New SHC Investigational Drug Services Policy effective 1 September 2021

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  • Starting September 1, 2021, only 1 IDS pharmacist will sign the delegation of authority log (DOA) for a study. IDS staff will sign off on competencies (or training logs) for specific studies to document training
    • Technicians will no longer sign DOA
  • New Protocol-Specific Training workflow
    • Pharmacist on DOA will train all pharmacy staff that perform study-specific tasks
    • A study-specific competency in Vestigo will be created for each new protocol. 
    • Delegated pharmacist will send an email to IDS staff to review training materials and to self-acknowledge when training is completed.
  • Protocol Amendments/Pharmacy Manual Changes
    • A study-specific competency for the amendment with a summary of pharmacy-related changes will be created and shared with all other IDS staff. 
    • Each staff member will self-acknowledge competency after reviewing the materials. 
  • IDS staff do not document training for the following: investigator’s brochure, IWRS training, and Investigator Training Platforms
  • CRAs will access the training competencies during their pharmacy remote visit.
    • The training competency will be visible to the CRA via Vestigo Verify during their access time.
    • It is the responsibility of the CRA to obtain this document if so needed.
  • Copies of licenses or CVs will not be provided for any pharmacy staff as they should NOT be listed on the 1572. 
  • Pharmacist and technician licenses can be verified online through the California Board of Pharmacy website. We will no longer provide them.

REDCAP request for electronic monitoring Updates:

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  1. Expanded Access for Prism Monitoring: 

    New expanded access time for Prism Monitors is from 5:00 AM PST T0 8:00 PM PST. Please inform the monitors about the staff coverage or customer service issues for Monitors from different time zones in US
  1. Reminder: Request for records release MUST BE submitted at least 14 days in advance. 

    The 14-Day time frame starts when you receive an automated notification after you submit the record for release in REDCAp. If you do not receive any email notification please email ccto-prism@stanford.edu immediately.
  1. Submitting monitoring records for pediatric studies.

    Most pediatric records are stored in children EPIC. If the records are in Children EPIC, the monitoring requests should be made via Stanford Children’s Health (SCH) Epic Access for Research Monitors and NOT via CCTO Monitoring Requests System.

    https://med.stanford.edu/mchri/crso/epic/stanford-children-s-health-epic-access-for-monitors-research-onl.html
  1. Termination of Monitor Access in REDCAp is Live.

    You can submit the request to terminate monitor access to Prism via REDCap

For all updated information regarding electronic monitoring and details please visit

https://med.stanford.edu/ccto/staff-resources/remote-monitoring.html

QSSG Updates

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The QSSG has replaced the SOP on FDA Inspection with the Spectrum SOP. Please review the updated document and update your attestation

We’ve updated some guidelines.

-Posted Opening an IIT

-Requesting Tissue from Pathology: Added a distribution list email for pathology

– Completing FDA Form 1572 to provide clarification on sub-investigators.

-We’ve also developed a new guideline on training.

Check them out!

Emailing Paper Orders to the ITA and Change in ORPCS Contact Info

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Emailing paper orders to the ITA
Paper orders and consents can now be emailed to ITA at this address: ITAStudyorders@stanfordhealthcare.org .
Since the initial pilot project with the Breast Oncology team which started on 1/4/2021 was a success, the initiative will be rolled out to the rest of the CRGs starting 2/15/2021.

You will find the Emailing instructions in Coordinator Corner in “Guidelines for practice” tab under the subheading “treatment areas”

Change in ORPCS contact info

The Clinical Trials Feasibility for Nursing Services form and the Scheduling a Remote In-Service with Service Centers guidelines have been updated to reflect the change in the contact info over at the Office of Research Patient Care Services (ORPSC).

Study feasibility and In-service requests should now be sent to Roxabeth Frausto (RFrausto@stanfordhealthcare.org), Research associate, and Michelle Williams (micwilliams@stanfordhealthcare.org), executive director.

You will find the feasibility request form in Coordinator Corner in “CRFs/Forms” tab under the subheading “REDCap Forms”, and the Guidelines in the “Guidelines for Practice” tab under the subheading “treatment areas.”

Medical Records Office: Communications Update

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We have received confirmation that the Medical Records office is accepting faxed patient records. Please see requirements and instructions below.

  • If a patient is already established in the medical records system, you may fax the medical record to the Medical Records office.
  • EXCEPTIONS:
    • If the medical records come through by fax illegible/hard to read, then the process of sending a hard copy to the Medical Records office must still be used.
    • If the patient isn’t already established in the medical records system, a hard copy must be sent to the Medical Records office to establish the record.
  • Once received, the Medical Records office will send to the scanning office/HIMS and the document will be uploaded to EPIC within three to four days.

Medical Record’s fax number is 650-725-9821

CCTO staff may use the already established Cardinal Fax process to send remotely. Any questions or concerns can be emailed to ccto-admin@stanford.edu.