OR Human Research Protections

UPDATED ZOOM LINK – QRAM Agenda and Zoom Info – 03/22 10AM

Hello everyone,   Please try this link for this morning’s QRAM: https://zoom.us/j/9498244789   Thank you!   Barbara   Barbara Inderwiesche, CRA Director, Electronic Research Administration     To learn more about ERA and to stay connected with the latest project developments, please sign up for the OR-ERA listserv by sending a blank email to: or-era-join@department-lists.uci.edu. …

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QRAM Agenda and Zoom Info – 03/22 10AM

Dear Colleagues,   Please join us next Wednesday, March 22, from 10AM-11:30AM for our Spring QRAM!   Below is our agenda and Zoom info:   C&G Accounting Updates Federal Updates Research Administrators United (RAU) Award Setup Process Consent addendum for the 2023 DMS requirements CT.gov Compliance CT Contracting Team Updates 700U PowerForm in DocuSign REC …

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Certificates of Confidentiality (CoC): NIH and FDA

  Institutional Review Board Human Research Protections (HRP)   Certificates of Confidentiality (CoC): National Institutes of Health (NIH) and Food and Drug Administration (FDA) Version December 7, 2022   New Resource Update!!!!   HRP has released a NEW EQUIP Tip, which provides a comprehensive step-by-step on how to obtain a CoC for a non-Federally supported study. …

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Clinical Trials.Gov Webpage Updated

Institutional Review Board Human Research Protections (HRP) – August 26, 2022 – HRP has updated the Clinical Trials.Gov Webpage to simplify content.   In addition, we have included further resources.  Please review this webpage to confirm if your study meets the one or more of the following registration requirements, and for how and when to update this record; …

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SAVE THE DATE: Fall QRAM

;widows: auto;-webkit-text-size-adjust: auto;-webkit-text-stroke-width: 0px;word-spacing:0px”>  SAVE THE DATE!    The 2022 Fall Quarterly Research Administration Meeting (QRAM) is scheduled for: Wednesday, September 28, 2022 from 10AM to 11:30AM.   Zoom info and agenda will be sent the week prior.   If you have any request for QRAM topics – or have an interesting topic you’d like to …

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New Standard Operating Procedure (SOP): Clinical Research Subject Injury

Institutional Review Board   Human Research Protections (HRP) – August 2, 2022 – __________________________     New Standard Operating Procedure (SOP): Clinical Research Subject Injury   A new standard operating procedure (SOP) addresses the provision and reimbursement of medical costs to human research participants for injuries and illnesses resulting from participation in research.   The …

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Kuali Protocols Performance Update

 ***Please read and forward to your researchers***     Dear Colleagues,   Please see below message from Kuali regarding the latest performance issues. As the first priority outlined below, Kuali is temporarily scaling back previously published validation enhancements. If you run into any problems with validations in your protocols, please contact era@research.uci.edu and someone from …

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IRB Protocol Transcription is Complete!

***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) into KR Protocols. Due to …

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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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