Page 63 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-004 SOP Title: Study Initiation with Pharmacy
o Pharmacymanual
o Estimated start date of study
o Estimatednumberofsubjectsbeingenrolled
• Request system(s) access for IDS staff when applicable (IXRS, IVRS, IWRS, etc.)
• Upload copy of delegation log into Velos – IDS refers to this to verify the physician ordering the IP has been delegated this task.
5.2 Notification of Meetings
Send calendar appointment to IDSRx email for all sponsor/monitor visits that include the pharmacy staff (SQV, SIV, IMV, Close-out). Schedule all appointments and meetings at the soonest opportunity and at least 48 hours prior to the time of the event.
5.3 Update IDS Pharmacy with new information
• Update IDS of study IRB approval status
• Notify IDS of each new potential patient’s screening visit (provide name, DOB,
MRN, and subject number, if available)
• Upload updated versions of the delegation log, as necessary
• Forward all updates to Protocol, IB, and Pharmacy Manuals to the IDS
• Inform IDS of any upcoming IP shipments, if known
5.4 Study IP Order (Set) in EPIC
• Work with IDS Pharmacy to ensure the build of the order/order set in EPIC
• Set a meeting with IDS and PI in order to familiarize how to navigate EPIC to
order the study drug.
Note: A credentialed, and delegated physician must order the investigational drug or intervention for subjects meeting all inclusion and no exclusion criteria.
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