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New SHC Investigational Drug Services Policy effective 1 September 2021

September 9, 2021 - SCI Communications

  • 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.

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