OR Human Research Protections

Important Compliance Tip: Management of Investigational Medications

Human Research Protections / March 16, 2022

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)

Human Research Protections / March 11, 2022

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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KRP: Department Chair (DC) or Organized Lead Unit Director (OLUD) Sign Off

Contract and Grant News, Human Research Protections / March 4, 2022

Institutional Review Board Human Research Protections (HRP) – Feb 28, 2022 –   Kuali Research Protocols (KRP): Department Chair (DC) or Organized Lead Unit Director (OLUD) Sign Off   Effective March 1, 2022, the IRB will require DC or OLUD sign off before releasing final protocol approval.  This is the same requirement the IRB had …

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UPDATED! Winter QRAM Agenda and Zoom Info

Human Research Protections / December 6, 2021

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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REMINDER: Winter QRAM Agenda and Zoom Info

Human Research Protections / December 1, 2021

Dear Colleagues, We are looking forward to seeing you all next Wednesday, December 8, 2021 at 10:00AM for our Winter QRAM. Below is the (light!) agenda followed by the Zoom information. Welcome and Housekeeping IACUC News C&G Accounting Updates ERA Updates Closing Barbara Inderwiesche is inviting you to a scheduled Zoom meeting. Topic: Winter QRAM …

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Kuali Research Protocols (KRP): A Note of Appreciation and an Update

Contract and Grant News, Human Research Protections / December 1, 2021

With Thanksgiving fast approaching, the Office of Research is thankful for the UCI research community’s patience and ongoing support during our transition to KRP.  As part of our continuing efforts to facilitate this transition, we recently hired a temporary, dedicated team to work on protocol transcription.  With this team now in place, we aim to …

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A note from ERA on Protocol Transcription

Contract and Grant News, Electronic Research Administration, Human Research Protections / October 26, 2021

Dear Colleagues, This email is to provide an update from ERA on protocol transcription. The current lead time for protocol transcription is up to 15 business days However, we are hopeful to reduce this time frame over the month of October Additional two part time team members dedicated to transcription Senior management, HRP and ERA …

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Kuali Research (KR) Protocols is now live!

Contract and Grant News, Human Research Protections / November 4, 2021

Dear Colleagues, Through Zot!Portal on the Research tab, there is a new portlet called “Kuali Research Protocols” where you can access the KR Protocols Portal   and the KR Protocols User Guide  . KR Protocols can also be accessed from the UCI HRP website. Materials from the recent QRAM have been posted on our Training and Education page. Please review the ERA Update …

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Kuali Research Protocols (KRP) Transition: Updated IRB Fees

Contract and Grant News, Human Research Protections / November 4, 2021

The IRB fee schedule has been simplified. Effective September 1, 2021, NEW clinical research protocols partially or fully supported by industry sponsors will be charged a ONE-TIME fee at the time of UCI or sIRB[1] approval. The ONE-TIME fee will be $1500. There will be no fee for amendments or renewals. There will be no …

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