Research Affairs: Researcher's Alert for January 24, 2024 http://myllu.llu.edu/syncall/communityhome/?communityId=6088 en-us Wed, 08 May 2024 23:40:06 -0700 SyncAll RSS 1.0 6088:43590 <![CDATA[Tips on Submitting and Maintaining a New Study with the IRB]]> Human Research and Compliance Research Compliance would like to invite ALL Researchers (Investigators, Coordinators, Students, Residents, and Fellows) to attend a Four-Part Virtual Series Presentation by the IRB Administrator via Zoom as follows:

Part 1: Date/Time: March 15, 2024, Noon – 1:00 PM

Topics:

  • Meet the IRB Staff
  • Understand the role of the IRB
  • Understand the Education Requirements for Human Subject’s Research
  • Understand the purpose and use of InfoEd
  • Determine if your study requires IRB oversight
  • Identify the three levels of IRB review
  • Know how to prepare your initial consent for IRB submission
  • Understand the use of CESBOR and HIPAA Auth

Part 2: Date/Time: March 29, 2024, Noon – 1:00 PM

Topics:

  • Understand what it takes to prepare your initial IRB submission packet
  • Understand how to avoid delays in the IRB review process

Part 3: Date/Time: April 12, 2024, Noon – 1:00 PM

Topics:

  • Understand the IRB Review process and conditions of approval
  • Know how to manage your approved study 

Part 4: Date/Time: April 26, 2024, Noon – 1:00 PM

Topics:

  • Understand the process and importance of renewing your study
  • Know when to close out your study
  • Know the required Record Retention policy for your study
  • Understand how to manage a Regulatory Binder

Each meeting will use the same link:

https://llu.zoom.us/j/91549162966?pwd=TFdHKzloN3RpSHE0WGdoRVZkNW1NZz09

]]> Tue, 23 Jan 2024 09:37:44 -0800 6088:43589 <![CDATA[OnCore Sprint 2 Go-Live]]> Research Affairs As communicated in previous Researcher’s Alerts, LLUH Research Affairs has been in the process of implementing Oncore, a new, enterprise-wide clinical trial management system that serves to support the LLUH community engaged in clinical research. The Sprint 2, and final go-live will take place Wednesday January 24, 2024. The purpose of this final go-live is to implement both financial and calendar integrations between Oncore and LLEAP, as well as some integration between InfoEd and Oncore as it pertains to IRB.  All affected clinical research coordinators have been contacted about any further required training for this go-live. The Oncore implementation effort has been time consuming for all parties involved and Research Affairs is thankful for the dedication of all involved. As a reminder, the following clinical research studies are REQUIRED to be entered into OnCore: 

1. All studies with billable items or services-regardless of sponsor/funder- requiring a coverage analysis

2. All studies that meet the NIH clinical trial definition regardless of billables

For any questions, please feel free to email the dedicated email box at: Oncore@llu.edu or feel free to reach out to Amy Casey, Executive Director at: acasey@llu.edu

 

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