OnCore™ Clinical Trial Management System

Once your study is Open to Enrollment, register your study participants in OnCore. As required by the Scientific Review Committee (SRC), all study participants must be registered in OnCore within 5 business days of signing the consent.

Periodically review all your studies to ensure all data are accurate. Remember, On Study Date is required in order for the participant to be counted as accrued.

• Be sure to add Screen Failures to OnCore for all open studies. The SRC and Clinical Research Groups (CRGs) review screen failures.
• Use Subject Search in the Subjects menu to generate a list of your participant data from which missing data fields can be identified.
• NOTE: Zip at Registration is not included in the Subject Search tool.

For more information, see the OnCore v13.5 quick reference guide   

Review Protocol Statuses periodically (Protocols > PC Console > Status).

If the status of your study is not correct in OnCore (ie, either Open to Accrual or Closed to Accrual), it is important that CCTO-OnCore is notified immediately. This directly impacts our internal and external reporting.    When the status of your study changes (accrual suspension, accrual closure or study termination) send an email to CCTO-OnCore@stanford.edu indicating:

• Status *
• Status Date *
• Reason for status change *
• Initiator of status change (example, PI or sponsor) *
• Include the OnCore and/or eProtocol numbers *
• If available, include activation or closure memo/document from sponsor.

Training

Register for OnCore training through Stars. Search "OnCore" to view the session. Registration should be made in advance of 4 days prior to the session. The class will be cancelled if there is less than a minimum of three people enrolled. * Please note that CITI/HIPAA training must be completed prior to OnCore access and training.

Basic Training (Required): General overview of and introduction to OnCore functionality, review of OnCore data entry requirements for research studies and hands-on practice plus OnCore homepage setup for your favorite protocols, participants, reports, searches and more

OnCore Advanced Training (optional): A monthly hands-on training session with the OnCore team. These sessions cover various topics and are designed for OnCore users who have a basic knowledge of navigation within OnCore and can perform basic data entry for Subject Registration. Current users would be trained in advanced topics to enhance their working knowledge of OnCore. Min Participants: 5, Max Participants: 15

OnCore Documents:

• Accessing OnCore (DOC) - Jan 10, 2014
• Accessing Protocol Registration Form (DOC)
• How To Find Information on Clinical Trials (DOC) - Apr 16, 2014
  
• NCI Ethnicity and Race Classification (PDF)
• OnCore v12 Comprehensive Training (PDF)
• OnCore v13.5 Quick Reference (PDF) - Apr 2015 
• OnCore v13.5 Cancer Study Subject Registration (PDF) - Apr 2015 
• OnCore DSMC Console (PDF) - Jul 2012 
• OnCore Home Screen Personalization Instructions (PDF)
• OnCore Protocol and Subject Search Overview (PDF) - May 2012 
• OnCore Subject Visit Tracking and Forms (PDF) - Jun 2012