Cancer Clinical Trials Office Blog

News & Updates from the CCTO

Subject milestone dates

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In OnCore, at the patient data entry level, we have 7 important dates that need to be entered. Between those dates we have: (the consent date, eligibility date, on study date, on treatment date, off treatment date, on follow up and off study date). These dates are not only important for patient record purposes, they also drive:

  • Accrual reporting to NCI
  • SRC accrual reviews
  • DSMC reviews for studies with active patients (on treatment)
  • Enrollment log for regulatory files

The following is a brief definition of what represents each date.

1. Consent DateConsent date is the date the subject signed the consent form.
2. Eligibility dateEligibility date is the date when the patient is confirmed to be eligible for the study.
3. On Study date   **Important: If your subject is NOT ELIGIBLE they will NOT have an On-Study date.  On Study Date is the date of first study specific Treatment/Intervention performed after eligibility has been established. The On Study Date is required in order for the participant to be counted as accrued.
4. On Treatment dateOn Treatment Date is the date when the patient first receives the study intervention (investigational product, device or other non-therapeutic intervention). For crossover studies, multiple dates can be entered.
5. Off Treatment date   **Note: Pt can still have research related follow ups after coming off treatment but remain on study.    Off treatment date is the date when the last research Treatment/Intervention is completed for the purposes of final collection of data for the primary outcome.
6. On Follow up date   **Note: Not all studies will have a follow up sections defined in the protocol.      On follow up date is the first follow up visit date as defined by the protocol and it will be on or after the Off-Treatment date.  
7.  Off Study dateOff Study date is the date the study subject stops receiving the study Treatment/Intervention or the date in which no further interaction with the subject is required.

Protocol Deviation Reporting

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What is a “Protocol” deviation?

Deviation is a variance from the approved protocol procedures. Deviations specific to an individual subject are entered via the Protocol Console > Deviations tab entered via the Subject Console > Deviations tab.

What is a “Participant/Subject” deviation?

 Deviations specific to an individual subject are entered via the Subject Console > Deviations tab.

How to enter protocol deviations in OnCore:

  1. Go to the CRA Console select the protocol and then the subject
  2. Click the Deviations vertical tab and click the “New” button on the lower right.

  3. Complete the fields “Under Subject Deviation”:
    1. Date Discovered: Enter the date the team became aware of the deviation. If multiple dates are applicable select the earliest date.
    1. Reported By: Enter the first and last name of the person who is reporting the deviation.
    1. Deviation Date: Enter the date when the deviation happened. Can be different from “Date Discovered”
    1. Category: From the drop down select the appropriate deviation categorization.
    1. Treating Physician: Enter the name of the physician
    1. Date reviewed by treating physician: Enter the date the treating physician reviewed the deviation.
    1. Description of Deviation: explain why it is a deviation. Be very precise as to dates and the decision-making processes that led to the deviation. Anyone reading the description should be able to understand the deviation without having to reference the protocol document.
    1. Effect on Patient Safety: Describe if the event affected or not affected the patient. This should be evaluated by the investigator.
    1. Action Taken: Describe if there were any action taken due to the deviation and any preventative actions taken.
    1.  Did the deviation put the participant or others at increased risk and/or negatively affect the primary study aims?: Check if applicable.
    1. Report to the IRB?: Select when the deviation needs to be reported.
    1. Date Reported to IRB: Enter the date the deviation was reported.
    1. Report to sponsor?: Check if the deviation needs to be reported to the sponsor.
    1. Date Reported to Sponsor: Enter the date the deviation was reported.
    1. Submit: Click once all of the information has been entered correctly.
    1. Print the PDF report
    1. Send it to PI to sign
    1. Save in regulatory binder (Subject/participant)
  4. Complete the same information if “Protocol” deviation

  5. How to print PDF for PI to sign
    1. PI Report Format: Once you have completed the deviation entry you can select a report type from the “PI Report Format”
    1. PI Report: Click this button to download the report.
    1. Subject Deviation PDF: Click this button to view the details.

Changes to SAE Entry in OnCore

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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

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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

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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.