COAST IRB

Letter from FDA - Dated 6-4-2009

June 3, 2009

URGENT - Update on Coast IRB closure!

Dear Clinical

Study Manager/Associate,

This is notification that Coast IRB will be closing it doors and ceasing operations as of June 30, 2009. To avoid termination or a gap in oversight, Coast IRB urges you to take appropriate measures to ensure the clinical study you are engaged in is transferred to a new IRB no later than June 22, 2009.

Coast IRB will be conducting its last Board meeting on June 25, 2009. Any sites that have not submitted all items for review, including Close-out Reports and Safety Reports, by 5:00pm MST on June 22, 2009 will be administratively closed.

We respectfully request that if you have any sites not yet approved by the transfer IRB, please forward this information appropriately. We would greatly appreciate any assistance you can provide in facilitating site transfer.

Failure to meet the above listed deadline could provoke FDA involvement at the site or Sponsor level. This involvement could lead to termination or suspension of the study if the FDA believes that there are safety or review issues. To avoid such regulatory agency involvement, please ensure that your study/site has either been closed or successfully transferred.

Please be aware that the FDA is actively monitoring our transfer process.

Respectfully,

Coast IRB, LLC


May 28, 2009

The following is a letter from the FDA regarding IRBs conducting de novo review and record retention for Coast IRB study files. This letter is posted at the request of the FDA. Coast makes no representations regarding the statements made by the FDA in the letter and anyone relying on the contents of the letter does so at his, her, or its own risk.

Letter from FDA - Dated 5-26-2009
PDF. File size: 369k

April 29, 2009

- Coast remains under an FDA suspension that prohibits it from reviewing any new studies or approving any new subject enrollments. 

- Coast continues to convene IRB meetings to, among other things, review safety related data and processing continuing review (CR), close out reports and any miscellaneous study review items such as site address changes and the like.

- Coast has selected Chesapeake Research Review, Inc.,  as the designated IRB to transfer Coast's studies for continued  monitoring and IRB oversight. Coast anticipates that this transfer may take approximately 4-6 weeks to complete.   Please note that only studies in which clients have elected to use Chesapeake will be transferred to Chesapeake for its review and decision on acceptance.  All other studies will be transferred according to client's preferences. Chesapeake has designated Ms. Theresa Straut and Ms. Amy Schwarzhoff at 410-884-2900 as its point people for Coast transfer.

- With respect to each transfer, Coast will use a transfer form which will be completed by both Coast and the client to document the transfer and identify data needed to complete the transfer.  Coast will expeditiously process transfer requests and provide administrative support as necessary for each client.

- At this time, the remaining Coast employees (8) are working urgently to communicate with all Sponsors/CROs and sites to determine study destination and help facilitate the transition process.

- Cost factors associated with the transfer will be handled after the study has been officially transferred. Coast will offset the transfer cost by comparing the current invoicing balance for each client. 

- FDA has been on-site and has been updated on the current study transfer progress. FDA will receive confirmation that all studies have been transferred.

- Coast prefers to send all clients their study documents and will maintain the documents until they have been shipped. Confirmation that study documents have been received is mandatory. No study files will be destroyed.

<Posted April 15, 2009>

On April 14, 2009, the Food and Drug Administration issued a warning letter to Coast IRB. Pursuant to the letter, Coast will provide the agency with a corrective action plan on or before April 29, 2009.

In that vein, Coast has voluntarily agreed to adopt two restrictions pending FDA approval of its corrective action plan.

Until further notice: (1) Coast IRB will not approve any new studies subject to the requirements of 21 CFR Part 56 and (2) no new subjects will be added to on-going studies subject to 21 CFR Part 56.

Coast IRB is cooperating fully with the Food and Drug Administration to implement corrective actions to bring the company into compliance with FDA regulations designed to protect human research subjects. The reforms undertaken by Coast are sweeping, designed to exceed the level of protection required by existing law. A new board chair and new board members will be put in place promptly. New standard operating procedures developed by former FDA clinical investigators are being implemented to ensure maximum protection for human subjects. Those same experts are scheduled to provide training in implementing the new SOPs to Coast's review staff and its new board. Coast will make internal audits commonplace to guard against risks to human subjects. "Coast IRB is changing everything,” said Coast CEO Dan Dueber. “We are revamping every aspect of the company.”

For additional information pertaining to your study specifically, cservice@coastirb.com or call (719) 325-8826.