Reviewing IRB. The Reviewing IRB will review the continuing review/renewal request. Upon completion of the review and approval of the request, the Reviewing IRB will provide the Relying IRB with access to the documents associated with the review (an electronic copy of the request, the re-stamped, approved consent document(s) and a copy of the continuing review/renewal approval letter).
Reviewing IRB. The Reviewing IRB will review the protocol. Upon completion of review and approval of the protocol application, the Reviewing IRB will provide the Relying IRB with access to the complete protocol and supporting documents. An electronic copy of the approved informed consent document(s), and the Cover Sheet signed by a representative of the Reviewing IRB will be sent to the Relying IRB. Note that all investigator communication should be directed to the Reviewing IRB only.
Reviewing IRB. The Reviewing IRB will review the modification/amendment request. Upon completion of the review and approval of the request, the Reviewing IRB will provide the Relying IRB with notification of the review and access to a copy of the request and any revised supporting document including the revised informed consent document(s) and a copy of the modification/amendment request approval letter. If it is determined that the modification/amendment request causes the project to be more than minimal risk, this agreement cannot be used and the study must be provided for separate review by the two institutions.
Reviewing IRB. The IRB that assumes IRB responsibilities for another institution. When multiple institutions conduct the same study and one IRB will conduct the review for all study sites, the Reviewing IRB may be called a Single or Central IRB (collectively, “sIRB”).
Reviewing IRB. The Reviewing IRB will review the protocol. Upon completion of review and approval of the protocol application, the Reviewing IRB will provide the Relying IRB with an electronic copy of the Cover Sheet signed by a representative of the Reviewing IRB. The Reviewing IRB will retain copies of the complete protocol, supporting documents, approved informed consent document(s), and signed Cover Sheet. It shall not be necessary for the Reviewing IRB to forward all protocol-related documentation to the Relying IRB. However, upon request from the Relying IRB, the Reviewing IRB will forward electronic copies of protocol documentation to the Relying IRB. Note that all investigator communication with the IRB should be directed to the Reviewing IRB only.
Reviewing IRB. The Reviewing IRB will review the modification/amendment request. If it is determined that the modification/amendment request causes the project to be more than minimal risk, this agreement cannot be used and the study must be provided for separate review by the two institutions.
Reviewing IRB. The Reviewing IRB will review the proposal. Upon completion of review and approval of the research proposal, the Reviewing IRB will provide the researcher the approval letter, complete protocol and supporting documents. If UCSD is the reviewing IRB, the UCSD researcher must submit an Administrative application. In the application, indicate that UCSD will be serving as the IRB of record by selecting “Yes, UCSD IRB will be IRB of record for other sites” in the General Information section of the application in our submission platform. Then complete the Participating Site Section to add the SDSU site. In the Attachment section of the Participating Sites page, upload the SMART IRB ORS determination letter. If it is determined that the project exceeds minimal risk, this agreement cannot be used and the study must be provided for separate review by the two institutions. Relying IRB: The Relying IRB will review the documents and agree to rely on the reviewing IRB for review on the SMART IRB platform. Once the relying IRB agrees to rely on the reviewing IRB, and the reviewing IRB approves the research project, the research can commence. If UCSD is the relying site, the UCSD researcher creates and submits a “Request to Rely on non-UCSD IRB” Administrative Registration and submits a research protocol, study consent form, UCSD specific consent form (if participants will be consented at UCSD), Investigator's Brochure or Package insert (if applicable), any other study related documents, and the SDSU SMART IRB ORS Determination Letter. For more detail on the UCSD required submission process, please visit IRB Reliance (Single IRB Review) (xxxx.xxx). Modifications to an Approved Project--Amendments To initiate review of a request for modification/amendment of an approved protocol, the Principal Investigator will submit the request to the Reviewing IRB. Reviewing IRB: The Reviewing IRB will review the modification/amendment request. Upon completion of the review and approval of the request, the Reviewing IRB provides the relying researcher the amendment approval and approved documents. If it is determined that the modification/amendment request causes the project to be more than minimal risk, this agreement cannot be used and the study must be provided for separate review by the two institutions. Once the amendment is approved by the reviewing IRB, the approved changes can be implemented. If UCSD is the relying site, the UCSD researcher creates and submits an amendment to t...
Reviewing IRB. A Participating Institution who agrees to serve as the IRB of record for a specific study for one or more of the other Participating Institution(s) and/or Affiliated Organization(s).
Reviewing IRB the CTNeT cIRB that agrees to serve as the IRB of record for a specific study for one or more of the other Participating Organizations.
Reviewing IRB. This section describes the process for establishing a Reviewing IRB for any studies conducted under the SMART IRB Agreement. The process begins when a proposed human research study has been identified and an “Overall PI” has been established. The default prioritization scheme used for identifying potential Reviewing IRBs will be as follows:
