanon was much bigger. Considering the surrounding landscape of the Near East, the sight of such a magnificent forest was probably extra special.
Edited 1 time(s). Last edit at 15-Apr-18 02:36 by Thanos5150.


Two years of professional work experience (preferably in healthcare).
If the degree was earned outside of the U.S., it must be equivalent to a four-year U.S. baccalaureate degree.
Candidates who do not meet the 3.0 gpa requirement must submit a low gpa petition as part of the online application.
TOEFL scores may be required for applicants whose primary language is not English and for applicants with foreign degrees that were not instructed in English. Minimum accepted TOEFL scores: Paper-based (625), Internet-based (106), Computer-based (263). Scores should be sent directly from Educational Testing Services (ETS) to OHSU using TOEFL Code: 4865 (Oregon Hlth Sci U Sch Medicine).
Complete all four application sections (personal information, academic history, program materials, and supporting information).
Attach a current resume or curriculum vitae.
Answer the 500-700 word personal statement and attach as a pdf.
Provide contact information for two professional references.
Submit official transcripts from every college or university ever attended.
International transcripts may need to be evaluated by WES ICAP. Please consult the WES ICAP website for instructions and fees. Applicants are responsible for the full cost of the service.
Pay the $70 non-refundable application fee and submit the application for review.
Once a complete admissions file (online application, transcripts, test scores) has been received and reviewed, qualified candidates will be invited to interview in-person or via phone.
Have questions about the online application?
Please email or call customer service at 857-324-2017, Monday-Friday, 9 a.m.-- 5 p.m. (EST).
Applicants graduating from the Graduate Certificate in Healthcare Management who are planning on completing the M.S., please apply here.
Select the Healthcare Mngment-Masters application.
Admissions priority is given to applicants that complete the admissions process by the deadlines listed above. However, we reserve the right to review admissions files received after the above-listed deadlines, if space is available in the program.


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text:
Arnau Caldentey Riera (Manacor, 1 oktober 1981), voetbalnaam Arnau, is een Spaans profvoetballer. Hij speelt als middenvelder bij Atlético Baleares.

Arnau is afkomstig uit de jeugd (cantera) van FC Barcelona, hoewel hij eerder ook in de jeugdelftallen van RCD Mallorca speelde. Hij maakte zijn debuut in het eerste elftal op 22 april 2004 in een vriendschappelijke wedstrijd tegen het Chinees nationaal elftal (6-0 winst). Arnau verving na rust Oleguer Presas. Tijdens de voorbereiding voor het seizoen 2004/05 werd hij door Frank Rijkaard wederom bij het eerste elftal gehaald. Arnau speelde in de oefenwedstrijden tegen CD Banyoles, UE Figueres, Palamós FC, CF Hércules en CF Vilafranca. Zijn debuut in een officieel toernooi was op 15 november 2005, toen Arnau tegen Gimnàstic de Tarragona in de halve finale van de Copa Catalunya als vervanger voor Dani Fernández in het veld kwam. In het seizoen 2005/2006 was Arnau aanvoerder van Barça B.

In augustus 2006 verliet de middenvelder FC Barcelona en tekende een contract bij Sunderland FC uit de Engelse Football League Championship. Nadat Arnau in een halfjaar tijd slechts één competitiewedstrijd en één League Cup-duel speelde, werd hij eind november 2006 voor de rest van het seizoen verhuurd aan Southend United FC. In het seizoen 2007/2008 volgde een tweede verhuurperiode, ditmaal bij het Schotse Falkirk FC. Eind 2009 trok hij terug naar zijn vaderland waar hij ging voetballen bij Atlético Baleares.

Caldentey, Arnau


text:
Q: Does border always leave some space for content I need to address an accessibility issue where in the high contrast mode, my solid circle is not visible because the backgournd color gets removed. I tried to use border to fill the circle like in this: https://codepen.io/dala1/pen/oNGzdKb
.circle {
  height: 0;
  width: 0;
  border-width: 10px;
  border-style: solid;
  border-radius: 100%;
  border-color: red;
}

However, there is always a small empty hollow inside. Does the border always leave some space for content? Is there a way to remove the hollow?

A: Instead of making the border fill your circle, you can directly set the background color of the circle like so:

.circle {
  height: 100px;
  width: 100px;
  background-color: red;
  border-radius: 100%;
}
<div class="circle">
</div>

By using the border it may leave a circle in the middle if your circle diameter is larger that the border width combined. In this case, the solution is not to use the circle border to fill in the circle, but rather to set the circle's background color.

A: We can in increase the  border-width: 20px;. So it will the gap.


text:
Q: Intellij JSF ("h:") tags not displaying i am trying to run my first JSF Hello World Project in Intellij.
My Problem is that all JSF Tags like h: is not displaying in browser.
I do have mojarra 2.2.1 and JSF in my Project Structure
and I also have Tomcat 8.5.3 integrated in my Intellij Project
hello-world.xhtml
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE html
    PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
    "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml"
    xmlns:h="http://xmlns.jcp.org/jsf/html"
    xmlns:a="http://xmlns.jcp.org/jsf/passthrough">

<h:head>
    <title>Hello World</title>
</h:head>
<h:body>
   <h:outputText value="jhjhjhjhjj"/>
   <h:form>
       <h:inputText id="name" value="#{theUserName}" a:placeholder="What`s your name?"/>
       <h:commandButton value="Submit" action="myresponse"/>
   </h:form>
</h:body>
</html>

And here`s my web.xml:
<?xml version="1.0" encoding="UTF-8"?>
<web-app xmlns="http://xmlns.jcp.org/xml/ns/javaee"
         xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
         xsi:schemaLocation="http://xmlns.jcp.org/xml/ns/javaee                     http://xmlns.jcp.org/xml/ns/javaee/web-app_3_1.xsd"
     version="3.1">

<servlet>
    <servlet-name>FacesServlet</servlet-name>
    <servlet-class>
        javax.faces.webapp.FacesServlet
    </servlet-class>
    <load-on-startup>1</load-on-startup>
</servlet>
<servlet-mapping>
    <servlet-name>FacesServlet</servlet-name>
    <url-pattern>*.jsf</url-pattern>
</servlet-mapping>
<context-param>
    <param-name>javax.faces.PROJECT_STAGE</param-name>
    <param-value>Development</param-value>
</context-param>

</web-app>

I just had a look into the deployed index.xhtml which is in the out folder tomcat produces while deploying
and the following name spaces in the html tag are red highlighted
in there:
    xmlns:h="http://xmlns.jcp.org/jsf/html"

comes the message:
     "Resource is not registered by this is uri is not recognized
and for those two
  xmlns:ui="http://xmlns.jcp.org/jsf/facelets"
  xmlns:f="http://xmlns.jcp.org/jsf/core">

comes the message: URI is not registered. I tried to register them in the settings but its not possible.


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text:
<!DOCTYPE html>

<meta name="viewport" content="width=device-width, initial-scale=1">
<meta charset="UTF-8">
<title>Web Front End</title>
<base href="/" />

<link rel="stylesheet" href="lib/material-icons-local/material-icons.css" />

<link rel="stylesheet" href="bower_components/angular-material/angular-material.css" />
<link rel="stylesheet" href="lib/loading-bar/loading-bar.css" />
<link rel="stylesheet" href="css/roboto.css" />
<link rel="stylesheet" href="css/app.css" />

        <md-sidenav layout="column" class="md-sidenav-left ng-cloak" md-component-id="left" md-is-locked-open="$mdMedia('gt-md')">
            <md-toolbar>

LOGO HERE

            </md-toolbar>

            <md-list class="app-menu side-menu">
                <md-list-item ng-repeat="item in app.menu" ui-sref-active="active">
                    {{item.notification}}
                    <md-button ui-sref="{{item.state}}" ng-click="app.closeSideNav()">
                        <md-icon>{{item.icon}}</md-icon>
                        {{item.title}}
                    </md-button>
                </md-list-item>
            </md-list>
        </md-sidenav>
        <md-content flex ng-cloak id="mainContent">
            <md-content flex>

            </md-content>
        </md-content>

redpajama_set_name: RedPajamaGithub


text:
Q: Weird UI/Theme on Ubuntu 20.04 after upgrading from 18.04 I got this weird UI in Ubuntu after upgrading from 18.04. After running into an issue with a login loop I somehow managed to upgrade the distribution but got stuck with this UI/theme.

Does anyone know what the issue is?

A: You should reset the UI to the default with the following command
dconf reset -f /

As the dconf reset command will reset more than just the Unity, GNOME Shell and MATE desktop you should not run it idly and do make a backup of your existing desktop beforehand, especially if you've made extensive customisations and tweaks.
Run dconf dump.

A: I suppose you need to just to change the theme in gnome-tweaks.

*

*Open gnome-tweaks.

*Navigate to Appearance tab.

*Choose any theme you like.
You are done! Enjoy!


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Buy Or Sell: Diontae Johnson Will Set Franchise Rookie Record For Receptions
By Matthew Marczi
Posted on December 29, 2019 at 10:00 am
The offseason is inevitably a period of projection and speculation, which makes it the ideal time to ponder the hypotheticals that the Pittsburgh Steelers will face over the course of the next year, whether it is addressing free agency, the draft, performance on the field, or some more ephemeral topic.
That is what I will look to address in our Buy or Sell series. In each installment, I will introduce a topic statement and weigh some of the arguments for either buying it (meaning that you agree with it or expect it to be true) or selling it (meaning you disagree with it or expect it to be false).
The range of topics will be intentionally wide, from the general to the specific, from the immediate to that in the far future. And as we all tend to have an opinion on just about everything, I invite you to share your own each morning on the topic statement of the day.
Topic Statement: Diontae Johnson will set the team rookie record for the most receptions in a single season.
Explanation: Only one rookie in team history has ever caught 60 or more passes in a season, that being Troy Edwards in 1999 with 61. That is the team record. JuJu Smith-Schuster came close in 2017 with 58 receptions. Diontae Johnson is the only other rookie with 50 or more, currently at 55, and he would need seven receptions to break the record.
Johnson has been pretty hot lately, and heavily-targeted, relatively speaking. Over the past three games, he has been targeted 24 times and has caught 19 passes. He caught eight passes last week, the first game of his career in which he caught more than six passes (which he had done twice prior).
The Steelers will have no choice but to go all out to win today's game, and that means there's a good chance they're going to be throwing the ball around quite a bit. To be blunt, Johnson is the only starting receiver who is fully healthy, and he's also the best route runner, so that plays in his favor in terms of getting as many targets as possible. His nine targets last week was a career high, and he's only getting better.
Sell:
The fact that he has never had more than nine targets in a game, and never had more than six receptions in a game prior to last week, suggests that it's unlikely he's going to duplicate such a feat in consecutive weeks so quickly. He may get close, perhaps five or six receptions (he has caught at least five passes in six games), but seven is asking a lot, considering the circumstances.
The Steelers will be hoping, quite frankly, that they will be able to run the ball. And even if the Ravens rest some players in the secondary, they will still be a challenge to throw on. Marlon Humphrey will probably be out there, for one thing.
Related Items:Diontae Johnson
Diontae Johnson On 10 WRs Drafted Ahead Of Him: 'I Keep Track With Most Of Those Guys'
Steelers Ranked 9th Overall In Rick Gosselin's Special Teams Rankings For 2019
The Terrible Podcast – Talking Steelers 2019 Draft Class Recap, Wildcard Weekend, RB Need Rank, Listener Emails & More


The Middle East's "World War"
"WE SEEM TO be setting out on an uncertain mission with unclear objectives on an unknown timetable using ambiguous methods with unreliable allies." Those are the words of a supporter of president Obama and a prominent advocate of what's called humanitarian intervention, columnist Nicolas Kristof (New York Times, September 18).
Kristof is hardly the only one among Obama's friends who feels that way. Meanwhile, from the right wing, which wants to destroy this president, come demands for full-scale war complete with those infamous "boots on the ground" — as if the last U.S. invasion of Iraq, and Afghanistan before that, hadn't already left enough boots under the ground.
NEARLY TWO TIMES a week in the United States a white police officer kills a Black person during a seven-year period ending in 2012, according to the most recent accounts of justifiable homicide reported to the FBI.
IT HAS BEEN two years since the Chicago Teachers Union (CTU) struck for the first time in over 20 years and changed the discourse on education in the United States. The strike was historic in making issues of race and class central to a contract struggle and in garnering public support to defend public education.
The CTU strike confronted the attack on public education championed nationally by Arne Duncan, Obama's Secretary of Education, and the national forces in favor of privatization, from the hedge fund-backed Democrats for Education Reform to billionaires like Bill Gates and Eli Broad.
FINALLY, EVEN IF three decades too late, America's politicians are beginning to take notice of the fact that we have become the country on the planet locking up more people than any other.
THOUSANDS OF US who traveled to New York City to participate in the People's Climate March and the activities surrounding the Sunday, September 21st action have now returned home, organizing reportbacks and thinking about how this event pushed the movement forward.
Some have complained — both before the march and afterwards — that it was a symbolic action without official demands and heavy corporate funding, while others objected to the fact that we even marched away from the site of the one-day UN conference on climate change. However the march brought together something on the order of 400,000 people and more than 1500 participating organizations, all opposing the ineffective policies of governments, beginning with the United States.
"WE DO NOT like prisons, but they do not scare us," says Mahienour al-Masry, Egyptian lawyer and human rights activist who was serving a three year prison sentence for violating anti-protest laws before her recent release.
IN 2011, TAHRIR SQUARE was a space where Egyptian women found empowerment to reject the two models that previously limited their social role. In the Tahrir sit-in, women rejected the pseudo-liberation that invites women to only fight for their individual and personal freedoms, and opted to demand that they become active members of a society that continues to be based on exploitation and injustice, where freedom can only mean the freedom to be exploited, to exploit others and to consume to the best of our abilities.
IN A CASE that has sent shock waves through academia, the University of Illinois peremptorily cancelled the appointment of professor Steven Salaita to a tenured position in the American Indian Studies program at the university. After Salaita had resigned his previous position at Virginia Tech and uprooted his family, U-Illinois chancellor Phyllis Wise notified him that she would not present his appointment for approval to the Board of Trustees.
Wise took this action without any consultation with the American Indian Studies program, which has expressed outrage over this act of disrespect.
WHEN THE JIHADIST group Islamic State (formerly known as ISIS) changed its name and declared the establishment of the Caliphate, it did so with the release of a promotional video entitled "The End of Sykes-Picot." This was a reference to the 1916 Sykes-Picot Agreement that marked the end of the Ottoman Empire and the establishment of two zones of influence, British and French.
The current civil wars in Syria and Iraq, decades of conflict between Kurds in Iran, Iraq, Turkey, Syria and the central government in these countries, the establishment of the state of Israel and the Israeli-Palestinian conflict can all be traced back to that era. To understand the present situation in the Middle East we need to remember that with the exception of Egypt, most Arab states are recent creations, less than a century old.
AS AGAINST THE Current goes to press, the confrontation between the Hong Kong democracy movement and the Beijing-backed authorities remains unresolved.
The government's various attempts to end the occupation — to wait the students out, to rout them with pepper spray and clubs, to unleash criminal gangs in the guise of "angry citizens" — have failed. Protesters remain determined. Negotiations are scheduled for October 21, but whether they'll actually occur or produce any positive outcome is uncertain.
STARTING WITH THE foundations, the American political system, like its social order and economic structure, began as a New World variation of that in Britain. The United States constituted a republic of sorts, though the representative features of its government remained inherently weak, allowing coequal status to deliberately unrepresentative and unelected branches of government.
Almost immediately, a party system appeared, promising to deepen these representative features by offering voters input into the decision-making processes in giving them options at the polls. These parties would accomplish much of what they hoped, until the people cast ballots for serious and radical change — precipitating the fatal crisis of the 1860s.
New York: Columbia University Press, 2014, 368 pages, $35 hardback.
Chapel Hill: University of North Carolina Press, 2014, xiii, 233 pages, $29.95 paperback.
INTERNATIONAL SOLIDARITY HASN'T had a particularly good run recently, at least viewed from North America. The energy of the Occupy movement still circulates, but the sequel of the 2011 events remains uncertain, and the yield of the Arab Spring — never really a trans-hemispheric movement, in any case — is perhaps more ambiguous than ever.
New York: The New Press, 2014, 368 pages, $27.95 hardcover.
FOR HALF A century, historian Martin Duberman has been chronicling Black and LGBT lives and struggles from a radical left perspective. Several of his books, notably his masterful biography of Paul Robeson,(1) have linked anti-racism and sexuality in unexpected and illuminating ways.
Rowman & Littlefield, 2014, 362 pages, $29.95 paperback.
London: Verso, 2014, 288 pages, $29.95 paperback.
Durham: Duke University Press, 2013, 256 pages, $23.95 paperback.
RUBY DEE WAS a marvelously expressive actor, and a lifelong risk-taking radical committed to challenging racial and economic inequality. She made history as part of an extraordinary group of Black Arts radicals — including Paul Robeson, Lorraine Hansberry, Harry Belafonte, John O. Killens and Julian Mayfield, as well as her husband Ossie Davis — who actively protested white supremacy and thought deeply about the political implications of conventional racial representations, creating new stories and introducing new Black characters to convey deep truths about Black life.
RETIRED JUDGE CLAUDIA Morcom died August 21 at her Detroit home, following a battle with recurring brain cancer. She was revered in Detroit as a pioneer not only in the African-American freedom struggle, but also for women in the legal profession.


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Research Compliance and Assurance
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Research Compliance Assurance University of South Alabama AD 240Mobile, AL 36688 Ph: (251) 460-6308 srobbins@southalabama.edu
There are several definitions for a clinical trial. The University of South Alabama follows the definition provided by the National Institute of Health (NIH). Per the NIH, a clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. It is important to note that not all human subject research is considered a clinical trial.
If you are approached by a pharmaceutical company to conduct a clinical trial or if you want to develop an Investigator-Initiated clinical trials please contact the Director of Clinical Trials.
Wendy Blount, RN, MSN
Director, USA Health Clinical Trials
wlblount@health.southalabama.edu
▼ Regulations
Clinical trials that use a product that is regulated by the Food and Drug Administration (FDA) must follow FDA regulations. Additionally, clinical trials must adhere to the principles of Good Clinical Practice, most important of which is ICH E6: Good Clinical Practice- Consolidated Guidance. Below are important links to review prior to starting any clinical trials.
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
ICH Guidance Documents
ICH E6: Good Clinical Practice- Consolidated Guidance
The below information is vital information to conducting clinical trials at the University of South Alabama.
▼ Training
Personnel conducting clinical trials require additional training. Training requirements can be found on the Training webpage. All key personnel and investigators should take the required training. Key personnel are any research personnel that significantly contribute to the integrity of the research date. Examples of key personnel include coordinators and Investigators. Pharmacist should be considered key personnel when an investigational product is involved.
▼ Investigational New Drug (IND)
Numerous clinical trials that use a drug governed by the Food and Drug Administration (FDA) require an Investigational New Drug (IND) application to be filed with the FDA. The person or entity that files the IND is considered the Sponsor.
The Sponsor is ultimately responsible for all aspects of the study. Such responsibilities are clearly defined in the federal regulations.
University of South Alabama's Investigators should be sure to consider all the required Sponsor responsibilities before submitting an IND. Investigators should refer to the IND Guidance for comprehensive information about INDs.
▼ Data & Safety Monitoring for Clinical Trials
Data and safety monitoring is intended to protect the safety of research participants and ensure the integrity of the research data. All studies involving human subjects require some level of monitoring.
Federal regulations require appropriate provisions be in place to adequately monitor the data collected and ensure the safety of research subjects. The NIH requires data and safety monitoring for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); and efficacy, effectiveness, and comparative trials (phase III). The method and level of data and safety monitoring should be commensurate with the degree of risk of harm to subjects and the size and complexity of the study.
Data Safety Monitoring Plans (DSMP)
A DSMP is a written plan for monitoring research data and the safety of study participants. DSMPs are required for clinical studies involving more than minimal risk. A DSMP ordinarily appears in the study protocol and assures there is a plan and system for appropriate oversight of the study. The DSMP should delineate who is responsible for reviewing and reporting adverse events, to whom they will be reported, and on what schedule this monitoring and reporting will occur. The DSMP should also explicitly indicate whether or not there will be a formal data safety monitoring board (DSMB). Though every study involving more than minimal risk will have a DSMP, only a subset of studies will have a DSMB.
Data Safety Monitoring Board (DSMB)
A DSMB is a formally convened group charged with reviewing data and endpoints on a timeline set forth in a protocol's DSMP. These groups are made up of members from different disciplines who are knowledgeable and experienced in the responsible conduct of research. Membership must include experts in biostatistics and the medical field under study.
The following is a list criterion for the use of a DSMB:
Multi-site clinical trials with interventions that entail risk(s) to participants
If the trial is evaluating mortality or another major endpoint, such that inferiority of one treatment arm has safety as well as effectiveness implications.
Any research done in an emergency setting where the informed consent requirement is waived.
All phase III clinical trials with the exception of behavioral and nutritional studies
Phase I or II trials that involve blinding
The trial includes vulnerable population and is greater than minimal risk
When it would be ethically important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not yet fully addressed.
When there is prior information suggesting the possibility of serious toxicity with the study treatment
Studies that do not meet the above criteria, but are required by the funding source to be reviewed by a DSMB.
Investigators are required to report on the progress of the study at a frequency established in the DSMP and approved by the DSMB. Investigators should complete and submit the applicable form(s) listed under resources.
SOP 1206: Data Safety Monitoring Board policy
Reporting Forms:
Multi-Site Closed Session
Multi-Site Open Session
Single Site Closed Session
Single Site Open Session
▼ ClinicalTrials.gov
The Food and Drug Administration states that certain studies must be reported on the public website, clinicaltrials.gov. The submission requirements are outlined in Section 801 of the Food and Drug Administration Act (FDAAA 801) issued in 2007.
FDA Clinicaltrials.gov Resources
In September 2016, NIH issued a final policy to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Under this policy, every clinical trial funded in whole or in part by NIH is expected to be registered on ClinicalTrials.gov and have summary results information submitted and posted in a timely manner, whether subject to FDAAA 801or not. This policy is effective for applications for funding, including grants, other transactions, and contracts submitted on or after January 18, 2017. For the NIH intramural program, the policy applies to clinical trials initiated on or after January 18, 2017.
NIH News Release: HHS takes steps to provide more information about clinical trials to the public (September 16, 2016)
For Assistance with Clinicaltrials.gov reporting please contact:
Stefanie White, CCRP
Associate Director, Research Quality Assurance and Improvement
swhite@southalabama.edu
▼ Why it's important
Clinical trials must be placed in a public database, ClinicalTrials.gov, as mandated by federal agencies. The trials are required to be registered when they begin and updated throughout the life of the study. Additionally, study results must be provided upon completion of the study. Monetary penalties can be applied by the agencies if the requirements are not met.
▼ Recent changes – January 18, 2017
The revised requirements to register applicable clinical trials now also apply to trials funded by NIH, whether they or not they are FDA-regulated. The expanded regulations also include increased penalties for noncompliance. Furthermore, several scientific journals have specified they will not publish clinical trials which have not registered.
▼ Applicable Clinical Trials
Clinical trials funded by in whole, or in part, by National Institute of Health
Definition of Clinical Trial as determined by the NIH:
A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
This definition encompasses phase 1 trials of FDA-regulated drug and biological products, small feasibility studies of FDA-regulated device products, and study of any intervention not regulated by the FDA, (i.e., behavioral interventions)
Trials that meet the clinical trial definition of the International Committee of Medical Journal Editors (ICMJE) that the investigator may publish.
Definition as determined by ICJME:
Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. NOTE: Registration must occur before the first patient was enrolled.
Qualifying clinical trials that will render claims for items/services to the Center for Medicare and Medicaid Services.
The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.
Definition of a Qualifying Clinical Trial under CMS Clinical Trials Policy:
The subject or purpose of the trial is the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
The trial is not designed exclusively to test toxicity or disease pathophysiology and must have therapeutic intent.
Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers, although trials of diagnostic interventions may enroll healthy patients to have a proper control group.
Applicable Clinical Trials per FDAAA:
Trials of Drugs/Biologics: Controlled, clinical investigations of a product subject to FDA regulations, other than Phase I. This may include interventional studies with dietary supplements.
Trials of Devices: Prospective controlled trials with health outcomes, which compares an intervention with a device against a control, other than small feasibility studies. Includes Pediatric post-market surveillance studies.
Applicable Clinical Trials under FDAAA also meet one of the following conditions:
Checklist for Evaluating whether a Clinical Trial or Study is an Applicable Clinical Trial
The trial has one or more sites in the U.S.
The trial is conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) application
The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research
FDAAA requirements for registration exclude the following (unless funded either in whole, or in part by NIH):
(Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as research tools to explore biological phenomena or disease processes
Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
Non-interventional (observational) clinical research, such as cohort or case control studies
▼ Who is the Responsible Party for Registering Trial and Study Results?
The responsible party is considered to the study sponsor (i.e, IND or IDE holder or the initiator of the study) or a sponsor-designated PI who is responsible for conducting the study, and has access to and control over the clinical data to analyze the data and publish the results.
The USA PI should consult with industry sponsor to assure that posting of a trial is in accordance with terms of the study contract. A sponsor whom provides study drug only typically does not accept the registration/results reporting responsibilities.
▼ Registration and Reporting Results
ClinicalTrials.gov Registration Guide
Initial Registration: No later than 21 days after enrollment of first subject
Interim updates: The record must be updated annually (even if nothing has changed) until the final results are reported. NOTE: Specific type of changes must be reported within 30 days.
Reporting Results: No later than one year after the trial's primary completion date. This is the date when the final subject was examined or received an intervention for the purposes of collection of data for primary outcomes.
▼ What specific information is provided to Clinical Trials.gov?
Specific information on the data elements required by FDA and NIH for registration reporting is located on the ClinicalTrials.gov Protocol Registration System information website.
Data elements for protocol registration
Data elements for results reporting
▼ Responsibilities of the PI
The PI can delegate the responsibility for entering information for purposes of registration, updates and reporting of results, however, the PI remains responsible for:
The accuracy of the information
The Approve and Release actions which are required every time information is entered into the record
▼ Informed Consent Requirements
Federal regulations require that consent forms included the following statement, without revision. This is included in the USA standard consent template:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
▼ Penalties for failure to register a clinical trial
Failure to register, or provide incomplete/false information (including updates subsequent to initial registration) may include monetary penalties of up to $10,000 per incident and/or per day, non-compliance notification from the FDA, and for federal sponsored studies, the withholding or recovery of grant funding.
NIH grantees are required to certify compliance with registration/reporting requirements in grant applications and progress reports.
▼ Resources
Summary of Changes effective January 18, 2017
www.ClinicalTrials.gov
ClinicalTrials.gov FAQs
Clinical Trials.gov Protocol Registration System
Results Reporting - Checklists, Templates, and Examples
FAQs for NIH Grantees
NIH Implementation of FDAAA
▼ Investigator-Initiated Clinical Trials
Investigator-Initiated Studies (IIS), also called Investigator-Initiated Trial (IIT), are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators or institutions. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations.
Investigators should contact the Director of Clinical Trials for assistance with study development.
Maintaining compliance can be a challenge since these trials are not overseen by a sponsor and monitoring team. The Office of Research Compliance and Assurance have tools, guidance, practices that can help you at all time-points of your study. For assistance with monitoring of Investigator-Initiated studies please contact:
Below are the steps that you need to take to start-up and manage an IIS trial. Some steps can be done simultaneously, while others need to be done chronologically.
▼ STEP 1: WRITE THE PROTOCOL
Below is a link to a protocol template. It is not required that you use this template. Clinical research protocol templates are widely available on the internet. E6(R2) Good Clinical Practice: Integrated Addendum[BW3] outlines the necessary information for a clinical trial protocol and protocol amendments in section 6. It is highly suggested that your compare your finished protocol with section 6 of the above guidance to ensure that all components of the protocol are described.
Protocol Template
▼ STEP 2: DETERMINE THE FEASIBILITY
It is vital that the logistics and the feasibility be assessed for an IIS. Protocols should be sent to the following individuals to determine the feasibility of an IIS protocol:
Winona (Wendy) Blount, RN, MSN
USA Health Clinical Trials Office
Assoc. Director, Research Quality Assurance and Improvement
Office of Research Compliance and Assurance
Principal Investigator's should also start discussing the protocol with departments that they plan to utilize. These departments will also be able to provide feedback on the feasibility of the protocol.
▼ STEP 3: DETERMINE THE BUDGET
This step can be started while the feasibility step is in progress. However, the budget should not be finalized until Step 2 has been completed.
The budget will vary greatly from study to study and will depend on numerous factors. Please contact Wendy Blount for assistance with developing your study budget.
(251)445-9834 office
▼ STEP 4: DETERMINE IF AN IND OR IDE IS NEEDED
Investigational New Drug (IND)- The United States Food and Drug Administration's Investigational New Drug program is the means by which a Sponsor (the person who takes responsibility for the study and drug- NOT the funding source) obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved.
Please refer to the IND Guide Book for information on conducting a study with an IND.
Investigational Device Exemption (IDE)- allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a 510(k) submission to Food and Drug Administration (FDA).
INVESTIGATIONAL DRUGS - IND
INVESTIGATIONAL DEVICES - IDE
FDA REGULATIONS 21 CFR 312 21 CFR 812
GUIDANCE/RESOURCES Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND (FDA Guidance)
FDA Website Significant Risk and Nonsignificant Risk Medical Device Studies (FDA Information Sheet; Includes examples of SR and NSR devices)
FDA Website
INITIAL FDA PAPERWORK FOR APPLICATIONS
IND Application: Instructions in 21 CFR 312.22-23
Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs) (FDA Guidance)
FDA Form 1571 (IND Application Cover Form): Form ( PDF) | Instructions
FDA Form 1572, Statement from Investigator: Form(PDF) | FAQ - Statement of Investigator (FDA Guidance)
FDA Form 3674, Certificate of Compliance: Form (PDF)
Register the study on ClinicalTrials.gov.
If applicable, a written request for charging the cost of the investigational drug to subjects
Conflicts of interest (financial disclosures) for all participating investigators
Financial Disclosure by Clinical Investigators (FDA Guidance)
The FDA paperwork is not required to be submitted to the IRB. After submission, the FDA will respond within 30 days. All documentation received from the FDA must be kept on file.
IDE Application: Instructions in 21 CFR 812.20
IDE Approval Process( FDA Guidance)
FDA Form 3674, Certificate of Compliance: Form( PDF)
Sponsor-Investigators are encouraged to contact the FDA to obtain further guidance prior to the submission of an IDE application through the Pre-IDE Submission Process.
This step can be done at the same time as STEP 3. It is advised to wait until STEP 2, the feasibility assessment, is complete as it can result in changes to the protocol.
▼ STEP 5: COMPLETE REGULATORY DOCUMENTS
The following documents should be created.
Informed Consent Form- Please refer to the Informed Consent page for more information on creating the Informed Consent.
Case Report Forms- The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. The CRFs can be electronic or paper. These forms should collect data points that support the objective(s) of the study, as well as, gather data for subject safety.
Advertisement- Create any advertisements you plan to use for your study. These will need to be approved by the IRB
▼ STEP 6: SUBMIT TO THE IRB AND OTHER REGULATORY BOARDS
All research involving human subject must be approved by the Institutional Review Board BEFORE you enroll any subjects or gather any data. Any IIS research must go through the University of South Alabama IRB; it cannot go through WIRB.
For more information on how to submit to the IRB, please review the Getting Started section of the Research Compliance and Assurance's webpage.
Please review the Getting Started section of the Biosafety webpage to see if your study requires IBC approval.
Data Safety Monitoring Board
A Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises the sponsor and the study investigators. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations. The DSMB evaluates research data on an ongoing basis to assure participant safety and study integrity. The DSMB periodically reviews study data and unanticipated problems and makes recommendations based on their reviews along with assessing the performance of overall study operations and any other relevant issues, as necessary. The following is a list criterion for the use of a DSMB:
If you have any questions about using a DSMB or if you need assistance determining if your study requires a DSMB, please contact:
▼ STEP 7: REPORT ON CLINICALTRIALS.GOV
More information to come. Please contact Stefanie White for more information.
Stefanie White, CCRP Associate Director, Research Quality Assurance and Improvement


The following press statement was issued by Detroit Branch NAACP President Rev. Dr. Wendell Anthony.
DETROIT (July 10, 2018) – The Coalition led by the Detroit Branch NAACP which includes Grand Rapids Branch NAACP, Michigan State Conference NAACP, Michigan Conference United Church of Christ, Arab American Civil Rights League (ACRL), ACLU of Michigan, Greater Lansing Clergy Forum, LA SED, Progressive National Baptist Convention, UAW Region 1D, and LEAD Michigan supports the recent efforts of the Bethany Christian Center to re-unite children under 5 with their families. This coalition made a trip to Grand Rapids on June 27th to protest the separation of children from their families at the border by the Trump administration. It also included a sit-down discussion with officials at the Bethany Christian Center on the need to re-unite all children. The Federal court has determined that children under 5 must be re-united with their families as of July 10th. The Trump administration is seeking an extension due to the fact that they are unable to identify parent and child. In the words of a mother separated from her child at the border, "Why was it so easy to take my child from me and yet so hard for you to bring my child back to me?" This evil incompetence on the part of the Trump administration reflects the malfunction in the very heart of the American spirit.
Click the link Press Statement — Let's Reunite Parents and Children Now to read the statement in its entirety.


May 17, 2017 — Rockwell Automation has announced that the overall winner of its inaugural Best Future Machine Award is Italian company Cama Group.
The competition – created to recognize and reward the high levels of innovation in the packaging industry – was split into five categories: ease of use, modular machines, smart machines, sustainability, and traceability and product safety.
The final shortlist and eventual winners were chosen by a prestigious judging panel comprising representatives from four international manufacturers: Johnson & Johnson, Proctor & Gamble, Kimberly Clark and Nestlé; and two major European trade associations: UCIMA and GEPPIA.
Cama Group is known globally for the technology and reliability of its packaging systems. The packaging machines and robotized lines – designed, manufactured and installed by the Italian company worldwide – can be used in food and other industries. They cover the whole primary and secondary packaging processes, from the line entrance to the end-of-line packaging operations before palletizing.
The award-winning machine is the company's IF318 robotized monoblock loading unit. The machine also leverages the iTRAK intelligent track system from Rockwell Automation.
Cama rated highly in several categories and won best ease-of-use. The Cama machine showed how an integrated, modular design concept can be incredibly flexible and suit multiple applications.
Modular Machines: Gebo Cermex's modular CareSelect infeed system stood out for its product handling, where movers are only in contact with a bottle for 0.3 seconds.
Smart Machines: Goglio won with its GCap6 filling machine for aluminum capsules. The judges were impressed with machine's remote-access capabilities and its use of Connected Enterprise technologies.
Sustainability: The judges awarded CMC Machinery the winner in the sustainability category for its CartonPack box-on-demand solution, which produces optimum box sizes with minimal packaging waste.
Traceability and Product Safety: SN Maschinenbau's FM 200 pouch packaging machine's communication capabilities was designed with Industrie 4.0 in mind and offers data-capture possibilities for traceability.
The winners were announced at a ceremony held on the Rockwell Automation stand on the first day of the interpack show. Cama will be given free flights and hotel accommodations to the Rockwell Automation Automation Fair event, Nov. 15 and 16 at the George R. Brown Convention Center in Houston. While at the event, Cama representatives will have the opportunity to meet senior management teams and key industry personnel from the U.S.


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  var Muuri = window.Muuri;

  QUnit.module('Grid methods');

  QUnit.test('getElement: should return the container element', function (assert) {
    assert.expect(1);

    var container = utils.createGridElements();
    var grid = new Muuri(container);
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      container.parentNode.removeChild(container);
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  });
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Hello and welcome! I'm Andrea Reiser and while I call myself a happiness coach, author and speaker, others refer to me as a "life brightener," "happiness cheerleader" or "inspiring dose of sunshine." Having studied positive psychology and the science of happiness, as well as trained as a life coach, I know that each of us is in charge of our own happiness, and it's my pleasure to share with you messages of motivation and encouragement.
On the professional side, I have a B.S. in Mass Communication/Public Relations from Boston University, and I'm a member of the American Society of Journalists and Authors. My most recent book, The Happy Book: 50 Rays of Sunshine To Brighten Your Day (PickleStar Press, 2018), is a colorful gift book I created with 50 of the most popular quotes I have designed for my large happiness community on Facebook. My earlier book, Letters From Home: A Wake-Up Call for Success & Wealth (Wiley, 2010), has been described as "required reading for all parents," and a "blueprint for raising healthy, happy, productive, and loving children." A contributor to The Huffington Post, I've written for and been interviewed in a variety of print and online publications including Woman's Day, Parents.com, Care.com, Chicago Tribune, and The Stir. I've appeared on Fox Business and News12 CT, as well as on dozens of radio shows across the country.
On the personal side, I've been married since 1993 to the same guy who proposed just seven weeks after we met (see 29 Things I'm Grateful For On Our 20th Anniversary), and I'm the proud mom of four sons, including identical twins, who are all in college and beyond. I had a preventive mastectomy in 2007 after I lost my mom to breast cancer and learned I carried the BRCA-1 gene mutation (read more in They're ALMOST Real, And They're Spectacular), and I'm always happy to talk to other women facing a similar decision. I adore Broadway theatre, especially musicals (recent favorites include The Band's Visit, Hello, Dolly!, Three Tall Women, Come From Away, Hamilton, The King & I, The Audience and Something Rotten). And don't groan, but my lifelong guilty pleasure is the music of Barry Manilow (you'll get why in Barry Manilow: My Musical Comfort Food). In my spare time I'm on a never-ending quest to create the world's yummiest chocolate chip cookie. Home for me is New York City, as well as by the beautiful beach where I grew up in Narragansett, Rhode Island.


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UN General Assembly renews long-standing call for end to US embargo against Cuba
UN Photo/Evan Schneider
Results of the General Assembly vote on the draft resolution entitled "Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba."
1 November 2018 Economic Development
The United Nations General Assembly has overwhelmingly voted in favour of condemning the United States economic, commercial and financial embargo against Cuba - a call it has made every year since 1992.
A total of 189 UN Member States voted in favour, with Israel and the US voting against the resolution, urging all States to "refrain from promulgating and applying laws and measures" which among other things, in the case of the embargo, interfere with the freedom of trade and navigation. There were no abstentions.
The Assembly called upon States "that have and continue to apply such laws and measures to take the steps necessary to repeal or invalidate them as soon as possible."
Through the resolution, the General Assembly also decided to include the agenda item entitled "Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba," in the provisional agenda of next year's session.
The vote on the resolution is unenforceable, but the Cuban-sponsored resolution shines a spotlight on the relative isolation of the US regarding the embargo, which was first imposed in 1960, when former leader Fidel Castro came to power, following the revolution.
Speaking ahead of the vote, Cuba's Foreign Minister Bruno Rodriguez Parrilla outlined the impact of the embargo on Cubans, especially due to restrictions on lifesaving medicines. "Incalculable human damage has been caused by the blockade, which is qualified as an act of genocide" he said, referring to the convention on the prevention of genocide. "It is also a violation of International Humanitarian Law, if it were a conflict," he said.
Before the resolution was adopted, eight amendments, relating to the Sustainable Development Goals (SDGs), human rights and rule of law, proposed by the US, failed to pass (see here for voting details).
Introducing the amendments, US Ambassador Nikki Haley said that the draft resolution "changes nothing" in terms of addressing the problems faced by Cuban citizens. "The United States will continue to stand with the Cuban people, until their rights and freedoms are restored. We won't back down," she said.
Member States who spoke on the resolution over two days, overwhelmingly called on the US to end the embargo and other punitive measures against Cuba.
National representatives said that the nearly six‑decades‑long blockade imposed on the Caribbean island by Washington impeded its right to development and its ability to participate fully in the global economy. They also urged the US to heed the Assembly's repeated calls to lift its restrictive policies.
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US abstains for first time in annual UN vote on ending embargo against Cuba
In Cuba, UN chief stresses Latin America's courageous 'development vision'
Cuba: UN Members overwhelmingly support end of US embargo, as Brazil backs Washington
News Tracker: Past Stories on This Issue
UN General Assembly again calls for lifting US embargo against Cuba
The United Nations General Assembly on Wednesday adopted a resolution underlining the need to end the economic, commercial and financial embargo imposed by the United States against Cuba.
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This refillable palette consists of four shades and one pressed HD powder to illuminate the complexion and highlight the face's assets. It comes in two complexion types (fair to medium-tanned and medium-tanned to dark) in a powder texture. Suitable for all skin types, this is the must have palette.


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Fotor is one of the top all-in-one photo editing Apps, which was stated as the ?lite Photoshop? by BBC. This is the perfect app for all your photography requirements. With this app, you can show your talent to 100 million users within the Fotor community. Windows 8 users can experience the advanced tools including outstanding visual effects, basic editing tools, one-tap enhance, frames, text, collage, Raw Converter and Tilt Shift. This one-stop photo sharing, editing, and sale app is loaded with powerful features.
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