Cancer Clinical Trials Office Blog

News & Updates from the CCTO

Changes to SAE Entry in OnCore

-

Consistent with the new SCI Data Safety and Monitoring Plan, Serious adverse event (SAE) entry into OnCore is changing for investigator-initiated studies (IIS/IIT).  There are 2 major changes. 

  • The DSMC will review all SAEs (new and follow‑ups), instead of the previous criteria of SAEs Grade 3 and higher.  All SAEs regardless of grade should be emailed (SECURE) to CCTO-Safety@stanford.edu.
  • PI signature on the SAE form is required for OnCore submission.  CCTO-Regulatory will hold on entry of SAEs that do not have the PI signature, as the group cannot take action on medical information unless it is documented as the determination of the investigator.  Secure digital signature on the PDF form is acceptable for submission to CCTO-Safety / CCTO-Regulatory. 

SAE reports should be submitted to CCTO-Safety promptly, although there is no explicit due date. It is recommended that reports to CCTO-Safety should occur concurrent with the first notification to any other party of interest (industry collaborator, IRB, FDA, etc), which have explicit timeframes for reporting some or all SAEs.

Please ensure that all SAEs submitted to CCTO-Safety have been reviewed and signed by the investigator.

OnCore Update

-

OnCore Update: It is used to updated status, information and consents on existing studies in OnCore. So, if you need to update a status in OnCore from either (Open to Accrual, Close to accrual, suspended, terminated or abandoned), please use the OnCore update form.

The update OnCore form also covers topics related to subject delete, update inform consents, enter external IRB approvals and reconsent for ICF.

Now you may ask, how I can access the OnCore update form. The first thing you need to do is go directly to the CCTO webpage. When you are in the page, you need to go directly to our services and select OnCore. In here, located in the right side of the page, we have a section called Request OnCore Updates, Request protocol status changes, staff changes or deletion of incorrectly registered subjects. All you need to do is click on the update section and complete the form. Once the form is completed, members of the CCTO team will receive a notification and they will update the OnCore protocol according to the answers provided in the form. For any questions, please reach out to the ccto-oncore@stanford.edu mail.

CCTO OnCore protocol registration: Please use REDCap CCTO Intake form: https://redcap.stanford.edu/webauth/surveys/?s=REJM9YA7NX

Here is the screenshot in REDCap, check the 3rd box.

If you have any questions, please contact Sharmila, ccto-intake@stanford.edu email.

Accrual hold due to COVID-19 and OnCore Status update

-

Is your study on accrual hold due to COVID-19?

If your study is suspended due to COVID-19 related measures, please submit a request to update in OnCore. OnCore needs to be updated for clinical research study tracking purposes and is required by School of Medicine.

You can request for protocol accrual status update via  OnCore Updates located on OnCore’s teams homepage on the CCTO webpage at http://med.stanford.edu/ccto.html

  • Click Our Services –> OnCore
  • Go to ‘Request OnCore Updates’ (on the right side bar) –> Click the ‘Update’ button.
  • Select ‘Protocol Accrual Status Update’ option under ‘Purpose of the request’  and fill out the study information.
  • Select ‘Suspended’ under ‘New Accrual Status for the protocol’  and enter the reason for accrual status change as ‘Other’.  In “If Other, please specify” comment box, please type COVID-19.

Updating Patients’ Race/Ethnicity in OnCore based on Epic

-

Why do we need to have the correct of race and of ethnicity of a patient in OnCore?

  • National Cancer Institute (NCI) requires to provide race and ethnicity information of clinical trials’ participants for all grant applications including NCI’s grant for Stanford’s Comprehensive Cancer Center status. For definitions about race and ethnicity, please refer to the ‘NCI Ethnicity and Race Classification’ document located in the Coordinator Corner’s Forms section. After consenting to a study, CCTO leadership strongly recommends to present that from to the patient for data collection purpose.
  • When registering a participant to a trial in OnCore, please ensure that the race and ethnicity data are correct in the database and update the value(s) if needed.

Starting, April 27, 2020, OnCore Team will perform a one-time process for updating race and ethnicity data in OnCore:

  • OnCore will be updated based on Epic information of race and ethnicity to reflect correct data.  As a result, some subjects will go from unknown to a known value. If there is a single known value in Epic, and OnCore is unknown, Epic data will be considered as correct data and change will be reflected in OnCore.
  • For patient who is self-identified as a person of multi race in Epic and only has a single race value in OnCore, if first race matched, we will enter the other race values in OnCore as they were record in Epic.
  • If there is a discrepancy between race/ethnicity values from two Epic Hospitals (S- SHC Adult Epic, and L- LPCH Peds Epic). We will go with whichever Hospital value is most appropriate for the Adult or Pediatric study.
  • If OC and Epic does not match, OnCore will remain the same; additional race might be added in OC if there are multiple races in Epic.

Priority: 

  • There are around 1200 subjects’ records which need to be updated in OnCore, we will first update subjects with on-study date from 2018 to 2020.

Forms section link: http://med.stanford.edu/ccto/staff-resources/coordinators-corner.html#forms

What is the ‘Transferred Date’ field in OnCore?

-

The ‘Transferred Date’  field is located on ‘On Study’ tab of a patient record.  This field is used when a patient who was enrolled on the same protocol at another institution was transferred to Stanford to complete the study in our facilities.  When a patient transferred out of Stanford or transferred another research protocol, the ‘Transferred Date’  field should remain blank.