Cancer Clinical Trials Office Blog

News & Updates from the CCTO

Coordinator Corner updates

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Emailing paper orders to the CCSB ITA & Pharmacy

In the past few weeks, CCSB has successfully been emailing their paper orders to their ITA (DL-CCSBStudyorders@stanfordhealthcare.org) and pharmacy (dl-ccsb-pharmacy@stanfordhealthcare.org). To make this implementation official, we updated our Emailing Paper Order Instruction to include the 2 email addresses used by CCSB.

You will find the updated Instructions (Emailing Paper Order to ITA (Informational) – Sep 27, 2021) in Coordinator Corner in the “On Study” tab under the “Treatment” subheading.

Change in ORPCS contact info

The Clinical Trials Feasibility for Nursing Services form has been updated to reflect the change in the contact info for the in-patient team over at the Office of Research Patient Care Services (ORPSC).

Study feasibility requests should now be sent to Michelle Williams, PhD, Executive Director micwilliams@stanfordhealthcare.org ; Marianne Biangone, PhD, Director of Clinical Trials Operations MBiangone@stanfordhealthcare.org ; and Chris Acidera, Sr. Program Manager CAcidera@stanfordhealthcare.org .

You will find the feasibility request form (Clinical Trials Feasibility for Nursing Services_V2.3 (Form/Logs) – Sep 27, 2021) in Coordinator Corner in the “Study Start up/Close Out” tab under the “Feasibility” subheading.

Updates to Coordinator Corner

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You may have noticed there have been some changes with Coordinator Corner! We have taken feedback and have organized the documents by task instead of type. For example, all the documents for assessing study feasibility can be found in the Study Start up/Close Out tab. We have tagged the types of the documents so you have a better idea what they contain without opening them. The tags include:

  • Checklist: tools to make sure tasks are complete
  • Form/Logs: documents to be completed
  • Guidelines: work flow instructions
  • Informational: documents that important information 
  • Notes to File: template notes to file

We have also added a feedback survey. If you notice that links aren’t working,  find that processes described are out of date or identify the need for a new document, please submit it through that survey.  

Many people have contributed to this project, including some who are no longer with the CCTO. I particularly want to thank Aja Macias, Katy McCormack, Mandie Selin, Alex Valencia and Allison Zhang for all their work to make this possible!

Thank you,

Sophie Bertrand              

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!