SCI Cancer Clinical Trials Office Blog

News & Updates from the SCI-CCTO
  • Facebook
  • Instagram
  • LinkedIn
  • Twitter
  • YouTube
  • Cancer Clinical Trials Office
  • Stanford Cancer Institute

Quality Corner: Important Information for Coordinators and Investigators

October 24, 2018 - SCI Communications

During review of monitoring reports for the last year, it was noted that numerous deviations are not being entered into OnCore. This must be completed for all studies to allow the Data and Safety Monitoring Committee to assess your study. Additionally it appears many deviations that were identified are not being reported during continuing reviews to the IRB.

This is something that will be reviewed going forward during review of outside monitoring reports and internal QA monitoring and will become a finding for your study presented to the DSMC. Please ensure patient charts are being reviewed frequently after visits to ensure deviations from the approved protocol are being noted and captured in OnCore in a timely manner. When entering a deviation into OnCore please ensure the information is full and complete so that someone not directly working with your study would understand exactly what occurred.

A deviation is defined as any occurrence happening during a clinical trial that does not occur per the IRB approved protocol. It is important to remember deviations happen! Prompt review and reporting are an important check and balance in clinical research and consistent reviews help to recognize trends so we can try to fix any issues and prevent future deviations.

If you have any questions or would like assistance identifying if something is a deviation, please contact the CCTO Quality Assurance department, dsmc-quality@stanford.edu or stop by our desks on the 3rd floor by the SRC office, and we will be happy to assist!

Blog Submissions

If you have an announcement for the blog, please complete the Comms Request Form.

Reminder: Please have your blog post submitted to us by noon on Wednesday in order to have your post featured in the weekly email digest on Friday morning.

Archives

Categories

  • Announcements
  • Clinical Trials
  • Coordinator Corner
  • Educational Training
  • Events
  • Intake Process
  • IRB Updates
  • kudos
  • OnCore
  • Quality Corner
  • Regulatory Updates
  • Remote Monitoring
  • SCI Messages
  • Scientific Review Committee (SRC)
  • SOP/Guideline Updates
  • Staff Updates
  • Uncategorized
  • Facebook
  • Instagram
  • LinkedIn
  • Twitter
  • YouTube