« Return to News | Ethics/Regulatory

Coast IRB Halts New Study Submissions

Wednesday, April 15, 2009 07:53 AM

Facing FDA concerns about its ability to protect human subjects participating in clinical trials, Coast Institutional Review Board has voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies.

These actions may involve up to 300 active trials conducted by 3,000 clinical investigators, the FDA announced yesterday. Studies that Coast IRB already has approved will be permitted to continue but no new patients will be enrolled.

Coast, which was recently the target of an undercover investigation by the Government Accountability Office, received a warning letter from the FDA outlining five “serious violations” and calling for reform.

Coast announced last week a 30-day suspension of the processing of new study submissions and has hired a consulting firm to audit its operations, SOPs and forms. Coast has said it will return to the FDA with a corrective action plan by the end of this month.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.