November and December IRB deadlines/meeting dates have changed. Please review the new deadlines and meeting dates. Laurel Hermanson, IRB Coordinator for Panel Two, has transitioned to a part-time role. Lisa Rigtrup, IRB Coordinator, will join the office September 14.
Read MoreWhen submitting amendments (or applications for continuing review that include an amendment) that update the Investigator’s Brochure (IB) to include new risks, please remember to update the Investigational Drug Data Form (IDDF). This can be done using the ‘Update Study’ ERICA process after completing the amendment application. The IDDF is an important tool used as […]
Read MoreDr. Hurdle has stepped down as IRB Chair in order to prepare for his upcoming visiting scholar’s fellowship at the NIH. If you have an IRB matter that requires the attention of the Chair, such as reporting a deviation or a study participant fatality, please contact Susan Howe, IRB Compliance Administrator. The IRB would like […]
Read MoreDue to the number of submissions that require full board review, some IRB applications will be bumped back one board meeting. This includes continuing reviews, amendments, and new studies. We apologize for any inconvenience and hope to be back on the regular review schedule by the end of August. Please contact the IRB to learn […]
Read MoreFor studies involving IND’s, the IRB now requires the FDA 1572 Form and the FDA Letter of Receipt of the IND. These should be attached in the Other Documents section of the ERICA ‘Documents and Attachments’ page. The Department of Pharmacy Services Policies and Procedures has been posted under Guidelines. Please review these policies to […]
Read MoreWe have changed the August 2006 submission deadlines and board meeting dates. Please refer to our Deadlines to avoid delays in the review process. The board will not meet August 2, 2006.
Read MoreThe Clinical Trials Facilitator now requires a Patient Care Classification Form be completed to clarify costs of standard-of-care procedures versus research-related procedures. If you are required to complete this form for the research project, it will be requested as an attachment in all IRB new study applications and continuing review applications. You will be reminded […]
Read MoreLacy Clegg is our new IRB coordinator for Panel 3. Her first day is March 27 th . Please help us welcome her to our staff! IRB Requirements: A reminder that for studies involving INDs the IRB now requires the FDA 1572 Form as well as the FDA Letter of Receipt of the IND. These should […]
Read MoreThe IRB is working to complete our response to the AAHRPP site visit recommendations. A number of documents, templates, and ERICA processes will be modified as part of this process. We will post all changes and additions on the News and Announcements page of our web site as they become available.
Read MoreThe Principal Investigator’s conflict of interest disclosure number (CoI number) for a project must be provided for IRB new study and renewal applications. If a CoI number is not provided, the application will not be accepted by the ERICA system. Please contact the Conflict of Interest Office – 801-581-6351 – for more information.
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