When: October 16, 2024, 5pm PST
What is changing?
- Study Staff lists and Study Status updates will be made in OnCore only and will automatically push from OnCore to APeX every four hours.
- You will no longer be required to submit a ServiceNow request (APeX CRC Change to Study) for staff updates in APeX, except to update the Billing Contact.
- This enhancement reduces duplicative work and improves data quality. However, study teams must continue to verify and maintain accurate protocol statuses and staff lists in OnCore to ensure continued access and research compliance.
- All studies using APeX research features, will require one study team member to have OnCore access to manage the staff list and protocol status within the systems.
Important Notes:
- The upgraded interface between OnCore and APeX allows for automatic protocol-level updates to APeX.
- This improvement reinforces UCSF’s commitment to research compliance.
- Please note: The staff list in OnCore will overwrite study staff information previously entered in APeX. Ensure study staff who require APeX research access are assigned the appropriate mapped role in OnCore. This is found under “Staff List Mapping” in the Updating the Staff List quick guide.
Action Required: Before Wednesday, October 16th, please complete the following steps to ensure accurate and compliant protocol data:
For quick reference OnCore/APeX Tracking Requirements for Study Teams.
For Inactive Studies:
- Ensure all completed visits are recorded in OnCore as per the Subject Visit Tracking quick guide.
- Update patient statuses to an inactive status (Off Study, Withdrawn, Not Eligible, or Expired) following the Subject Enrollment and Management quick guide.
- Follow the Study Close-out Checklist and the Study Closure Quick Guide to update the protocol status in OnCore & Billing Status in APeX.
For Active Studies:
- If your study staff are not currently using OnCore and you are using APeX research features (i.e., MyChart Recruitment) ensure one study team member has access to OnCore to manage the staff list and protocol status within the systems. More information here to obtain OnCore Access.
- Review and Update the Staff List for your protocols in OnCore. Ensure study staff who require APeX research access are assigned the appropriate mapped role in OnCore. This is found under “Staff List Mapping” in the Updating the Staff List quick guide.
- Review and Update Study Status in OnCore.
For more information:
- Join us for OnCore Upgrade Office Hours, 12-1pm on Tuesday, October 8th.
- For questions or support, contact the OnCore Helpdesk at [email protected] or 415-502-2962.
- OnCore quick guides: https://trialactivation.ucsf.edu/oncore-resources