The mission of the Regulatory Affairs Department is to gain approval from the Institutional Review Board(s) so that patients may be enrolled in investigational studies provided by START.

The Regulatory Affairs Department follows FDA and GCP guidelines for every study to ensure all federal and industry requirements are met. Computerized systems are accessible by all members of the organization so they have the most current information regarding studies at any given time. For sponsors, the department handles the processing of 1572s, maintaining current investigators’ CVs and medical licenses, financial disclosure forms, delegation of authority logs, and current laboratory certifications and normal ranges. Other responsibilities include drafting informed consent documents and submission of adverse event reports, protocol amendments, revised consent forms, continuing review reports, investigator’s drug brochures, and IND Safety Reports to the IRB. In addition, Regulatory Affairs maintains a study database with various information about each study and a study archives database.

IntegReview Ethical Review Board (ERB) has jurisdiction for all START clinical studies. Information regarding IntegReview ERB is as follows:

IntegReview Ethical Review Board
3001 S. Lamar Blvd., Suite 210
Austin, TX 78704
Telephone Number: 512-326-3001
Fax Number: 512-326-3446
Website: www.integreview.com

IntegReview, Inc. Ethical Review Board is registered with OHRP as the Parent Organization and its identification number is IORG0000689 with an expiration date of June 25, 2010. IntegReview consists of 4 Boards and their registration identification numbers are:

IntegReview, Inc. Ethical Review Board IRB #1: IRB00001035
IntegReview, Inc. Ethical Review Board IRB #2: IRB00003657
IntegReview, Inc. Ethical Review Board IRB #3: IRB00004920
IntegReview, Inc. Ethical Review Board IRB #4: IRB00006075

Submission deadlines to the IRB for new studies are always at noon (CST) on Wednesdays. Those items get reviewed the following week on Tuesday at one of the board meetings. An e-mail gets sent to the study usually within 24 hours after the meeting with notification of board’s decision (approval or items that need to be address). If the study was approved at the meeting, approval documents are placed on the internal, secure Web Board as PDF documents within 48 hours after the meeting. If items need to be addressed, a response can be submitted at anytime and it will be reviewed at the next IRB meeting.

Once a study is approved, any study items that require IRB review can be submitted to the IRB at any time. If the item qualifies for expedited review, it will be reviewed and approval documents distributed within 48 hours from receipt. If a study item requires full board review, it will be reviewed at the next scheduled meeting and approval documents distributed within 48 hours from the meeting.