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Remember: Kuali Research Protocols (KRP) transactions not IRB approved by September 4, 2025 will need to be re-entered into ZOT IRB. KRP is no longer in use.
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Review the transition webpage to know what Word documents are required for current IRB and hSCRO approved studies and new submissions.
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Refer to the HRP Toolkit for all IRB documents. Refer to hSCRO Forms and Guidance for all hSCRO documents.
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If changes are being made to the protocol at the time of renewal, a Modification and Continuing Review transaction must be submitted. This includes updating existing documents, providing new documents, and/or transcribing a protocol.
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Remember to have your Principal Investigator (PI) establish a PI Proxy in the main study space of the SmartForm. This will allow members of the study team to edit and submit on behalf of the PI.
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Establish PI Proxy before you start your follow-on transaction. Once a follow-on transaction has been initiated (e.g., modification and/ or renewal), and then the PI Proxy is established, the PI Proxy will not be able to submit. The transaction must be completed and submitted by the PI (or abandoned). The next subsequent transaction will allow for the PI Proxy to submit.
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When drafting the IRB or hSCRO application, consider starting with the Protocol Narrative. For IRB: The applicable Word version of the Protocol Narrative will guide you on what PI Worksheets should also be attached. For hSCRO: The Protocol Narrative will guide you on what policies apply and which further documents may need to be included in the submission.
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For reliance submissions, start with the appropriate PI Worksheet.
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When completing the IRB or hSCRO Protocol Narrative, read each section carefully. Not all sections may be relevant to your research! Complete only those that apply.
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Submitters are adding documents via the “Add Comment” feature. Note: these documents cannot be affixed with the IRB approval stamp, and they do not show in the documents tab for the study. For IRB: Upload documents that will need an IRB approval stamp within the SmartForm.
