IRB Protocol Transcription is Complete!

;widows: auto;-webkit-text-size-adjust: auto;-webkit-text-stroke-width: 0px;word-spacing:0px”>***Please read and forward to your researchers***   Dear Colleagues,   This email is to inform you that the protocol transcription project for IRB protocols is now complete. This excludes exempt protocols which will still need an adhoc transcription. The Temporary Transcription Team (TTT) has transcribed 1500+ protocols from our previous system(s)…

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HRP Spring Update: Tips on Informed Consent

HRP Spring Update: Tips on Informed Consent View this email in your browser Keep in mind the following when considering the research informed consent process at UCI: Use the latest UCI Institutional Review Board (IRB) and Single IRB (sIRB) Consent templates. Effective April 1, 2022: Use of the most recent consent templates will be required…

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Spring QRAM 2022 03/23 – Agenda and Zoom Info

Dear Colleagues,   Next Wednesday, 03/23, is our Spring QRAM. It is scheduled via Zoom from 10-1130 AM. See below for the agenda and the Zoom info.   March 23, 2022 Agenda Welcome and Housekeeping Oracle Cloud Financials – Exploratory Phase Area Updates: Sponsored Projects Administration Research Engagement and Compliance Contracts & Grants Accounting Human…

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Important Compliance Tip: Management of Investigational Medications

UCI Health policy requires that investigational medications are under the control of Investigational Drug Services (IDS) Pharmacy. View this email in your browser An Important Compliance Tip from Compliance + Pharmacy: Management of Investigational Medications In order to promote a commitment to compliance with FDA regulations and Good Clinical Practice (GCP) guidelines, UCI Health policy…

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China’s Personal Information Protection Law (PIPL)

View this email in your browser China’s Personal Information Protection Law (PIPL) China has a new Personal Information Protection Law: the PIPL.  The PIPL applies to the processing of personal information of individuals living in mainland China on or after November 1, 2021 UC is required to comply with PIPL if conducting any activity in…

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Kuali Research Protocols (KRP): Administrative Determination vs a Protocol for IRB Review

There are 3 types of applications in KRP.   Keep this reference on hand when navigating human subject research at UCI. Non-Human Subjects Research (NHSR) Self-Determination Exempt Self-Determination UCI allows Exempt Self-Determination for Categories 1-4ii. There are exceptions for certain populations and procedures. Exempt Research that Requires IRB Approval Exempt research that is not eligible for…

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Kuali Research Protocols (KRP): Department Chair Sign Off

Kuali Research Protocols (KRP):  Department Chair Sign Off Coming March 1, 2022, Department Chair (or their designee) sign off will be required before final IRB approval can be released.  As a reminder, this is the same requirement the IRB had prior to migration to KRP.  Why is Department Chair Review Needed? The IRB, in conjunction…

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UPDATED! Winter QRAM Agenda and Zoom Info

Dear Colleagues, We have an updated (still light) agenda for Wednesday’s QRAM below. Looking forward to “seeing” you all! Welcome and Housekeeping IACUC News Property / Equipment Procedure SPA Updates C&G Accounting Updates ERA Updates Closing Barbara Barbara Inderwiesche, CRA Director, Electronic Research Administration image001.png@01D78AA3.370D2670″> From: OR-IRB-HRP <or-irb-hrp-bounces@department-lists.uci.edu&gt; On Behalf Of Office of Research Human…

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