Research Affairs: Researcher's Alert for June 1, 2023 http://myllu.llu.edu/syncall/communityhome/?communityId=6088 en-us Thu, 09 May 2024 06:40:55 -0700 SyncAll RSS 1.0 6088:43208 <![CDATA[New Process for Reporting Serious Adverse Events and Unanticipated Problems to LLUH IRB]]> Human Research and Compliance The LLUH IRB is pleased to announce a new streamlined process for reporting Serious Adverse Events and Unanticipated Problems. All reports are to now be submitted electronically through InfoEd. The link and guidance documents can be found on the IRB toolkit webpage at: https://researchaffairs.llu.edu/research-compliance/human-studies/irb-toolkit.  Please note that if a Principal Investigator is not submitting the report themself, then they will need to login to InfoEd to sign off on the report prior to it being submitted to IRB. 

A chart is attached to help determine if your Serious Adverse Event or Unanticipated Problem is reportable and if so, what the timeline is to report.  

We are now one step closer to all submissions being fully electronic. As always, if you should have any questions or concerns, please do not hesitate to contact the LLUH IRB at: IRB@llu.edu

IRB AE UP CHART Attachment

.

]]> Thu, 01 Jun 2023 11:25:52 -0700 6088:43206 <![CDATA[OnCore Go-Live June 14, 2023]]> Human Research and Compliance Oncore, a new, enterprise-wide clinical trial management system that will support investigators, research personnel and administration in]]> As communicated in a previous Researcher's Alert, LLUH Research Affairs has been in the process of implementing Oncore, a new, enterprise-wide clinical trial management system that will support investigators, research personnel and administration in the management of clinical research. The Sprint 1 go-live will take place June 14th, 2023. As of this date, the following study types 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
  3. Any study that requires orders in LLEAP

All applicable clinical research coordinators have been contacted to complete the required training that will allow them access to OnCore. 

Research Affairs would like to thank leadership in Information Systems, Cancer Center and Clinical Trial Center for all of their hard work and support to make this implementation happen. Additionally, Research Affairs is thankful for the handful of research coordinators, finance and ancillary support teams for aiding in the implementation efforts.

Please note that School of Dentistry is not required to use OnCore at this time.

For any questions, please feel free to contact, Amy Casey, Executive Director at: acasey@llu.edu 

.

]]> Thu, 01 Jun 2023 10:34:25 -0700