The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval.'' The guidance announced in this document finalizes the draft guidance of the same title dated January 2010. This document also supersedes the Information Sheet, Continuing Review After Study Approval. The guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.
Crystal Arensdorf time line 2001 July 3: Crystal Arensdorf, 20, enters Knicker's Saloon, 2186 Central Ave. July 4: At approximately 2 a.m., Arensdorf goes missing. July 13: City and county investigators chase about 100 leads. Arensdorf's family posts more than 3,000 fliers around the tri-state area. Reward grows to $5,000. 2002 Feb. 1: Crystal Arensdorf's 21st birthday. Police follow 450 leads. March 25-28: Arensdorf's sisters travel to New York to tape an episode of "The Montel Williams Show," where psychic Sylvia Browne tells them their sister is in Washington, D.C., with a man. Browne says Arensdorf will contact her family before Christmas. April 11: Police say two brothers were at Knicker's when Arensdorf was last seen and they have inconsistent stories. The brothers, who denied an...
A month after Mason County commissioners voted against a Charleston developer's plan to build an apartment complex on land owned by West Virginia Treasurer John Perdue, a state housing agency board that Perdue serves on approved changes that paved the way for the $3.67 million project to be funded and constructed, records show. In May 2009, Mason County commissioners voted unanimously against a request from Perdue and developer Douglas E. Pauley to issue a letter to the West Virginia Housing Development Fund supporting - or not taking a position on - Pauley's proposed apartment complex for seniors and the disabled near Point Pleasant.
Rescue teams from the federal government clashed bitterly with Massey Energy officials about how to safely search the Upper Big Branch Mine for potential survivors in the hours after a huge explosion in April 2010, according to previously confidential records obtained by the Gazette-Mail. S. Mine Safety and Health Administration rescuers were worried about the lack of backup teams as they combed the sprawling underground mine, amid concerns about the possibility of additional blasts and other dangerous conditions.
Two Colorado Springs SWAT officers were disciplined after an Oct. 12 incident in which a distraught drug suspect died after bailing out of their moving police vehicle and running into traffic on Interstate 25, police said. Officers Carlos Sandoval and John Havenar failed to follow the department's prisoner transport policy, said Colorado Springs police spokesman Sgt. Steve Noblitt, summarizing an internal affairs investigation.
Kennebunkport's police chief has retired after an investigation into his conduct on Feb. 11, when he was pulled over by one of his own officers who suspected him of driving under the influence. Joseph Bruni was not arrested or issued a summons to appear in court, but was - after a heated disagreement - driven home. Afterward, officers alerted the town manager, who began an internal investigation.
MEXICO CITY -- The Vatican on Saturday ordered the overhaul of one of the Catholic Church's largest and most influential organizations following an investigation into decades of sexual abuse by the group's founder and systematic efforts to cover it up. Mexican-born Father Marcial Maciel engaged in "very serious and objectively immoral behavior," the Vatican said -- including fathering at least one child and sexually molesting boys and seminarians. The abuse dates to the 1950s and continued into the 1990s, years in which Maciel led a double life, protected by silence and obedience and his ability to sideline his accusers.
TAMPA, Fla. | South Florida fired football coach Jim Leavitt on Friday, after a school investigation concluded he grabbed one of his players by the throat, slapped him in the face and then lied about it. A report on the three-week probe said the university's findings were based on "independently corroborated statements of persons found to be in the best position to observe your conduct.
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