- 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.