Human Research Protections

cid3170883979*image002.png@01D82CAB.80843F50″> Institutional Review Board Human Research Protections (HRP) – September 12, 2022 –     UPDATE: KRP form 2.0 is scheduled to be released after 5pm on September 23, 2022.   IMPACT: Drafts of new projects that are not submitted by the above deadline will be converted to form 2.0. This may result in additional prompts…

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;…

;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…

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…

 ***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…

***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…

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…

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…

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…