A number of revised templates and resources have been posted on the IRB web site. Protocol Summary Template New Protocol Summary. Instructions have been updated. (NOTE: As of 1/16/2012, protocol summary now writes itself. Information pertaining to the link no longer applies.) Study Procedures Section: Standard of care vs. research related procedures should be described if applicable. […]
Read MoreThe Tissue/Specimen Banking guidelines and checkboxes have been revised to make it clear that participants who elect to de-identify their samples waive the right to withdraw consent for future research because the samples can longer be linked to them. Consent forms with tissue banking language must be updated at the time of continuing review / […]
Read MoreNovember 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 […]
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