SCI Cancer Clinical Trials Office Blog

News & Updates from the SCI-CCTO

New & Updated SCI SOPs

-

As discussed at our CCTO Staff Meeting on 16 Sep 2021, some of our SCI SOPs have been updated or newly created. Please review these SOPs and attest to their master on the SOP attestation survey – target by the end of September. 

  • Protocol Deviations SOP, effective 20 Sep 2021
  • Management of Site Regulatory Documentation SOP, effective 20 Sep 2021
  • Investigator‐Initiated Multi‐Site Trial Management SOP, effective 20 Sep 2021
  • Review & Prioritization of Cancer‐Related Clinical Research, effective 7 Sep 2021

SOP webpage: https://med.stanford.edu/ccto/services/regulatory.html#sops_guidelines

New SHC Investigational Drug Services Policy effective 1 September 2021

-

  • 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.

Updated SOP – Research Participant Records & Data Management in Clinical Trials

-

Version 3 of the SOP, Research Participant Records & Data Management in Clinical Trials (formerly known as Data Management in Clinical Investigations), has been updated to address source documents, source data, notes to file and data management in a more comprehensive manner. This SOP is effective 1 August 2021. Please read the SOP and complete the SOP confirmation form to attest to your mastery of the SOP – located on our CCTO website. If you have specific questions, please follow up with Quality at dsmc-quality@stanford.edu or with your manager/group leader. 

Thank you!

REDCAP request for remote monitoring

-

Q: When is the good time to submit the REDCAP request for monitoring?

A: A minimum of 14 days ahead of your scheduled monitoring request.

The record processing for remote monitoring involves CCTO-Prism, Privacy Office and HIMS IT teams. Please plan ahead and submit your monitoring request at least 14 days ahead of your scheduled monitor visit. You can always submit your records ahead of time. Your request will be cancelled if there is not enough time to process the record. Once you submit your record you should receive an automated email notification. If you do not receive any email notification please email ccto-prism@stanford.edu immediately.

For updated information and details please visit:

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

QSSG Updates

-

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!